Trial Outcomes & Findings for A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis (NCT NCT00976599)
NCT ID: NCT00976599
Last Updated: 2013-01-09
Results Overview
Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.
COMPLETED
PHASE2
29 participants
Day -7 (Baseline), Day 28
2013-01-09
Participant Flow
Participant milestones
| Measure |
CP-690,550
CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
53.5 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
53.1 years
STANDARD_DEVIATION 14.3 • n=107 Participants
|
53.3 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day -7 (Baseline), Day 28Population: Full analysis set (FAS) included all randomized participants who received at least 1 dose of the study medication. Analyses of tumor necrosis factor alpha(TNFα), receptor activator of nuclear factor kappa-B ligand(RANKL), osteoprotegerin(OPG) were not performed due to insufficient samples and lack of appropriate method to process/analyze samples.
Synovial tissue biopsy were performed and assayed for mRNA gene expression by quantitative polymerized chain reaction (PCR) using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Interleukin-1beta (IL-1beta), IL-6, matrix metalloproteinase-3 (MMP3), cluster of differentiation 19 (CD19), cluster of differentiation 3 epsilon (CD3E), Janus kinase 1 (JAK1), JAK2, JAK3, signal transducers, activators of transcription (STAT1), interferon stimulated gene 15 (ISG15), C-X-C motif chemokine 10 (CXCL10), chemokine (C-C motif) ligand2 (CCL2), phospho-STAT1 (pSTAT1), pSTAT3, tumor necrosis factor alpha (TNFalpha), receptor activator of nuclear factor kappa-B ligand (RANKL) and osteoprotegerin (OPG) presented as control gene normalized expression (relative expression) within synovial tissue.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: IL-1beta mRNA
|
-2.73 relative expression unit (REU)
Standard Deviation 0.77
|
-2.83 relative expression unit (REU)
Standard Deviation 0.80
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: IL-6 mRNA
|
-3.72 relative expression unit (REU)
Standard Deviation 0.67
|
-3.96 relative expression unit (REU)
Standard Deviation 0.55
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: MMP3 mRNA
|
-2.01 relative expression unit (REU)
Standard Deviation 1.39
|
-2.52 relative expression unit (REU)
Standard Deviation 1.64
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: CD19 mRNA
|
-2.98 relative expression unit (REU)
Standard Deviation 1.25
|
-3.46 relative expression unit (REU)
Standard Deviation 1.34
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: CD3E mRNA
|
-1.58 relative expression unit (REU)
Standard Deviation 0.71
|
-1.75 relative expression unit (REU)
Standard Deviation 0.58
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: JAK1 mRNA
|
0.30 relative expression unit (REU)
Standard Deviation 0.24
|
0.31 relative expression unit (REU)
Standard Deviation 0.29
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: JAK2 mRNA
|
0.17 relative expression unit (REU)
Standard Deviation 0.26
|
0.15 relative expression unit (REU)
Standard Deviation 0.25
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: JAK3 mRNA
|
-0.77 relative expression unit (REU)
Standard Deviation 0.40
|
-0.88 relative expression unit (REU)
Standard Deviation 0.52
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: STAT1 mRNA
|
-0.43 relative expression unit (REU)
Standard Deviation 0.29
|
-0.46 relative expression unit (REU)
Standard Deviation 0.33
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: ISG15 mRNA
|
-1.26 relative expression unit (REU)
Standard Deviation 0.23
|
-1.33 relative expression unit (REU)
Standard Deviation 0.27
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: CXCL10 mRNA
|
-1.21 relative expression unit (REU)
Standard Deviation 0.85
|
-1.24 relative expression unit (REU)
Standard Deviation 0.81
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: CCL2 mRNA
|
-1.70 relative expression unit (REU)
Standard Deviation 0.29
|
-1.73 relative expression unit (REU)
Standard Deviation 0.39
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: pSTAT1 protein
|
0.18 relative expression unit (REU)
Standard Deviation 0.33
|
0.27 relative expression unit (REU)
Standard Deviation 0.39
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Baseline: pSTAT3 protein
|
0.77 relative expression unit (REU)
Standard Deviation 0.29
|
0.79 relative expression unit (REU)
Standard Deviation 0.30
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: IL-1beta mRNA
|
-0.01 relative expression unit (REU)
Standard Deviation 0.88
|
0.09 relative expression unit (REU)
Standard Deviation 0.43
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: IL-6 mRNA
|
-0.25 relative expression unit (REU)
Standard Deviation 0.86
|
-0.08 relative expression unit (REU)
Standard Deviation 0.45
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: MMP3 mRNA
|
-0.80 relative expression unit (REU)
Standard Deviation 0.92
|
-0.03 relative expression unit (REU)
Standard Deviation 1.23
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: CD19 mRNA
|
0.06 relative expression unit (REU)
Standard Deviation 0.85
|
-0.31 relative expression unit (REU)
Standard Deviation 0.72
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: CD3E mRNA
|
-0.07 relative expression unit (REU)
Standard Deviation 0.53
|
-0.12 relative expression unit (REU)
Standard Deviation 0.44
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: JAK1 mRNA
|
0.04 relative expression unit (REU)
Standard Deviation 0.36
|
-0.10 relative expression unit (REU)
Standard Deviation 0.36
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: JAK2 mRNA
|
-0.07 relative expression unit (REU)
Standard Deviation 0.40
|
-0.10 relative expression unit (REU)
Standard Deviation 0.29
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: JAK3 mRNA
|
-0.05 relative expression unit (REU)
Standard Deviation 0.35
|
-0.13 relative expression unit (REU)
Standard Deviation 0.52
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: STAT1 mRNA
|
-0.15 relative expression unit (REU)
Standard Deviation 0.46
|
0.01 relative expression unit (REU)
Standard Deviation 0.35
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: ISG15 mRNA
|
-0.16 relative expression unit (REU)
Standard Deviation 0.40
|
0.11 relative expression unit (REU)
Standard Deviation 0.34
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: CXCL10 mRNA
|
-0.49 relative expression unit (REU)
Standard Deviation 0.75
|
0.15 relative expression unit (REU)
Standard Deviation 0.61
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: CCL2 mRNA
|
-0.20 relative expression unit (REU)
Standard Deviation 0.30
|
-0.02 relative expression unit (REU)
Standard Deviation 0.28
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: pSTAT1 protein
|
-0.20 relative expression unit (REU)
Standard Deviation 0.44
|
-0.10 relative expression unit (REU)
Standard Deviation 0.36
|
|
Change From Baseline in Synovial Tissue Messenger Ribonucleic Acid (mRNA) Expression at Day 28
Change at Day 28: pSTAT3 protein
|
-0.10 relative expression unit (REU)
Standard Deviation 0.42
|
-0.10 relative expression unit (REU)
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: Baseline (Day -7), Day 28Population: Analyses of TNFalpha, IL-6, IL-17 and IL-10 were not performed due to insufficient samples and lack of appropriate method to process/analyze the samples.
Synovial tissue biopsy was to be performed and assayed for protein expression by quantitative PCR using standard curve method. Standard curve was to be generated by linear regression using log threshold cycle versus log (cell number). TNFalpha, IL-6, IL-17 and IL-10 data were to be presented as control normalized expression (relative expression) within synovial tissue.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline (Day -7), Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable at specific time points for each arm group, respectively.
The intensity of CD3 and CD68 cell infiltration was expressed as the percentage area of the tissue section occupied by positively stained cells. Surface marker CD68 macrophages and CD3 thymus cells (T cells) in the inflammatory cells of synovial tissue were detected by immunohistochemical staining.
Outcome measures
| Measure |
CP-690,550
n=12 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28
Baseline: CD3+ Cells (n=12, 12)
|
7.33 percentage area stained
Standard Deviation 6.12
|
7.92 percentage area stained
Standard Deviation 7.49
|
|
Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28
Baseline: CD68+ Cells (n=12, 13)
|
31.83 percentage area stained
Standard Deviation 20.59
|
32.85 percentage area stained
Standard Deviation 26.05
|
|
Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28
Change at Day 28: CD3+ Cells (n=10, 8)
|
1.50 percentage area stained
Standard Deviation 3.95
|
0.13 percentage area stained
Standard Deviation 7.38
|
|
Change From Baseline in Percentage of Area Stained For CD3+ and CD68+ Surface Markers of Inflammatory Cells of the Synovial Tissue at Day 28
Change at Day 28: CD68+ Cells (n=12, 11)
|
1.67 percentage area stained
Standard Deviation 19.86
|
0.82 percentage area stained
Standard Deviation 18.37
|
PRIMARY outcome
Timeframe: Baseline (Day -7)Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3 epsilon (CD3E), STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
CD19 mRNA
|
0.11 REU
Standard Deviation 0.28
|
0.29 REU
Standard Deviation 0.25
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
CD3E mRNA
|
0.41 REU
Standard Deviation 0.44
|
0.40 REU
Standard Deviation 0.38
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
STAT1 mRNA
|
0.06 REU
Standard Deviation 0.25
|
0.02 REU
Standard Deviation 0.13
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
STAT3 mRNA
|
0.61 REU
Standard Deviation 0.13
|
0.64 REU
Standard Deviation 0.08
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
ISG15 mRNA
|
-0.65 REU
Standard Deviation 0.45
|
-0.56 REU
Standard Deviation 0.47
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Baseline (Day-7)
CXCL10 mRNA
|
-1.58 REU
Standard Deviation 0.33
|
-1.65 REU
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood levels were utilized for expression analysis (mRNA) of following genes that reflect immune function: CD19, CD3E, STAT1, STAT3, ISG15, CXCL10. mRNA gene expression in blood were assayed by quantitative PCR using standard curve method. Standard curve generated by linear regression using log threshold cycle versus log (cell number). Data were presented as control gene normalized expression (relative expression) within blood.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
CD19 mRNA
|
0.35 REU
Standard Deviation 0.24
|
0.30 REU
Standard Deviation 0.25
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
CD3E mRNA
|
0.49 REU
Standard Deviation 0.34
|
0.40 REU
Standard Deviation 0.32
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
STAT1 mRNA
|
-0.01 REU
Standard Deviation 0.28
|
0.04 REU
Standard Deviation 0.21
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
STAT3 mRNA
|
0.60 REU
Standard Deviation 0.13
|
0.59 REU
Standard Deviation 0.13
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
ISG15 mRNA
|
-0.93 REU
Standard Deviation 0.20
|
-0.48 REU
Standard Deviation 0.51
|
|
Blood Levels for Gene Expression (Messenger Ribonucleic Acid [mRNA]) at Day 28
CXCL10 mRNA
|
-1.64 REU
Standard Deviation 0.22
|
-1.59 REU
Standard Deviation 0.28
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, active 70 kDa (p70) form of IL-12(IL-12p70), interferon gamma (IFNgamma) - induced protein 10 (IP-10), TNFalpha, granulocyte macrophage colony-stimulating factor (GM-CSF), macrophage inflammatory protein 1 alpha (MIP1a), monocyte chemotactic protein 1 (MCP1), soluble vascular endothelial growth factor (sVEGF), soluble vascular cell adhesion molecule 1 (sVCAM-1), soluble intercellular adhesion molecule 1 (sICAM-1), granulocyte colony-stimulating factor (G-CSF) was measured by immunoassay and the levels were expresses as picogram per milliliter (pg/mL).
