Trial Outcomes & Findings for A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088) (NCT NCT00746512)
NCT ID: NCT00746512
Last Updated: 2015-05-29
Results Overview
Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
45 participants
Primary outcome timeframe
Baseline and Day 14
Results posted on
2015-05-29
Participant Flow
Participant milestones
| Measure |
Prednisone 15 mg
Prednisone 15 mg tablets once daily for 15 days
|
Placebo 15 mg
Prednisone 15 mg placebo tablets once daily for 15 days
|
Prednisone 7.5 mg
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Placebo 7.5 mg
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
18
|
9
|
|
Overall Study
COMPLETED
|
8
|
10
|
18
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)
Baseline characteristics by cohort
| Measure |
Prednisone 15 mg
n=8 Participants
Prednisone 15 mg tablets once daily for 15 days
|
Placebo 15 mg
n=10 Participants
Prednisone 15 mg placebo tablets once daily for 15 days
|
Prednisone 7.5 mg
n=18 Participants
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Placebo 7.5 mg
n=9 Participants
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
n=99 Participants
|
58.4 years
n=107 Participants
|
57.9 years
n=206 Participants
|
55.1 years
n=7 Participants
|
58.1 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
29 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 14Synovial Blood Flow was measured as the 2-dimensional quantitative Transverse Power Doppler Area summed over each of the 10 metacarpophalangeal joints (10MCP 2D Trans PDA). The PDA is a count of the number of pixels with power Doppler signal, uncorrected by pixel intensity, within an expert drawn region of interest encompassing the synovium and excluding digital vessels in a standardized 2D transverse image of the joint. A higher pixel count relates to greater synovial blood flow. A decrease in pixel count relates to a reduction in synovial blood flow.
Outcome measures
| Measure |
Prednisone 15 mg
n=8 Participants
Prednisone 15 mg tablets once daily for 15 days
|
Placebo 15 mg
n=10 Participants
Prednisone 15 mg placebo tablets once daily for 15 days
|
Prednisone 7.5 mg
n=18 Participants
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Placebo 7.5 mg
n=9 Participants
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
|---|---|---|---|---|
|
Synovial Blood Flow
Baseline
|
9.48 pixel count
Standard Deviation 6.44
|
10.55 pixel count
Standard Deviation 9.54
|
8.31 pixel count
Standard Deviation 8.66
|
9.78 pixel count
Standard Deviation 7.28
|
|
Synovial Blood Flow
Day 14
|
6.52 pixel count
Standard Deviation 6.40
|
13.37 pixel count
Standard Deviation 11.05
|
4.44 pixel count
Standard Deviation 4.94
|
9.15 pixel count
Standard Deviation 11.65
|
|
Synovial Blood Flow
Change from Baseline at Day 14
|
-2.96 pixel count
Standard Deviation 5.07
|
2.82 pixel count
Standard Deviation 4.62
|
-3.88 pixel count
Standard Deviation 5.71
|
-0.64 pixel count
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline and Day 14The DAS28(CRP) is a measure of disease activity with components which include the tender joint count (TJC) \& swollen joint count (SJC) (each out of 28 joints counted), a Global Health (GH) index (100 mm visual analog scale \[VAS\]), and the CRP (in mg/L measured from lab test). The scoring formula was: DAS28(CRP) = 0.56\*SQR(TJC28) + 0.28\*SQR(SJC28) + 0.36\*ln(CRP+1) + 0.014\*GH(VAS) + 0.96. Where SQR is square root and ln is natural log. The formula produces a score from 0 to 10: \>5.1 means high disease activity; \<3.2 means low disease activity, \<2.6 is generally considered remission.
Outcome measures
| Measure |
Prednisone 15 mg
n=8 Participants
Prednisone 15 mg tablets once daily for 15 days
|
Placebo 15 mg
n=10 Participants
Prednisone 15 mg placebo tablets once daily for 15 days
|
Prednisone 7.5 mg
n=18 Participants
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Placebo 7.5 mg
n=9 Participants
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
|---|---|---|---|---|
|
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
Day 14
|
3.57 score on scale
Standard Deviation 1.50
|
5.04 score on scale
Standard Deviation 2.09
|
4.57 score on scale
Standard Deviation 1.12
|
5.38 score on scale
Standard Deviation 1.60
|
|
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
Baseline
|
5.17 score on scale
Standard Deviation 1.30
|
5.45 score on scale
Standard Deviation 1.65
|
5.31 score on scale
Standard Deviation 1.18
|
5.62 score on scale
Standard Deviation 1.78
|
|
Disease Activity Score 28 (DAS28) (C-reactive Protein [CRP])
Change from Baseline at Day 14
|
-1.61 score on scale
Standard Deviation 1.69
|
-0.41 score on scale
Standard Deviation 0.72
|
-0.74 score on scale
Standard Deviation 0.86
|
-0.23 score on scale
Standard Deviation 0.83
|
Adverse Events
Prednisone 15 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo 15 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Prednisone 7.5 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo 7.5 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prednisone 15 mg
n=8 