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-12p70
|
0.31 pg/mL
Standard Deviation 0.29
|
0.35 pg/mL
Standard Deviation 0.44
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-17A
|
0.49 pg/mL
Standard Deviation 0.48
|
0.44 pg/mL
Standard Deviation 0.37
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-21
|
1.56 pg/mL
Standard Deviation 1.10
|
1.47 pg/mL
Standard Deviation 1.04
|
|
Blood Cytokine Level at Pre-dose on Day 1
IP-10
|
2.22 pg/mL
Standard Deviation 0.23
|
2.23 pg/mL
Standard Deviation 0.30
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-1alpha
|
0.75 pg/mL
Standard Deviation 0.68
|
0.67 pg/mL
Standard Deviation 0.68
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-1beta
|
0.42 pg/mL
Standard Deviation 0.39
|
0.41 pg/mL
Standard Deviation 0.41
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-4
|
0.29 pg/mL
Standard Deviation 0.29
|
0.17 pg/mL
Standard Deviation 0.16
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-6
|
0.97 pg/mL
Standard Deviation 0.67
|
0.77 pg/mL
Standard Deviation 0.45
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-7
|
0.89 pg/mL
Standard Deviation 0.32
|
0.74 pg/mL
Standard Deviation 0.23
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-8
|
1.17 pg/mL
Standard Deviation 0.24
|
1.19 pg/mL
Standard Deviation 0.27
|
|
Blood Cytokine Level at Pre-dose on Day 1
IL-10
|
0.25 pg/mL
Standard Deviation 0.24
|
0.33 pg/mL
Standard Deviation 0.37
|
|
Blood Cytokine Level at Pre-dose on Day 1
TNFalpha
|
0.45 pg/mL
Standard Deviation 0.43
|
0.44 pg/mL
Standard Deviation 0.51
|
|
Blood Cytokine Level at Pre-dose on Day 1
IFNgamma
|
0.15 pg/mL
Standard Deviation 0.16
|
0.11 pg/mL
Standard Deviation 0.07
|
|
Blood Cytokine Level at Pre-dose on Day 1
G-CSF
|
0.57 pg/mL
Standard Deviation 0.47
|
0.60 pg/mL
Standard Deviation 0.34
|
|
Blood Cytokine Level at Pre-dose on Day 1
GM-CSF
|
0.48 pg/mL
Standard Deviation 0.48
|
0.36 pg/mL
Standard Deviation 0.46
|
|
Blood Cytokine Level at Pre-dose on Day 1
MCP1
|
2.14 pg/mL
Standard Deviation 0.26
|
2.09 pg/mL
Standard Deviation 0.32
|
|
Blood Cytokine Level at Pre-dose on Day 1
MIP1a
|
0.85 pg/mL
Standard Deviation 0.45
|
0.90 pg/mL
Standard Deviation 0.32
|
|
Blood Cytokine Level at Pre-dose on Day 1
sVEGF
|
1.96 pg/mL
Standard Deviation 0.44
|
1.87 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at Pre-dose on Day 1
sVCAM-1
|
4.95 pg/mL
Standard Deviation 0.17
|
5.07 pg/mL
Standard Deviation 0.17
|
|
Blood Cytokine Level at Pre-dose on Day 1
sICAM-1
|
4.65 pg/mL
Standard Deviation 0.12
|
4.76 pg/mL
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: 1 hour post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-1alpha
|
0.76 pg/mL
Standard Deviation 0.68
|
0.73 pg/mL
Standard Deviation 0.68
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-1beta
|
0.43 pg/mL
Standard Deviation 0.42
|
0.40 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-4
|
0.29 pg/mL
Standard Deviation 0.28
|
0.15 pg/mL
Standard Deviation 0.13
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-6
|
0.90 pg/mL
Standard Deviation 0.52
|
0.78 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-7
|
0.86 pg/mL
Standard Deviation 0.36
|
0.72 pg/mL
Standard Deviation 0.26
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-8
|
1.12 pg/mL
Standard Deviation 0.31
|
1.15 pg/mL
Standard Deviation 0.23
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-10
|
0.23 pg/mL
Standard Deviation 0.22
|
0.31 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-12p70
|
0.36 pg/mL
Standard Deviation 0.31
|
0.34 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-17A
|
0.58 pg/mL
Standard Deviation 0.46
|
0.42 pg/mL
Standard Deviation 0.36
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IL-21
|
1.45 pg/mL
Standard Deviation 1.16
|
1.45 pg/mL
Standard Deviation 1.07
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IP-10
|
2.17 pg/mL
Standard Deviation 0.25
|
2.22 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
TNFalpha
|
0.41 pg/mL
Standard Deviation 0.46
|
0.44 pg/mL
Standard Deviation 0.52
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
IFNgamma
|
0.12 pg/mL
Standard Deviation 0.07
|
0.10 pg/mL
Standard Deviation 0.00
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
G-CSF
|
0.56 pg/mL
Standard Deviation 0.47
|
0.62 pg/mL
Standard Deviation 0.36
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
GM-CSF
|
0.49 pg/mL
Standard Deviation 0.49
|
0.39 pg/mL
Standard Deviation 0.49
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
MCP1
|
2.09 pg/mL
Standard Deviation 0.26
|
2.03 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
MIP1a
|
0.83 pg/mL
Standard Deviation 0.47
|
0.89 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
sVEGF
|
1.98 pg/mL
Standard Deviation 0.42
|
1.87 pg/mL
Standard Deviation 0.27
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
sVCAM-1
|
4.94 pg/mL
Standard Deviation 0.15
|
5.06 pg/mL
Standard Deviation 0.17
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 1
sICAM-1
|
4.64 pg/mL
Standard Deviation 0.13
|
4.76 pg/mL
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: 4 hours post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-1alpha
|
0.77 pg/mL
Standard Deviation 0.69
|
0.65 pg/mL
Standard Deviation 0.70
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-1beta
|
0.43 pg/mL
Standard Deviation 0.46
|
0.41 pg/mL
Standard Deviation 0.42
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-4
|
0.28 pg/mL
Standard Deviation 0.28
|
0.18 pg/mL
Standard Deviation 0.17
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-6
|
0.74 pg/mL
Standard Deviation 0.41
|
0.72 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-7
|
0.82 pg/mL
Standard Deviation 0.39
|
0.73 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-8
|
1.18 pg/mL
Standard Deviation 0.22
|
1.15 pg/mL
Standard Deviation 0.25
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-10
|
0.19 pg/mL
Standard Deviation 0.20
|
0.30 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-12p70
|
0.35 pg/mL
Standard Deviation 0.29
|
0.38 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-17A
|
0.53 pg/mL
Standard Deviation 0.47
|
0.39 pg/mL
Standard Deviation 0.40
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IL-21
|
1.60 pg/mL
Standard Deviation 1.09
|
1.36 pg/mL
Standard Deviation 1.07
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IP-10
|
2.10 pg/mL
Standard Deviation 0.22
|
2.20 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
TNFalpha
|
0.41 pg/mL
Standard Deviation 0.47
|
0.45 pg/mL
Standard Deviation 0.51
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
IFNgamma
|
0.17 pg/mL
Standard Deviation 0.13
|
0.12 pg/mL
Standard Deviation 0.07
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
G-CSF
|
0.55 pg/mL
Standard Deviation 0.47
|
0.62 pg/mL
Standard Deviation 0.41
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
GM-CSF
|
0.50 pg/mL
Standard Deviation 0.48
|
0.38 pg/mL
Standard Deviation 0.48
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
MCP1
|
1.98 pg/mL
Standard Deviation 0.29
|
2.07 pg/mL
Standard Deviation 0.34
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
MIP1a
|
0.81 pg/mL
Standard Deviation 0.47
|
0.86 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
sVEGF
|
1.93 pg/mL
Standard Deviation 0.42
|
1.85 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
sVCAM-1
|
4.96 pg/mL
Standard Deviation 0.15
|
5.03 pg/mL
Standard Deviation 0.21
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 1
sICAM-1
|
4.66 pg/mL
Standard Deviation 0.12
|
4.74 pg/mL
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-1alpha
|
0.74 pg/mL
Standard Deviation 0.66
|
0.69 pg/mL
Standard Deviation 0.68
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-1beta
|
0.36 pg/mL
Standard Deviation 0.46
|
0.42 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-4
|
0.28 pg/mL
Standard Deviation 0.28
|
0.19 pg/mL
Standard Deviation 0.18
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-6
|
0.68 pg/mL
Standard Deviation 0.55
|
0.78 pg/mL
Standard Deviation 0.45
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-7
|
0.83 pg/mL
Standard Deviation 0.31
|
0.61 pg/mL
Standard Deviation 0.38
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-8
|
1.15 pg/mL
Standard Deviation 0.29
|
1.21 pg/mL
Standard Deviation 0.29
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-10
|
0.21 pg/mL
Standard Deviation 0.23
|
0.32 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-12p70
|
0.34 pg/mL
Standard Deviation 0.32
|
0.34 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-17A
|
0.50 pg/mL
Standard Deviation 0.48
|
0.41 pg/mL
Standard Deviation 0.36
|
|
Blood Cytokine Level at Pre-dose on Day 10
IL-21
|
1.62 pg/mL
Standard Deviation 1.02
|
1.63 pg/mL
Standard Deviation 0.86
|
|
Blood Cytokine Level at Pre-dose on Day 10
IP-10
|
2.01 pg/mL
Standard Deviation 0.25
|
2.18 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at Pre-dose on Day 10
TNFalpha
|
0.48 pg/mL
Standard Deviation 0.49
|
0.48 pg/mL
Standard Deviation 0.50
|
|
Blood Cytokine Level at Pre-dose on Day 10
IFNgamma
|
0.11 pg/mL
Standard Deviation 0.05
|
0.11 pg/mL
Standard Deviation 0.03
|
|
Blood Cytokine Level at Pre-dose on Day 10
G-CSF
|
0.60 pg/mL
Standard Deviation 0.43
|
0.60 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at Pre-dose on Day 10
GM-CSF
|
0.48 pg/mL
Standard Deviation 0.46
|
0.37 pg/mL
Standard Deviation 0.48
|
|
Blood Cytokine Level at Pre-dose on Day 10
MCP1
|
2.17 pg/mL
Standard Deviation 0.34
|
2.09 pg/mL
Standard Deviation 0.38
|
|
Blood Cytokine Level at Pre-dose on Day 10
MIP1a
|
0.83 pg/mL
Standard Deviation 0.52
|
0.89 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at Pre-dose on Day 10
sVEGF
|
1.93 pg/mL
Standard Deviation 0.44
|
1.90 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at Pre-dose on Day 10
sVCAM-1
|
4.90 pg/mL
Standard Deviation 0.16
|
5.03 pg/mL
Standard Deviation 0.16
|
|
Blood Cytokine Level at Pre-dose on Day 10
sICAM-1
|
4.63 pg/mL
Standard Deviation 0.11
|
4.74 pg/mL
Standard Deviation 0.20
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-7
|
0.75 pg/mL
Standard Deviation 0.34
|
0.53 pg/mL
Standard Deviation 0.30
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-8
|
1.19 pg/mL
Standard Deviation 0.36
|
1.14 pg/mL
Standard Deviation 0.32
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-10
|
0.18 pg/mL
Standard Deviation 0.17
|
0.32 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-12p70
|
0.27 pg/mL
Standard Deviation 0.26
|
0.35 pg/mL
Standard Deviation 0.43
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-17A
|
0.49 pg/mL
Standard Deviation 0.47
|
0.37 pg/mL
Standard Deviation 0.37
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-21
|
1.47 pg/mL
Standard Deviation 1.08
|
1.53 pg/mL
Standard Deviation 0.99
|
|
Blood Cytokine Level at Pre-dose on Day 28
IP-10
|
2.01 pg/mL
Standard Deviation 0.19
|
2.24 pg/mL
Standard Deviation 0.40
|
|
Blood Cytokine Level at Pre-dose on Day 28
TNFalpha
|
0.46 pg/mL
Standard Deviation 0.49
|
0.43 pg/mL
Standard Deviation 0.48
|
|
Blood Cytokine Level at Pre-dose on Day 28
IFNgamma
|
0.11 pg/mL
Standard Deviation 0.03
|
0.10 pg/mL
Standard Deviation 0.00
|
|
Blood Cytokine Level at Pre-dose on Day 28
G-CSF
|
0.65 pg/mL
Standard Deviation 0.39
|
0.66 pg/mL
Standard Deviation 0.34
|
|
Blood Cytokine Level at Pre-dose on Day 28
GM-CSF
|
0.48 pg/mL
Standard Deviation 0.48
|
0.35 pg/mL
Standard Deviation 0.45
|
|
Blood Cytokine Level at Pre-dose on Day 28
MCP1
|
2.21 pg/mL
Standard Deviation 0.35
|
2.09 pg/mL
Standard Deviation 0.40
|
|
Blood Cytokine Level at Pre-dose on Day 28
MIP1a
|
0.84 pg/mL
Standard Deviation 0.44
|
0.83 pg/mL
Standard Deviation 0.34
|
|
Blood Cytokine Level at Pre-dose on Day 28
sVEGF
|
1.89 pg/mL
Standard Deviation 0.41
|
1.83 pg/mL
Standard Deviation 0.27
|
|
Blood Cytokine Level at Pre-dose on Day 28
sVCAM-1
|
4.89 pg/mL
Standard Deviation 0.14
|
5.01 pg/mL
Standard Deviation 0.19
|
|
Blood Cytokine Level at Pre-dose on Day 28
sICAM-1
|
4.61 pg/mL
Standard Deviation 0.09
|
4.70 pg/mL
Standard Deviation 0.21
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-1alpha
|
0.69 pg/mL
Standard Deviation 0.71
|
0.68 pg/mL
Standard Deviation 0.68
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-1beta
|
0.41 pg/mL
Standard Deviation 0.45
|
0.39 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-4
|
0.24 pg/mL
Standard Deviation 0.25
|
0.15 pg/mL
Standard Deviation 0.15
|
|
Blood Cytokine Level at Pre-dose on Day 28
IL-6
|
0.64 pg/mL
Standard Deviation 0.42
|
0.78 pg/mL
Standard Deviation 0.32
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-1alpha
|
0.69 pg/mL
Standard Deviation 0.68
|
0.69 pg/mL
Standard Deviation 0.67
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-1beta
|
0.40 pg/mL
Standard Deviation 0.41
|
0.39 pg/mL
Standard Deviation 0.38
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-4
|
0.25 pg/mL
Standard Deviation 0.25
|
0.15 pg/mL
Standard Deviation 0.14
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-6
|
0.67 pg/mL
Standard Deviation 0.52
|
0.77 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-7
|
0.69 pg/mL
Standard Deviation 0.38
|
0.61 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-8
|
1.10 pg/mL
Standard Deviation 0.23
|
1.12 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-10
|
0.18 pg/mL
Standard Deviation 0.16
|
0.33 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-12p70
|
0.33 pg/mL
Standard Deviation 0.28
|
0.36 pg/mL
Standard Deviation 0.44
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-17A
|
0.44 pg/mL
Standard Deviation 0.45
|
0.36 pg/mL
Standard Deviation 0.34
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IL-21
|
1.46 pg/mL
Standard Deviation 1.06
|
1.52 pg/mL
Standard Deviation 0.99
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IP-10
|
2.00 pg/mL
Standard Deviation 0.21
|
2.23 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
TNFalpha
|
0.39 pg/mL
Standard Deviation 0.46
|
0.43 pg/mL
Standard Deviation 0.48
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
IFNgamma
|
0.12 pg/mL
Standard Deviation 0.06
|
0.11 pg/mL
Standard Deviation 0.04
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
G-CSF
|
0.63 pg/mL
Standard Deviation 0.39
|
0.66 pg/mL
Standard Deviation 0.29
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
GM-CSF
|
0.47 pg/mL
Standard Deviation 0.47
|
0.36 pg/mL
Standard Deviation 0.45
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
MCP1
|
2.23 pg/mL
Standard Deviation 0.30
|
2.06 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
MIP1a
|
0.81 pg/mL
Standard Deviation 0.45
|
0.83 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
sVEGF
|
1.85 pg/mL
Standard Deviation 0.38
|
1.81 pg/mL
Standard Deviation 0.26
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
sVCAM-1
|
4.85 pg/mL
Standard Deviation 0.15
|
5.04 pg/mL
Standard Deviation 0.17
|
|
Blood Cytokine Level at 1 Hour Post-dose on Day 28
sICAM-1
|
4.58 pg/mL
Standard Deviation 0.10
|
4.73 pg/mL
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
TNFalpha
|
0.38 pg/mL
Standard Deviation 0.42
|
0.38 pg/mL
Standard Deviation 0.49
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IFNgamma
|
0.12 pg/mL
Standard Deviation 0.07
|
0.11 pg/mL
Standard Deviation 0.04
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-1alpha
|
0.67 pg/mL
Standard Deviation 0.69
|
0.75 pg/mL
Standard Deviation 0.66
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-1beta
|
0.27 pg/mL
Standard Deviation 0.32
|
0.33 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-4
|
0.22 pg/mL
Standard Deviation 0.27
|
0.14 pg/mL
Standard Deviation 0.11
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-6
|
0.56 pg/mL
Standard Deviation 0.30
|
0.69 pg/mL
Standard Deviation 0.29
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-7
|
0.66 pg/mL
Standard Deviation 0.45
|
0.56 pg/mL
Standard Deviation 0.36
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-8
|
1.07 pg/mL
Standard Deviation 0.21
|
1.07 pg/mL
Standard Deviation 0.25
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-10
|
0.16 pg/mL
Standard Deviation 0.13
|
0.28 pg/mL
Standard Deviation 0.32
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-12p70
|
0.26 pg/mL
Standard Deviation 0.27
|
0.31 pg/mL
Standard Deviation 0.44
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-17A
|
0.37 pg/mL
Standard Deviation 0.44
|
0.34 pg/mL
Standard Deviation 0.37
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IL-21
|
1.51 pg/mL
Standard Deviation 1.05
|
1.68 pg/mL
Standard Deviation 0.92
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
IP-10
|
1.89 pg/mL
Standard Deviation 0.21
|
2.13 pg/mL
Standard Deviation 0.36
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
G-CSF
|
0.57 pg/mL
Standard Deviation 0.43
|
0.72 pg/mL
Standard Deviation 0.26
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
GM-CSF
|
0.49 pg/mL
Standard Deviation 0.47
|
0.38 pg/mL
Standard Deviation 0.46
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
MCP1
|
2.09 pg/mL
Standard Deviation 0.23
|
1.99 pg/mL
Standard Deviation 0.38
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
MIP1a
|
0.71 pg/mL
Standard Deviation 0.48
|
0.80 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
sVEGF
|
1.80 pg/mL
Standard Deviation 0.36
|
1.84 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
sVCAM-1
|
4.91 pg/mL
Standard Deviation 0.15
|
5.00 pg/mL
Standard Deviation 0.14
|
|
Blood Cytokine Level at 4 Hours Post-dose on Day 28
sICAM-1
|
4.61 pg/mL
Standard Deviation 0.09
|
4.71 pg/mL
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-6
|
0.71 pg/mL
Standard Deviation 0.39
|
0.79 pg/mL
Standard Deviation 0.34
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-17A
|
0.44 pg/mL
Standard Deviation 0.42
|
0.29 pg/mL
Standard Deviation 0.36
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-21
|
1.58 pg/mL
Standard Deviation 1.04
|
1.30 pg/mL
Standard Deviation 1.13
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-1alpha
|
0.76 pg/mL
Standard Deviation 0.68
|
0.63 pg/mL
Standard Deviation 0.69
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-1beta
|
0.29 pg/mL
Standard Deviation 0.35
|
0.34 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-4
|
0.23 pg/mL
Standard Deviation 0.27
|
0.14 pg/mL
Standard Deviation 0.12
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-7
|
0.67 pg/mL
Standard Deviation 0.40
|
0.66 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-8
|
1.10 pg/mL
Standard Deviation 0.21
|
1.17 pg/mL
Standard Deviation 0.26
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-10
|
0.15 pg/mL
Standard Deviation 0.11
|
0.29 pg/mL
Standard Deviation 0.30
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IL-12p70
|
0.28 pg/mL
Standard Deviation 0.28
|
0.33 pg/mL
Standard Deviation 0.42
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IP-10
|
1.85 pg/mL
Standard Deviation 0.22
|
2.14 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
TNFalpha
|
0.36 pg/mL
Standard Deviation 0.43
|
0.35 pg/mL
Standard Deviation 0.48
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
IFNgamma
|
0.10 pg/mL
Standard Deviation 0.00
|
0.12 pg/mL
Standard Deviation 0.07
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
G-CSF
|
0.65 pg/mL
Standard Deviation 0.37
|
0.83 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
GM-CSF
|
0.48 pg/mL
Standard Deviation 0.45
|
0.38 pg/mL
Standard Deviation 0.46
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
MCP1
|
2.11 pg/mL
Standard Deviation 0.31
|
2.02 pg/mL
Standard Deviation 0.40
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
MIP1a
|
0.71 pg/mL
Standard Deviation 0.45
|
0.71 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
sVEGF
|
1.71 pg/mL
Standard Deviation 0.36
|
1.82 pg/mL
Standard Deviation 0.25
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
sVCAM-1
|
4.87 pg/mL
Standard Deviation 0.16
|
5.05 pg/mL
Standard Deviation 0.15
|
|
Blood Cytokine Level at 8 Hours Post-dose on Day 28
sICAM-1
|
4.59 pg/mL
Standard Deviation 0.09
|
4.74 pg/mL
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-1alpha
|
0.73 pg/mL
Standard Deviation 0.66
|
0.66 pg/mL
Standard Deviation 0.64
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-1beta
|
0.38 pg/mL
Standard Deviation 0.41
|
0.38 pg/mL
Standard Deviation 0.41
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-4
|
0.26 pg/mL
Standard Deviation 0.27
|
0.15 pg/mL
Standard Deviation 0.15
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-6
|
0.93 pg/mL
Standard Deviation 0.42
|
0.99 pg/mL
Standard Deviation 0.47
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-7
|
0.79 pg/mL
Standard Deviation 0.35
|
0.64 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-8
|
1.21 pg/mL
Standard Deviation 0.32
|
1.18 pg/mL
Standard Deviation 0.29
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-10
|
0.22 pg/mL
Standard Deviation 0.17
|
0.30 pg/mL
Standard Deviation 0.33
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-12p70
|
0.25 pg/mL
Standard Deviation 0.25
|
0.37 pg/mL
Standard Deviation 0.44
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-17A
|
0.44 pg/mL
Standard Deviation 0.44
|
0.32 pg/mL
Standard Deviation 0.32
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IL-21
|
1.54 pg/mL
Standard Deviation 0.98
|
1.64 pg/mL
Standard Deviation 0.87
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IP-10
|
2.02 pg/mL
Standard Deviation 0.31
|
2.27 pg/mL
Standard Deviation 0.39
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
TNFalpha
|
0.42 pg/mL
Standard Deviation 0.47
|
0.42 pg/mL
Standard Deviation 0.51
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
IFNgamma
|
0.16 pg/mL
Standard Deviation 0.19
|
0.10 pg/mL
Standard Deviation 0.00
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
G-CSF
|
0.67 pg/mL
Standard Deviation 0.39
|
0.71 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
GM-CSF
|
0.46 pg/mL
Standard Deviation 0.46
|
0.31 pg/mL
Standard Deviation 0.44
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
MCP1
|
2.33 pg/mL
Standard Deviation 0.24
|
2.10 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
MIP1a
|
0.86 pg/mL
Standard Deviation 0.49
|
0.88 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
sVEGF
|
1.89 pg/mL
Standard Deviation 0.41
|
1.84 pg/mL
Standard Deviation 0.23
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
sVCAM-1
|
4.88 pg/mL
Standard Deviation 0.14
|
5.06 pg/mL
Standard Deviation 0.17
|
|
Blood Cytokine Level at 24 Hours Post-dose on Day 28
sICAM-1
|
4.58 pg/mL
Standard Deviation 0.10
|
4.74 pg/mL
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were collected from all the participants and pro-inflammatory cytokine levels were measured. The levels of pro-inflammatory cytokine IL-1beta, IL-1alpha, IL-4, IL-6, IL-8, IL-10, IL-17A, IL-7, IL-21, IL-12p70, IP-10, TNFalpha, IFNgamma, GM-CSF, MIP1a, MCP1, sVEGF, sVCAM-1, sICAM-1, G-CSF was measured by immunoassay and the levels were expresses as pg/mL.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-1alpha
|
0.70 pg/mL
Standard Deviation 0.68
|
0.66 pg/mL
Standard Deviation 0.66
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-1beta
|
0.43 pg/mL
Standard Deviation 0.43
|
0.38 pg/mL
Standard Deviation 0.41
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-4
|
0.29 pg/mL
Standard Deviation 0.31
|
0.14 pg/mL
Standard Deviation 0.13
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-6
|
0.81 pg/mL
Standard Deviation 0.46
|
0.66 pg/mL
Standard Deviation 0.44
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-7
|
0.85 pg/mL
Standard Deviation 0.31
|
0.52 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-8
|
1.08 pg/mL
Standard Deviation 0.26
|
1.04 pg/mL
Standard Deviation 0.23
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-10
|
0.22 pg/mL
Standard Deviation 0.17
|
0.34 pg/mL
Standard Deviation 0.37
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-12p70
|
0.32 pg/mL
Standard Deviation 0.26
|
0.33 pg/mL
Standard Deviation 0.45
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-17A
|
0.43 pg/mL
Standard Deviation 0.48
|
0.36 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IL-21
|
1.41 pg/mL
Standard Deviation 1.04
|
1.58 pg/mL
Standard Deviation 0.99
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IP-10
|
2.20 pg/mL
Standard Deviation 0.27
|
2.28 pg/mL
Standard Deviation 0.38
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
TNFalpha
|
0.46 pg/mL
Standard Deviation 0.48
|
0.43 pg/mL
Standard Deviation 0.51
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
IFNgamma
|
0.17 pg/mL
Standard Deviation 0.22
|
0.10 pg/mL
Standard Deviation 0.00
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
G-CSF
|
0.57 pg/mL
Standard Deviation 0.55
|
0.58 pg/mL
Standard Deviation 0.28
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
GM-CSF
|
0.45 pg/mL
Standard Deviation 0.46
|
0.35 pg/mL
Standard Deviation 0.42
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
MCP1
|
2.17 pg/mL
Standard Deviation 0.26
|
2.07 pg/mL
Standard Deviation 0.35
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
MIP1a
|
0.82 pg/mL
Standard Deviation 0.50
|
0.85 pg/mL
Standard Deviation 0.31
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
sVEGF
|
1.92 pg/mL
Standard Deviation 0.42
|
1.88 pg/mL
Standard Deviation 0.29
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
sVCAM-1
|
4.97 pg/mL
Standard Deviation 0.13
|
5.05 pg/mL
Standard Deviation 0.16
|
|
Blood Cytokine Level at Pre-dose on Day 35 or Early Termination
sICAM-1
|
4.65 pg/mL
Standard Deviation 0.12
|
4.76 pg/mL
Standard Deviation 0.15
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for fluorescence-activated cell sorting \[FACS\] analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, Bone-marrow cells (B cells) and natural killer (NK) cells were analyzed using fluorescent-labeled antibodies against clusters of differentiation (CD) markers.
Outcome measures
| Measure |
CP-690,550
n=11 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
B Cells (CD19)
|
214.09 cells per microliter (cells/mcL)
Standard Deviation 134.72
|
389.17 cells per microliter (cells/mcL)
Standard Deviation 190.27
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Total T Cells (CD3)
|
1516.27 cells per microliter (cells/mcL)
Standard Deviation 567.38
|
1579.00 cells per microliter (cells/mcL)
Standard Deviation 628.89
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD8 T Cells (CD3 CD8)
|
402.73 cells per microliter (cells/mcL)
Standard Deviation 205.74
|
376.67 cells per microliter (cells/mcL)
Standard Deviation 189.14
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD4 T Cells (CD3 CD4)
|
1114.82 cells per microliter (cells/mcL)
Standard Deviation 415.59
|
1199.17 cells per microliter (cells/mcL)
Standard Deviation 496.66
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
NK Cells (CD16 CD56)
|
276.45 cells per microliter (cells/mcL)
Standard Deviation 134.62
|
190.67 cells per microliter (cells/mcL)
Standard Deviation 121.20
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Immature B Cells
|
10.27 cells per microliter (cells/mcL)
Standard Deviation 11.23
|
8.83 cells per microliter (cells/mcL)
Standard Deviation 5.65
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Naive Cells
|
165.64 cells per microliter (cells/mcL)
Standard Deviation 113.99
|
273.67 cells per microliter (cells/mcL)
Standard Deviation 178.51
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Marginal B Cells
|
17.55 cells per microliter (cells/mcL)
Standard Deviation 7.62
|
81.50 cells per microliter (cells/mcL)
Standard Deviation 168.29
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Memory B Cells
|
20.45 cells per microliter (cells/mcL)
Standard Deviation 12.36
|
25.00 cells per microliter (cells/mcL)
Standard Deviation 14.83
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Central Memory CD4 Cells
|
627.45 cells per microliter (cells/mcL)
Standard Deviation 306.86
|
673.33 cells per microliter (cells/mcL)
Standard Deviation 291.75
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Effector Memory CD4 Cells
|
130.09 cells per microliter (cells/mcL)
Standard Deviation 138.98
|
93.92 cells per microliter (cells/mcL)
Standard Deviation 97.30
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Naive CD4 Cells
|
311.09 cells per microliter (cells/mcL)
Standard Deviation 245.67
|
420.92 cells per microliter (cells/mcL)
Standard Deviation 294.76
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Terminally Differentiated(Diff) EffectorCD4 Cells
|
45.82 cells per microliter (cells/mcL)
Standard Deviation 83.60
|
10.25 cells per microliter (cells/mcL)
Standard Deviation 15.15
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Central Memory CD8 Cells
|
117.73 cells per microliter (cells/mcL)
Standard Deviation 102.47
|
136.58 cells per microliter (cells/mcL)
Standard Deviation 77.79
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Effector Memory CD8 Cells
|
38.55 cells per microliter (cells/mcL)
Standard Deviation 29.88
|
68.25 cells per microliter (cells/mcL)
Standard Deviation 88.65
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Naive CD8 Cells
|
111.91 cells per microliter (cells/mcL)
Standard Deviation 81.86
|
113.08 cells per microliter (cells/mcL)
Standard Deviation 50.56
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
Terminally Diff Effector Memory CD8 Cells
|
134.36 cells per microliter (cells/mcL)
Standard Deviation 140.97
|
58.83 cells per microliter (cells/mcL)
Standard Deviation 52.87
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD4 T-Cells
|
81.91 cells per microliter (cells/mcL)
Standard Deviation 34.76
|
81.92 cells per microliter (cells/mcL)
Standard Deviation 42.95
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD56 Bright NK-Cells
|
9.27 cells per microliter (cells/mcL)
Standard Deviation 3.85
|
7.00 cells per microliter (cells/mcL)
Standard Deviation 4.13
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD56 Dim NK-Cell
|
209.09 cells per microliter (cells/mcL)
Standard Deviation 124.61
|
143.83 cells per microliter (cells/mcL)
Standard Deviation 103.97
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD56 Null NK-Cells
|
57.82 cells per microliter (cells/mcL)
Standard Deviation 61.05
|
39.58 cells per microliter (cells/mcL)
Standard Deviation 27.28
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 1
CD56 Dim Null NK-Cells
|
266.73 cells per microliter (cells/mcL)
Standard Deviation 132.17
|
183.42 cells per microliter (cells/mcL)
Standard Deviation 118.39
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
B Cells (CD19)
|
207.07 cells/mcL
Standard Deviation 128.57
|
312.69 cells/mcL
Standard Deviation 216.36
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Total T Cells (CD3)
|
1533.53 cells/mcL
Standard Deviation 631.42
|
1596.54 cells/mcL
Standard Deviation 754.87
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD8 T Cells (CD3 CD8)
|
431.07 cells/mcL
Standard Deviation 229.21
|
372.38 cells/mcL
Standard Deviation 157.96
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD4 T Cells (CD3 CD4)
|
1102.60 cells/mcL
Standard Deviation 450.53
|
1208.08 cells/mcL
Standard Deviation 651.25
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
NK Cells (CD16 CD56)
|
422.87 cells/mcL
Standard Deviation 182.11
|
179.15 cells/mcL
Standard Deviation 107.03
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Immature B Cells
|
8.40 cells/mcL
Standard Deviation 9.63
|
8.92 cells/mcL
Standard Deviation 7.49
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Naive Cells
|
166.60 cells/mcL
Standard Deviation 111.95
|
222.75 cells/mcL
Standard Deviation 185.92
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Marginal B Cells
|
16.20 cells/mcL
Standard Deviation 6.65
|
78.17 cells/mcL
Standard Deviation 151.67
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Memory B Cells
|
16.07 cells/mcL
Standard Deviation 8.04
|
25.75 cells/mcL
Standard Deviation 17.78
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Central Memory CD4 Cells
|
640.07 cells/mcL
Standard Deviation 314.78
|
706.42 cells/mcL
Standard Deviation 360.34
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Effector Memory CD4 Cells
|
121.07 cells/mcL
Standard Deviation 127.98
|
61.83 cells/mcL
Standard Deviation 45.05
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Naive CD4 Cells
|
298.47 cells/mcL
Standard Deviation 197.32
|
459.75 cells/mcL
Standard Deviation 382.27
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Terminally Diff Effector CD4 Cells
|
42.93 cells/mcL
Standard Deviation 87.65
|
4.50 cells/mcL
Standard Deviation 6.78
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Central Memory CD8 Cells
|
134.40 cells/mcL
Standard Deviation 102.91
|
141.75 cells/mcL
Standard Deviation 87.65
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Effector Memory CD8 Cells
|
49.00 cells/mcL
Standard Deviation 37.44
|
46.58 cells/mcL
Standard Deviation 64.47
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Naive CD8 Cells
|
114.20 cells/mcL
Standard Deviation 50.74
|
137.33 cells/mcL
Standard Deviation 69.67
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
Terminally Diff Effector Memory CD8 Cells
|
133.53 cells/mcL
Standard Deviation 168.92
|
39.58 cells/mcL
Standard Deviation 36.34
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD4 T-Cells
|
76.13 cells/mcL
Standard Deviation 39.65
|
91.92 cells/mcL
Standard Deviation 55.68
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD56 Bright NK-Cells
|
10.00 cells/mcL
Standard Deviation 4.75
|
7.23 cells/mcL
Standard Deviation 4.38
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD56 Dim NK-Cell
|
358.33 cells/mcL
Standard Deviation 171.65
|
136.92 cells/mcL
Standard Deviation 97.23
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD56 Null NK-Cells
|
54.40 cells/mcL
Standard Deviation 44.65
|
34.77 cells/mcL
Standard Deviation 23.81
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 1
CD56 Dim Null NK-Cells
|
412.60 cells/mcL
Standard Deviation 180.18
|
171.62 cells/mcL
Standard Deviation 104.39
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
B Cells (CD19)
|
222.79 cells/mcL
Standard Deviation 154.52
|
380.33 cells/mcL
Standard Deviation 220.41
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Total T Cells (CD3)
|
1841.07 cells/mcL
Standard Deviation 880.14
|
1710.42 cells/mcL
Standard Deviation 959.80
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD8 T Cells (CD3 CD8)
|
505.64 cells/mcL
Standard Deviation 298.97
|
393.00 cells/mcL
Standard Deviation 205.06
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD4 T Cells (CD3 CD4)
|
1338.79 cells/mcL
Standard Deviation 633.15
|
1312.92 cells/mcL
Standard Deviation 834.04
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
NK Cells (CD16 CD56)
|
428.50 cells/mcL
Standard Deviation 207.39
|
201.83 cells/mcL
Standard Deviation 192.98
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Immature B Cells
|
8.29 cells/mcL
Standard Deviation 10.41
|
10.92 cells/mcL
Standard Deviation 10.09
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Naive Cells
|
177.50 cells/mcL
Standard Deviation 129.90
|
265.00 cells/mcL
Standard Deviation 209.57
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Marginal B Cells
|
19.86 cells/mcL
Standard Deviation 12.60
|
74.83 cells/mcL
Standard Deviation 129.24
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Memory B Cells
|
17.07 cells/mcL
Standard Deviation 10.98
|
29.17 cells/mcL
Standard Deviation 23.94
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Central Memory CD4 Cells
|
785.43 cells/mcL
Standard Deviation 388.64
|
720.50 cells/mcL
Standard Deviation 383.62
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Effector Memory CD4 Cells
|
155.71 cells/mcL
Standard Deviation 165.49
|
93.42 cells/mcL
Standard Deviation 129.36
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Naive CD4 Cells
|
352.43 cells/mcL
Standard Deviation 307.49
|
488.75 cells/mcL
Standard Deviation 499.88
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Terminally Diff Effector CD4 Cells
|
45.57 cells/mcL
Standard Deviation 103.39
|
10.42 cells/mcL
Standard Deviation 18.37
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Central Memory CD8 Cells
|
159.21 cells/mcL
Standard Deviation 119.89
|
140.42 cells/mcL
Standard Deviation 90.69
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Effector Memory CD8 Cells
|
64.07 cells/mcL
Standard Deviation 52.87
|
61.33 cells/mcL
Standard Deviation 104.75
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Naive CD8 Cells
|
127.71 cells/mcL
Standard Deviation 54.79
|
142.42 cells/mcL
Standard Deviation 69.46
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
Terminally Diff Effector Memory CD8 Cells
|
154.43 cells/mcL
Standard Deviation 201.13
|
48.67 cells/mcL
Standard Deviation 58.85
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD4 T-Cells
|
86.36 cells/mcL
Standard Deviation 42.89
|
97.83 cells/mcL
Standard Deviation 78.84
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD56 Bright NK-Cells
|
11.21 cells/mcL
Standard Deviation 6.05
|
7.17 cells/mcL
Standard Deviation 3.95
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD56 Dim NK-Cell
|
364.57 cells/mcL
Standard Deviation 191.50
|
157.17 cells/mcL
Standard Deviation 158.85
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD56 Null NK-Cells
|
52.57 cells/mcL
Standard Deviation 48.32
|
37.33 cells/mcL
Standard Deviation 37.57
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 1
CD56 Dim Null NK-Cells
|
417.00 cells/mcL
Standard Deviation 204.21
|
194.50 cells/mcL
Standard Deviation 191.68
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
B Cells (CD19)
|
290.50 cells/mcL
Standard Deviation 144.94
|
310.92 cells/mcL
Standard Deviation 154.13
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Total T Cells (CD3)
|
1732.29 cells/mcL
Standard Deviation 581.98
|
1477.08 cells/mcL
Standard Deviation 696.45
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD8 T Cells (CD3 CD8)
|
413.64 cells/mcL
Standard Deviation 169.81
|
384.15 cells/mcL
Standard Deviation 216.57
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD4 T Cells (CD3 CD4)
|
1314.64 cells/mcL
Standard Deviation 475.64
|
1084.62 cells/mcL
Standard Deviation 547.23
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
NK Cells (CD16 CD56)
|
258.79 cells/mcL
Standard Deviation 177.98
|
205.38 cells/mcL
Standard Deviation 138.20
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Immature B Cells
|
11.21 cells/mcL
Standard Deviation 9.96
|
8.85 cells/mcL
Standard Deviation 7.99
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Naive Cells
|
218.57 cells/mcL
Standard Deviation 121.71
|
211.38 cells/mcL
Standard Deviation 133.45
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Marginal B Cells
|
32.29 cells/mcL
Standard Deviation 20.28
|
69.23 cells/mcL
Standard Deviation 135.70
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Memory B Cells
|
28.50 cells/mcL
Standard Deviation 14.53
|
21.31 cells/mcL
Standard Deviation 13.01
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Central Memory CD4 Cells
|
696.21 cells/mcL
Standard Deviation 294.16
|
603.54 cells/mcL
Standard Deviation 300.56
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Effector Memory CD4 Cells
|
130.86 cells/mcL
Standard Deviation 139.79
|
78.92 cells/mcL
Standard Deviation 102.26
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Naive CD4 Cells
|
453.86 cells/mcL
Standard Deviation 314.82
|
393.08 cells/mcL
Standard Deviation 296.88
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Terminally Diff Effector CD4 Cells
|
33.43 cells/mcL
Standard Deviation 52.47
|
9.31 cells/mcL
Standard Deviation 18.40
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Central Memory CD8 Cells
|
126.71 cells/mcL
Standard Deviation 95.74
|
132.46 cells/mcL
Standard Deviation 76.09
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Effector Memory CD8 Cells
|
37.57 cells/mcL
Standard Deviation 27.11
|
69.38 cells/mcL
Standard Deviation 104.84
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Naive CD8 Cells
|
136.93 cells/mcL
Standard Deviation 66.75
|
122.54 cells/mcL
Standard Deviation 91.92
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
Terminally Diff Effector Memory CD8 Cells
|
112.50 cells/mcL
Standard Deviation 114.14
|
59.77 cells/mcL
Standard Deviation 70.15
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD4 T-Cells
|
93.64 cells/mcL
Standard Deviation 57.44
|
79.69 cells/mcL
Standard Deviation 43.04
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD56 Bright NK-Cells
|
5.07 cells/mcL
Standard Deviation 2.37
|
8.23 cells/mcL
Standard Deviation 4.80
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD56 Dim NK-Cell
|
207.50 cells/mcL
Standard Deviation 162.82
|
149.54 cells/mcL
Standard Deviation 115.63
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD56 Null NK-Cells
|
46.29 cells/mcL
Standard Deviation 52.45
|
47.46 cells/mcL
Standard Deviation 35.83
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 10
CD56 Dim Null NK-Cells
|
253.64 cells/mcL
Standard Deviation 176.82
|
196.92 cells/mcL
Standard Deviation 136.36
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
B Cells (CD19)
|
399.62 cells/mcL
Standard Deviation 208.61
|
392.25 cells/mcL
Standard Deviation 235.63
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Total T Cells(CD3)
|
1730.38 cells/mcL
Standard Deviation 730.18
|
1451.92 cells/mcL
Standard Deviation 622.86
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD8 T Cells (CD3 CD8)
|
363.85 cells/mcL
Standard Deviation 143.45
|
346.58 cells/mcL
Standard Deviation 206.22
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD4 T Cells (CD3 CD4)
|
1352.46 cells/mcL
Standard Deviation 618.78
|
1102.08 cells/mcL
Standard Deviation 454.72
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
NK Cells (CD16 CD56)
|
184.92 cells/mcL
Standard Deviation 103.73
|
180.33 cells/mcL
Standard Deviation 123.31
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Immature B Cells
|
13.85 cells/mcL
Standard Deviation 8.99
|
11.25 cells/mcL
Standard Deviation 11.86
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Naive Cells
|
304.77 cells/mcL
Standard Deviation 177.06
|
280.50 cells/mcL
Standard Deviation 212.30
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Marginal B Cells
|
44.31 cells/mcL
Standard Deviation 36.38
|
73.75 cells/mcL
Standard Deviation 159.25
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Memory B Cells
|
36.69 cells/mcL
Standard Deviation 18.14
|
26.50 cells/mcL
Standard Deviation 19.50
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Central Memory CD4 Cells
|
736.00 cells/mcL
Standard Deviation 272.68
|
623.67 cells/mcL
Standard Deviation 259.72
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Effector Memory CD4 Cells
|
118.54 cells/mcL
Standard Deviation 91.20
|
90.00 cells/mcL
Standard Deviation 98.80
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Naive CD4 Cells
|
475.23 cells/mcL
Standard Deviation 421.51
|
378.50 cells/mcL
Standard Deviation 193.71
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Terminally Diff Effector CD4 Cells
|
22.69 cells/mcL
Standard Deviation 28.46
|
9.50 cells/mcL
Standard Deviation 14.13
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Central Memory CD8 Cells
|
120.69 cells/mcL
Standard Deviation 65.03
|
120.50 cells/mcL
Standard Deviation 68.09
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Effector Memory CD8 Cells
|
32.92 cells/mcL
Standard Deviation 25.69
|
55.50 cells/mcL
Standard Deviation 67.08
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Naive CD8 Cells
|
131.38 cells/mcL
Standard Deviation 85.53
|
121.75 cells/mcL
Standard Deviation 86.96
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
Terminally Diff Effector Memory CD8 Cells
|
78.46 cells/mcL
Standard Deviation 81.53
|
49.00 cells/mcL
Standard Deviation 61.65
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD4 T-Cells
|
84.38 cells/mcL
Standard Deviation 54.71
|
75.08 cells/mcL
Standard Deviation 43.97
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD56 Bright NK-Cells
|
4.15 cells/mcL
Standard Deviation 2.03
|
7.17 cells/mcL
Standard Deviation 4.41
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD56 Dim NK-Cell
|
127.15 cells/mcL
Standard Deviation 78.63
|
134.25 cells/mcL
Standard Deviation 103.99
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD56 Null NK-Cells
|
53.77 cells/mcL
Standard Deviation 51.21
|
38.83 cells/mcL
Standard Deviation 35.54
|
|
Blood T, B and NK Lymphocyte Counts at Pre-dose on Day 28
CD56 Dim Null NK-Cells
|
180.77 cells/mcL
Standard Deviation 103.02
|
173.17 cells/mcL
Standard Deviation 119.76
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
B Cells (CD19)
|
343.21 cells/mcL
Standard Deviation 159.97
|
329.00 cells/mcL
Standard Deviation 202.97
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Total T Cells(CD3)
|
1705.57 cells/mcL
Standard Deviation 621.55
|
1630.64 cells/mcL
Standard Deviation 816.41
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD8 T Cells (CD3 CD8)
|
409.71 cells/mcL
Standard Deviation 158.79
|
482.07 cells/mcL
Standard Deviation 388.11
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD4 T Cells (CD3 CD4)
|
1281.00 cells/mcL
Standard Deviation 491.92
|
1145.50 cells/mcL
Standard Deviation 522.79
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
NK Cells (CD16 CD56)
|
309.43 cells/mcL
Standard Deviation 112.95
|
339.50 cells/mcL
Standard Deviation 426.91
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Immature B Cells
|
12.43 cells/mcL
Standard Deviation 7.84
|
9.14 cells/mcL
Standard Deviation 9.04
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Naive Cells
|
261.57 cells/mcL
Standard Deviation 140.28
|
233.86 cells/mcL
Standard Deviation 171.68
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Marginal B Cells
|
36.43 cells/mcL
Standard Deviation 20.14
|
63.00 cells/mcL
Standard Deviation 141.24
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Memory B Cells
|
32.57 cells/mcL
Standard Deviation 15.27
|
23.07 cells/mcL
Standard Deviation 17.84
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Central Memory CD4 Cells
|
723.43 cells/mcL
Standard Deviation 253.15
|
614.50 cells/mcL
Standard Deviation 219.76
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Effector Memory CD4 Cells
|
117.21 cells/mcL
Standard Deviation 99.96
|
143.14 cells/mcL
Standard Deviation 237.16
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Naive CD4 Cells
|
418.93 cells/mcL
Standard Deviation 321.41
|
370.43 cells/mcL
Standard Deviation 199.66
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Terminally Diff Effector CD4 Cells
|
21.07 cells/mcL
Standard Deviation 31.32
|
17.43 cells/mcL
Standard Deviation 36.50
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Central Memory CD8 Cells
|
141.50 cells/mcL
Standard Deviation 82.12
|
128.14 cells/mcL
Standard Deviation 70.76
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Effector Memory CD8 Cells
|
36.07 cells/mcL
Standard Deviation 23.82
|
114.79 cells/mcL
Standard Deviation 187.14
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Naive CD8 Cells
|
135.29 cells/mcL
Standard Deviation 83.65
|
140.07 cells/mcL
Standard Deviation 101.82
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
Terminally Diff Effector Memory CD8 Cells
|
97.21 cells/mcL
Standard Deviation 109.27
|
98.93 cells/mcL
Standard Deviation 154.16
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD4 T-Cells
|
88.50 cells/mcL
Standard Deviation 51.93
|
78.64 cells/mcL
Standard Deviation 41.50
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD56 Bright NK-Cells
|
4.71 cells/mcL
Standard Deviation 2.43
|
8.14 cells/mcL
Standard Deviation 5.53
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD56 Dim NK-Cell
|
258.43 cells/mcL
Standard Deviation 111.98
|
284.14 cells/mcL
Standard Deviation 394.73
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD56 Null NK-Cells
|
46.29 cells/mcL
Standard Deviation 25.38
|
46.93 cells/mcL
Standard Deviation 52.57
|
|
Blood T, B and NK Lymphocyte Counts at 1 Hour Post-dose on Day 28
CD56 Dim Null NK-Cells
|
304.64 cells/mcL
Standard Deviation 112.88
|
331.14 cells/mcL
Standard Deviation 422.93
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=11 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
B Cells (CD19)
|
336.45 cells/mcL
Standard Deviation 194.70
|
347.67 cells/mcL
Standard Deviation 233.30
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Total T Cells(CD3)
|
1483.00 cells/mcL
Standard Deviation 495.98
|
1445.83 cells/mcL
Standard Deviation 712.35
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD8 T Cells (CD3 CD8)
|
355.27 cells/mcL
Standard Deviation 111.71
|
346.00 cells/mcL
Standard Deviation 209.68
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD4 T Cells (CD3 CD4)
|
1122.91 cells/mcL
Standard Deviation 419.02
|
1095.00 cells/mcL
Standard Deviation 565.70
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
NK Cells (CD16 CD56)
|
188.36 cells/mcL
Standard Deviation 59.25
|
200.75 cells/mcL
Standard Deviation 191.26
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Immature B Cells
|
10.73 cells/mcL
Standard Deviation 8.33
|
10.33 cells/mcL
Standard Deviation 10.82
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Naive Cells
|
256.91 cells/mcL
Standard Deviation 156.81
|
247.17 cells/mcL
Standard Deviation 207.69
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Marginal B Cells
|
38.73 cells/mcL
Standard Deviation 38.69
|
67.17 cells/mcL
Standard Deviation 129.67
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Memory B Cells
|
29.91 cells/mcL
Standard Deviation 17.27
|
23.17 cells/mcL
Standard Deviation 19.64
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Central Memory CD4 Cells
|
675.55 cells/mcL
Standard Deviation 270.78
|
631.50 cells/mcL
Standard Deviation 260.76
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Effector Memory CD4 Cells
|
110.09 cells/mcL
Standard Deviation 69.34
|
85.92 cells/mcL
Standard Deviation 134.06
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Naive CD4 Cells
|
312.00 cells/mcL
Standard Deviation 237.45
|
369.50 cells/mcL
Standard Deviation 314.06
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Terminally Diff Effector CD4 Cells
|
24.91 cells/mcL
Standard Deviation 30.27
|
8.17 cells/mcL
Standard Deviation 20.56
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Central Memory CD8 Cells
|
118.09 cells/mcL
Standard Deviation 78.61
|
112.83 cells/mcL
Standard Deviation 60.76
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Effector Memory CD8 Cells
|
37.09 cells/mcL
Standard Deviation 27.50
|
60.17 cells/mcL
Standard Deviation 91.98
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Naive CD8 Cells
|
126.00 cells/mcL
Standard Deviation 90.18
|
133.17 cells/mcL
Standard Deviation 98.02
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
Terminally Diff Effector Memory CD8 Cells
|
73.91 cells/mcL
Standard Deviation 58.79
|
40.00 cells/mcL
Standard Deviation 75.37
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD4 T-Cells
|
64.09 cells/mcL
Standard Deviation 33.05
|
65.36 cells/mcL
Standard Deviation 36.70
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD56 Bright NK-Cells
|
4.55 cells/mcL
Standard Deviation 2.42
|
6.83 cells/mcL
Standard Deviation 4.71
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD56 Dim NK-Cell
|
143.55 cells/mcL
Standard Deviation 49.57
|
163.50 cells/mcL
Standard Deviation 158.10
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD56 Null NK-Cells
|
40.36 cells/mcL
Standard Deviation 25.74
|
30.50 cells/mcL
Standard Deviation 35.48
|
|
Blood T, B and NK Lymphocyte Counts at 4 Hours Post-dose on Day 28
CD56 Dim Null NK-Cells
|
183.64 cells/mcL
Standard Deviation 58.53
|
193.92 cells/mcL
Standard Deviation 188.21
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=12 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=11 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
B Cells (CD19)
|
382.33 cells/mcL
Standard Deviation 204.55
|
318.27 cells/mcL
Standard Deviation 253.87
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Total T Cells(CD3)
|
1557.58 cells/mcL
Standard Deviation 601.36
|
1616.00 cells/mcL
Standard Deviation 934.75
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD8 T Cells (CD3 CD8)
|
348.33 cells/mcL
Standard Deviation 135.33
|
420.18 cells/mcL
Standard Deviation 226.60
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD4 T Cells (CD3 CD4)
|
1203.67 cells/mcL
Standard Deviation 491.02
|
1186.73 cells/mcL
Standard Deviation 788.19
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
NK Cells (CD16 CD56)
|
174.58 cells/mcL
Standard Deviation 82.07
|
217.91 cells/mcL
Standard Deviation 148.22
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Immature B Cells
|
11.25 cells/mcL
Standard Deviation 7.10
|
7.30 cells/mcL
Standard Deviation 8.08
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Naive Cells
|
291.33 cells/mcL
Standard Deviation 165.84
|
243.10 cells/mcL
Standard Deviation 220.30
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Marginal B Cells
|
46.50 cells/mcL
Standard Deviation 38.57
|
76.60 cells/mcL
Standard Deviation 142.34
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Memory B Cells
|
33.00 cells/mcL
Standard Deviation 20.82
|
22.70 cells/mcL
Standard Deviation 19.96
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Central Memory CD4 Cells
|
726.75 cells/mcL
Standard Deviation 293.12
|
725.00 cells/mcL
Standard Deviation 424.16
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Effector Memory CD4 Cells
|
119.17 cells/mcL
Standard Deviation 87.92
|
85.64 cells/mcL
Standard Deviation 127.90
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Naive CD4 Cells
|
338.17 cells/mcL
Standard Deviation 270.26
|
367.73 cells/mcL
Standard Deviation 378.39
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Terminally Diff Effector CD4 Cells
|
19.83 cells/mcL
Standard Deviation 21.41
|
8.27 cells/mcL
Standard Deviation 18.79
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Central Memory CD8 Cells
|
115.92 cells/mcL
Standard Deviation 51.47
|
149.27 cells/mcL
Standard Deviation 86.30
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Effector Memory CD8 Cells
|
35.33 cells/mcL
Standard Deviation 25.27
|
85.09 cells/mcL
Standard Deviation 110.75
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Naive CD8 Cells
|
133.25 cells/mcL
Standard Deviation 95.54
|
133.64 cells/mcL
Standard Deviation 111.11
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
Terminally Diff Effector Memory CD8 Cells
|
64.08 cells/mcL
Standard Deviation 56.47
|
52.27 cells/mcL
Standard Deviation 72.48
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD4 T-Cells
|
79.00 cells/mcL
Standard Deviation 53.92
|
89.50 cells/mcL
Standard Deviation 72.98
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD56 Bright NK-Cells
|
3.36 cells/mcL
Standard Deviation 1.80
|
7.27 cells/mcL
Standard Deviation 4.29
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD56 Dim NK-Cell
|
117.18 cells/mcL
Standard Deviation 59.33
|
164.36 cells/mcL
Standard Deviation 125.72
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD56 Null NK-Cells
|
41.91 cells/mcL
Standard Deviation 29.36
|
46.27 cells/mcL
Standard Deviation 38.40
|
|
Blood T, B and NK Lymphocyte Counts at 8 Hours Post-dose on Day 28
CD56 Dim Null NK-Cells
|
158.91 cells/mcL
Standard Deviation 74.78
|
210.64 cells/mcL
Standard Deviation 145.85
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=12 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
B Cells (CD19)
|
276.00 cells/mcL
Standard Deviation 167.25
|
300.92 cells/mcL
Standard Deviation 191.57
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Total T Cells(CD3)
|
1044.08 cells/mcL
Standard Deviation 505.60
|
1619.33 cells/mcL
Standard Deviation 913.77
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD8 T Cells (CD3 CD8)
|
239.92 cells/mcL
Standard Deviation 113.32
|
382.75 cells/mcL
Standard Deviation 200.38
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD4 T Cells (CD3 CD4)
|
799.50 cells/mcL
Standard Deviation 408.07
|
1223.17 cells/mcL
Standard Deviation 779.67
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
NK Cells (CD16 CD56)
|
92.92 cells/mcL
Standard Deviation 52.30
|
196.67 cells/mcL
Standard Deviation 152.83
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Immature B Cells
|
10.00 cells/mcL
Standard Deviation 4.20
|
9.75 cells/mcL
Standard Deviation 9.52
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Naive Cells
|
215.83 cells/mcL
Standard Deviation 146.07
|
245.33 cells/mcL
Standard Deviation 173.16
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Marginal B Cells
|
25.58 cells/mcL
Standard Deviation 18.78
|
24.08 cells/mcL
Standard Deviation 27.05
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Memory B Cells
|
24.83 cells/mcL
Standard Deviation 11.10
|
21.75 cells/mcL
Standard Deviation 16.10
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Central Memory CD4 Cells
|
431.92 cells/mcL
Standard Deviation 186.89
|
626.00 cells/mcL
Standard Deviation 339.12
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Effector Memory CD4 Cells
|
59.58 cells/mcL
Standard Deviation 41.84
|
79.50 cells/mcL
Standard Deviation 119.68
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Naive CD4 Cells
|
297.17 cells/mcL
Standard Deviation 287.44
|
508.83 cells/mcL
Standard Deviation 483.29
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Terminally Diff Effector CD4 Cells
|
11.00 cells/mcL
Standard Deviation 18.39
|
9.00 cells/mcL
Standard Deviation 18.01
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Central Memory CD8 Cells
|
85.50 cells/mcL
Standard Deviation 72.10
|
133.33 cells/mcL
Standard Deviation 83.39
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Effector Memory CD8 Cells
|
16.75 cells/mcL
Standard Deviation 8.58
|
59.17 cells/mcL
Standard Deviation 93.93
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Naive CD8 Cells
|
89.25 cells/mcL
Standard Deviation 62.57
|
142.08 cells/mcL
Standard Deviation 131.13
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
Terminally Diff Effector Memory CD8 Cells
|
48.42 cells/mcL
Standard Deviation 55.68
|
48.17 cells/mcL
Standard Deviation 60.46
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD4 T Cells
|
61.67 cells/mcL
Standard Deviation 41.32
|
92.58 cells/mcL
Standard Deviation 59.44
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD56 Bright NK-Cells
|
1.83 cells/mcL
Standard Deviation 1.11
|
8.50 cells/mcL
Standard Deviation 4.76
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD56 Dim NK-Cell
|
65.42 cells/mcL
Standard Deviation 47.76
|
158.17 cells/mcL
Standard Deviation 137.82
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD56 Null NK-Cells
|
25.50 cells/mcL
Standard Deviation 12.72
|
30.08 cells/mcL
Standard Deviation 26.57
|
|
Blood T, B and NK Lymphocyte Counts at 24 Hours Post-dose on Day 28
CD56 Dim Null NK-Cells
|
91.08 cells/mcL
Standard Deviation 51.61
|
187.92 cells/mcL
Standard Deviation 149.63
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were collected for FACS analysis of lymphocyte subsets. Lymphocyte subset counts of T cells, B cells and NK cells were analyzed using fluorescent-labeled antibodies against CD markers.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD4 T Cells
|
66.64 cells/mcL
Standard Deviation 40.58
|
73.50 cells/mcL
Standard Deviation 39.02
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
B Cells (CD19)
|
173.86 cells/mcL
Standard Deviation 95.29
|
344.17 cells/mcL
Standard Deviation 211.00
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Total T Cells (CD3)
|
1044.07 cells/mcL
Standard Deviation 529.37
|
1411.75 cells/mcL
Standard Deviation 474.97
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD8 T Cells (CD3+CD8)
|
253.64 cells/mcL
Standard Deviation 190.57
|
364.92 cells/mcL
Standard Deviation 202.70
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD4 T Cells (CD3 CD4)
|
781.57 cells/mcL
Standard Deviation 350.40
|
1046.00 cells/mcL
Standard Deviation 328.08
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
NK Cells (CD16 CD56)
|
162.21 cells/mcL
Standard Deviation 116.20
|
179.67 cells/mcL
Standard Deviation 142.64
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Immature B Cells
|
5.57 cells/mcL
Standard Deviation 3.59
|
11.17 cells/mcL
Standard Deviation 9.99
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Naive Cells
|
136.43 cells/mcL
Standard Deviation 80.37
|
252.92 cells/mcL
Standard Deviation 206.67
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Marginal B Cells
|
15.50 cells/mcL
Standard Deviation 8.72
|
57.58 cells/mcL
Standard Deviation 102.20
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Memory B Cells
|
16.36 cells/mcL
Standard Deviation 12.73
|
22.50 cells/mcL
Standard Deviation 13.93
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Central Memory CD4 Cells
|
416.93 cells/mcL
Standard Deviation 167.72
|
605.00 cells/mcL
Standard Deviation 222.14
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Effector Memory CD4 Cells
|
56.29 cells/mcL
Standard Deviation 51.24
|
97.25 cells/mcL
Standard Deviation 103.24
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Naive CD4 Cells
|
290.36 cells/mcL
Standard Deviation 244.79
|
333.83 cells/mcL
Standard Deviation 132.59
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Terminally Diff Effector CD4 Cells
|
18.00 cells/mcL
Standard Deviation 24.88
|
9.75 cells/mcL
Standard Deviation 16.44
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Central Memory CD8 Cells
|
73.71 cells/mcL
Standard Deviation 58.46
|
109.42 cells/mcL
Standard Deviation 49.90
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Effector Memory CD8 Cells
|
17.93 cells/mcL
Standard Deviation 13.74
|
70.58 cells/mcL
Standard Deviation 99.36
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Naive CD8 Cells
|
101.79 cells/mcL
Standard Deviation 126.51
|
133.75 cells/mcL
Standard Deviation 97.93
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
Terminally Diff Effector Memory CD8 Cells
|
60.07 cells/mcL
Standard Deviation 67.10
|
51.08 cells/mcL
Standard Deviation 61.27
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD56 Bright NK-Cells
|
3.62 cells/mcL
Standard Deviation 2.60
|
6.33 cells/mcL
Standard Deviation 3.52
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD56 Dim NK-Cell
|
99.00 cells/mcL
Standard Deviation 89.92
|
141.17 cells/mcL
Standard Deviation 130.25
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD56 Null NK-Cells
|
66.23 cells/mcL
Standard Deviation 72.59
|
32.25 cells/mcL
Standard Deviation 19.30
|
|
Blood T, B and NK Lymphocyte Counts and Possible Subsets at Pre-dose on Day 35 or Early Termination
CD56 Dim Null NK-Cells
|
165.15 cells/mcL
Standard Deviation 115.88
|
173.25 cells/mcL
Standard Deviation 141.06
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific Enzyme-Linked Immunosorbent Assay \[ELISA\] method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples).
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1
MMP3
|
38.31 nanogram per milliliter (ng/mL)
Standard Deviation 32.24
|
24.52 nanogram per milliliter (ng/mL)
Standard Deviation 12.65
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1
Osteocalcin
|
19.54 nanogram per milliliter (ng/mL)
Standard Deviation 8.23
|
18.54 nanogram per milliliter (ng/mL)
Standard Deviation 12.31
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 1
Osteopontin
|
108.40 nanogram per milliliter (ng/mL)
Standard Deviation 42.59
|
98.11 nanogram per milliliter (ng/mL)
Standard Deviation 37.04
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1
MMP3
|
37.30 ng/mL
Standard Deviation 32.40
|
22.42 ng/mL
Standard Deviation 12.06
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1
Osteocalcin
|
18.90 ng/mL
Standard Deviation 8.12
|
18.01 ng/mL
Standard Deviation 11.38
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 1
Osteopontin
|
101.10 ng/mL
Standard Deviation 40.23
|
94.37 ng/mL
Standard Deviation 39.02
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1
MMP3
|
36.98 ng/mL
Standard Deviation 30.72
|
22.09 ng/mL
Standard Deviation 12.08
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1
Osteocalcin
|
18.17 ng/mL
Standard Deviation 7.30
|
19.01 ng/mL
Standard Deviation 13.17
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 1
Osteopontin
|
99.82 ng/mL
Standard Deviation 36.77
|
95.23 ng/mL
Standard Deviation 38.37
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10
MMP3
|
32.10 ng/mL
Standard Deviation 26.89
|
21.05 ng/mL
Standard Deviation 12.28
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10
Osteocalcin
|
21.35 ng/mL
Standard Deviation 8.87
|
18.60 ng/mL
Standard Deviation 11.28
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 10
Osteopontin
|
91.13 ng/mL
Standard Deviation 29.16
|
91.12 ng/mL
Standard Deviation 34.13
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28
MMP3
|
25.18 ng/mL
Standard Deviation 22.33
|
19.26 ng/mL
Standard Deviation 11.64
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28
Osteocalcin
|
22.05 ng/mL
Standard Deviation 9.28
|
16.51 ng/mL
Standard Deviation 9.06
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 28
Osteopontin
|
78.23 ng/mL
Standard Deviation 17.23
|
79.93 ng/mL
Standard Deviation 18.63
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28
MMP3
|
21.59 ng/mL
Standard Deviation 19.30
|
18.86 ng/mL
Standard Deviation 11.73
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28
Osteocalcin
|
21.45 ng/mL
Standard Deviation 9.65
|
17.37 ng/mL
Standard Deviation 8.85
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 1 Hour Post-dose on Day 28
Osteopontin
|
78.60 ng/mL
Standard Deviation 19.24
|
86.66 ng/mL
Standard Deviation 29.65
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28
Osteocalcin
|
21.09 ng/mL
Standard Deviation 8.26
|
15.45 ng/mL
Standard Deviation 7.22
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28
MMP3
|
19.71 ng/mL
Standard Deviation 17.65
|
16.67 ng/mL
Standard Deviation 10.70
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 4 Hours Post-dose on Day 28
Osteopontin
|
71.52 ng/mL
Standard Deviation 24.92
|
86.56 ng/mL
Standard Deviation 33.00
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28
MMP3
|
17.94 ng/mL
Standard Deviation 14.38
|
16.68 ng/mL
Standard Deviation 11.75
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28
Osteocalcin
|
20.93 ng/mL
Standard Deviation 6.37
|
16.67 ng/mL
Standard Deviation 8.63
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 8 Hours Post-dose on Day 28
Osteopontin
|
75.32 ng/mL
Standard Deviation 21.32
|
89.84 ng/mL
Standard Deviation 33.02
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28
MMP3
|
24.48 ng/mL
Standard Deviation 20.82
|
26.20 ng/mL
Standard Deviation 15.56
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28
Osteocalcin
|
20.96 ng/mL
Standard Deviation 9.45
|
17.49 ng/mL
Standard Deviation 9.57
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at 24 Hours Post-dose on Day 28
Osteopontin
|
82.60 ng/mL
Standard Deviation 22.28
|
95.51 ng/mL
Standard Deviation 28.50
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood/serum samples were analyzed for MMP3, osteocalcin and osteopontin concentrations using a validated analytical assay sensitive and specific ELISA method for MMP3 and osteopontin in serum samples; specific electrochemiluminescence method for osteocalcin in blood samples.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination
MMP3
|
28.98 ng/mL
Standard Deviation 21.36
|
28.72 ng/mL
Standard Deviation 24.48
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination
Osteocalcin
|
21.79 ng/mL
Standard Deviation 9.38
|
16.60 ng/mL
Standard Deviation 10.48
|
|
Matrix Metallopeptidase 3 (MMP3), Osteocalcin and Osteopontin Levels at Pre-dose on Day 35 or Early Termination
Osteopontin
|
95.93 ng/mL
Standard Deviation 29.73
|
86.48 ng/mL
Standard Deviation 29.69
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at Pre-dose on Day 1
|
38.40 pg/mL
Standard Deviation 17.44
|
33.32 pg/mL
Standard Deviation 5.80
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 1
|
33.89 pg/mL
Standard Deviation 13.44
|
31.48 pg/mL
Standard Deviation 8.77
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 1
|
32.97 pg/mL
Standard Deviation 13.31
|
33.35 pg/mL
Standard Deviation 7.12
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at Pre-dose on Day 10
|
34.93 pg/mL
Standard Deviation 11.76
|
31.48 pg/mL
Standard Deviation 8.37
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at Pre-dose on Day 28
|
38.46 pg/mL
Standard Deviation 12.64
|
33.39 pg/mL
Standard Deviation 8.94
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at 1 Hour Post-dose on Day 28
|
37.97 pg/mL
Standard Deviation 14.05
|
33.93 pg/mL
Standard Deviation 7.51
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at 4 Hours Post-dose on Day 28
|
38.70 pg/mL
Standard Deviation 13.25
|
36.65 pg/mL
Standard Deviation 12.54
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=11 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at 8 Hours Post-dose on Day 28
|
37.76 pg/mL
Standard Deviation 15.90
|
37.82 pg/mL
Standard Deviation 18.84
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at 24 Hours Post-dose on Day 28
|
35.91 pg/mL
Standard Deviation 19.94
|
36.08 pg/mL
Standard Deviation 10.17
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
Plasma samples were analyzed for PTH concentrations using a validated, sensitive and specific electrochemiluminescence method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Parathyroid Hormone (PTH) Level at Pre-dose on Day 35 or Early Termination
|
37.30 pg/mL
Standard Deviation 14.86
|
34.59 pg/mL
Standard Deviation 10.40
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at Pre-dose on Day 1
|
5.99 picomole per liter (pmol/L)
Standard Deviation 2.04
|
6.21 picomole per liter (pmol/L)
Standard Deviation 1.91
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 1
|
6.13 pmol/L
Standard Deviation 1.99
|
5.72 pmol/L
Standard Deviation 2.16
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 1
|
5.50 picomole per liter (pmol/L)
Standard Deviation 1.53
|
5.35 picomole per liter (pmol/L)
Standard Deviation 1.86
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at Pre-dose on Day 10
|
6.02 pmol/L
Standard Deviation 1.88
|
5.82 pmol/L
Standard Deviation 2.22
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at Pre-dose on Day 28
|
5.53 pmol/L
Standard Deviation 1.79
|
5.64 pmol/L
Standard Deviation 2.48
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at 1 Hour Post-dose on Day 28
|
5.72 pmol/L
Standard Deviation 1.86
|
5.56 pmol/L
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at 4 Hours Post-dose on Day 28
|
5.18 pmol/L
Standard Deviation 1.55
|
5.69 pmol/L
Standard Deviation 2.13
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at 8 Hours Post-dose on Day 28
|
4.64 pmol/L
Standard Deviation 1.28
|
5.64 pmol/L
Standard Deviation 2.39
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin (OPG) Level at 24 Hours Post-dose on Day 28
|
7.22 pmol/L
Standard Deviation 2.74
|
6.20 pmol/L
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
Blood samples were analyzed for OPG concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Osteoprotegerin(OPG) Level at Pre-dose on Day 35 or Early Termination
|
6.31 pmol/L
Standard Deviation 1.70
|
5.65 pmol/L
Standard Deviation 2.01
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28Population: Analyses of MMP13 was not performed as valid assay for MMP13 was not available.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose on Day 1, 10, 28 and 35 or Early Termination; 1, 4 hours Post-dose on Day 1, 28; 8, 24 hours Post-dose on Day 28Population: Analyses of IL-34 and IL-18 were not performed as a valid assay was not available.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.
Serum samples were analyzed for SAA concentrations using meso scale discovery (MSD) single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific Electro ChemiLuminescent ImmunoAssay (ECLIA).
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1
SAA (n=14, 14)
|
26383.03 ng/mL
Standard Deviation 43196.37
|
23427.00 ng/mL
Standard Deviation 43431.26
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 1
CTX-1 (n=14, 12)
|
0.43 ng/mL
Standard Deviation 0.26
|
0.37 ng/mL
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1
SAA
|
25716.93 ng/mL
Standard Deviation 42986.70
|
23308.57 ng/mL
Standard Deviation 41911.51
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 1
CTX-1
|
0.36 ng/mL
Standard Deviation 0.25
|
0.32 ng/mL
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1
SAA
|
26460.26 ng/mL
Standard Deviation 46059.64
|
27297.36 ng/mL
Standard Deviation 52346.36
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 1
CTX-1
|
0.25 ng/mL
Standard Deviation 0.12
|
0.25 ng/mL
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10
SAA
|
5968.89 ng/mL
Standard Deviation 5509.18
|
31666.50 ng/mL
Standard Deviation 92833.52
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 10
CTX-1
|
0.34 ng/mL
Standard Deviation 0.16
|
0.35 ng/mL
Standard Deviation 0.22
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28
SAA
|
4094.94 ng/mL
Standard Deviation 2527.72
|
14818.88 ng/mL
Standard Deviation 18346.19
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 28
CTX-1
|
0.36 ng/mL
Standard Deviation 0.19
|
0.35 ng/mL
Standard Deviation 0.19
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28
SAA
|
3921.49 ng/mL
Standard Deviation 2291.33
|
18976.74 ng/mL
Standard Deviation 29228.65
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 1 Hour Post-dose on Day 28
CTX-1
|
0.32 ng/mL
Standard Deviation 0.16
|
0.35 ng/mL
Standard Deviation 0.25
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28
SAA
|
4042.21 ng/mL
Standard Deviation 2974.03
|
20123.97 ng/mL
Standard Deviation 31463.56
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 4 Hours Post-dose on Day 28
CTX-1
|
0.29 ng/mL
Standard Deviation 0.17
|
0.20 ng/mL
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28
SAA (n=14, 12)
|
4113.05 ng/mL
Standard Deviation 2939.86
|
15403.08 ng/mL
Standard Deviation 24616.14
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 8 Hours Post-dose on Day 28
CTX-1 (n=12, 12)
|
0.28 ng/mL
Standard Deviation 0.17
|
0.31 ng/mL
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28
SAA
|
6643.14 ng/mL
Standard Deviation 6504.55
|
14627.28 ng/mL
Standard Deviation 16685.62
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at 24 Hours Post-dose on Day 28
CTX-1
|
0.28 ng/mL
Standard Deviation 0.16
|
0.28 ng/mL
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
Serum samples were analyzed for SAA concentrations using MSD single ELISA electrochemiluminescence method and for CTX-1 concentrations using a validated, sensitive and specific ECLIA.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination
SAA
|
22174.19 ng/mL
Standard Deviation 25387.79
|
33853.61 ng/mL
Standard Deviation 88542.43
|
|
Serum Amyloid A (SAA) and Carboxy-Terminal Collagen Crosslinks-1 (CTX-1) Levels at Pre-dose on Day 35 or Early Termination
CTX-1
|
0.27 ng/mL
Standard Deviation 0.15
|
0.34 ng/mL
Standard Deviation 0.16
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1
IL-1ra
|
545.71 pg/mL
Standard Deviation 279.48
|
449.38 pg/mL
Standard Deviation 163.85
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 1
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1
IL-1ra
|
565.43 pg/mL
Standard Deviation 262.73
|
479.93 pg/mL
Standard Deviation 167.61
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 1
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1
IL-1ra
|
518.29 pg/mL
Standard Deviation 297.33
|
477.25 pg/mL
Standard Deviation 142.17
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 1
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10
IL-1ra
|
487.00 pg/mL
Standard Deviation 265.16
|
465.00 pg/mL
Standard Deviation 176.17
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 10
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28
IL-1ra
|
437.73 pg/mL
Standard Deviation 171.93
|
617.38 pg/mL
Standard Deviation 624.81
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 28
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 1 Hour Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28
IL-1ra
|
421.00 pg/mL
Standard Deviation 196.57
|
501.31 pg/mL
Standard Deviation 337.85
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 1 Hour Post-dose on Day 28
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 4 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28
IL-1ra (n= 13, 13)
|
388.15 pg/mL
Standard Deviation 147.27
|
552.85 pg/mL
Standard Deviation 415.32
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 4 Hours Post-dose on Day 28
IL-15 (n=11, 12)
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 8 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points for each arm group, respectively.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=12 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=12 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28
IL-1ra (n=12, 12)
|
399.08 pg/mL
Standard Deviation 157.84
|
414.67 pg/mL
Standard Deviation 152.99
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 8 Hours Post-dose on Day 28
IL-15 (n=12, 10)
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28
IL-1ra
|
500.38 pg/mL
Standard Deviation 187.55
|
462.57 pg/mL
Standard Deviation 175.80
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at 24 Hours Post-dose on Day 28
IL-15
|
8.26 pg/mL
Standard Deviation 0.94
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
Serum samples were analyzed for IL-1ra and IL-15 concentrations using a validated, sensitive and specific ELISA method.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination
IL-1ra
|
520.87 pg/mL
Standard Deviation 282.88
|
486.57 pg/mL
Standard Deviation 317.27
|
|
Interleukin-1 Receptor Antagonist (IL-1ra) and Interleukin-15 (IL-15) Levels at Pre-dose on Day 35 or Early Termination
IL-15
|
8.00 pg/mL
Standard Deviation 0.00
|
8.00 pg/mL
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Pre-dose on Day 1Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as nanogram per millimoles of creatinine (ng/mmol Cr).
Outcome measures
| Measure |
CP-690,550
n=13 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 1
|
454.74 ng/mmol Cr
Standard Deviation 216.74
|
345.87 ng/mmol Cr
Standard Deviation 259.83
|
PRIMARY outcome
Timeframe: Pre-dose on Day 10Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 10
|
318.10 ng/mmol Cr
Standard Deviation 208.07
|
423.76 ng/mmol Cr
Standard Deviation 389.15
|
PRIMARY outcome
Timeframe: Pre-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication.
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 28
|
320.42 ng/mmol Cr
Standard Deviation 192.31
|
409.89 ng/mmol Cr
Standard Deviation 338.67
|
PRIMARY outcome
Timeframe: 24 Hours Post-dose on Day 28Population: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=13 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at 24 Hours Post-dose on Day 28
|
267.86 ng/mmol Cr
Standard Deviation 159.63
|
284.87 ng/mmol Cr
Standard Deviation 202.92
|
PRIMARY outcome
Timeframe: Pre-dose on Day 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication. Here, 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Urinary concentration of collagen type II C-telopeptide fragments was measured by competitive ELISA. uCTX-II was measured as ng/mmol Cr.
Outcome measures
| Measure |
CP-690,550
n=14 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Urine Collagen Type II C-telopeptide Fragments (uCTX-II) at Pre-dose on Day 35 or Early Termination
|
278.55 ng/mmol Cr
Standard Deviation 198.90
|
340.83 ng/mmol Cr
Standard Deviation 379.42
|
SECONDARY outcome
Timeframe: Day 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% Response
Day 28
|
60.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20% Response
Day 35 or Early Termination
|
33.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
ACR50 response: \>=50% improvement in TJC; \>= 50% improvement in SJC; and 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Day 28
|
40.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Day 35 or Early Termination
|
13.3 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
ACR70 response: \>=70% improvement in TJC; \>= 70% improvement in SJC; and 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Day 28
|
6.7 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Day 35 or Early Termination
|
6.7 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day -7, 1 (Baseline), 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP) (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6 implied remission.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Day -7
|
5.58 units on a scale
Standard Deviation 0.87
|
5.06 units on a scale
Standard Deviation 1.16
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Day 1 (Baseline)
|
5.57 units on a scale
Standard Deviation 0.78
|
5.22 units on a scale
Standard Deviation 0.96
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Day 28
|
4.06 units on a scale
Standard Deviation 0.97
|
4.91 units on a scale
Standard Deviation 0.92
|
|
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Day 35 or Early Termination
|
4.91 units on a scale
Standard Deviation 1.10
|
4.79 units on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35
Day 28
|
-1.51 units on a scale
Standard Deviation 0.97
|
-0.31 units on a scale
Standard Deviation 0.49
|
|
Change From Baseline in Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 28 and 35
Day 35 or Early Termination
|
-0.66 units on a scale
Standard Deviation 0.96
|
-0.43 units on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: Day -7, 1 (Baseline), 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
DAS28-3 (CRP) was calculated from the SJC, TJC using the 28 joints count and the CRP (mg/mL). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) \<= 3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day 28: DAS28-3 (CRP) <=3.2
|
20.0 percentage of participants
|
14.3 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day -7: DAS28-3 (CRP) <=3.2
|
0.0 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day -7: DAS28-3 (CRP) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day 1 (Baseline): DAS28-3 (CRP) <=3.2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day 1 (Baseline): DAS28-3 (CRP) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day 28: DAS28-3 (CRP) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day 35 or Early Termination: DAS28-3 (CRP) <=3.2
|
6.7 percentage of participants
|
7.1 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) <=3.2 and <2.6
Day 35 or Early Termination: DAS28-3 (CRP) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day -7, 1 (Baseline), 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Day -7
|
6.60 units on a scale
Standard Deviation 0.98
|
6.17 units on a scale
Standard Deviation 1.12
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Day 1 (Baseline)
|
6.55 units on a scale
Standard Deviation 0.98
|
6.32 units on a scale
Standard Deviation 1.01
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Day 28
|
4.90 units on a scale
Standard Deviation 1.11
|
6.03 units on a scale
Standard Deviation 0.98
|
|
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Day 35 or Early Termination
|
5.83 units on a scale
Standard Deviation 1.23
|
6.00 units on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Day 1 (Baseline), 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR \[mm/hour\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35
Day 28
|
-1.58 units on a scale
Standard Deviation 1.02
|
-0.30 units on a scale
Standard Deviation 0.60
|
|
Change From Baseline in Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Day 28 and 35
Day 35 or Early Termination
|
-0.73 units on a scale
Standard Deviation 0.91
|
-0.32 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Day -7, 1 (Baseline), 28, 35 or Early TerminationPopulation: FAS included all randomized participants who received at least 1 dose of the study medication.
DAS28-4 (ESR) was calculated from the number of SJC, TJC using the 28 joints count, ESR \[mm/hour\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity, \> 3.2 to 5.1 implied moderate to high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
CP-690,550
n=15 Participants
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 Participants
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day -7: DAS28-4 (ESR) =<3.2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day -7: DAS28-4 (ESR) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day 1 (Baseline): DAS28-4 (ESR) =<3.2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day 1 (Baseline): DAS28-4 (ESR) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day 28: DAS28-4 (ESR) =<3.2
|
7.1 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day 28: DAS28-4 (ESR) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day 35 or Early Termination: DAS28-4 (ESR) =<3.2
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) <=3.2 and <2.6
Day 35 or Early Termination: DAS28-4 (ESR) <2.6
|
0.0 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
CP-690,550
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CP-690,550
n=15 participants at risk
CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
Placebo
n=14 participants at risk
Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
13.3%
2/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Folliculitis
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood creatinine increased
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
13.3%
2/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.7%
1/15
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER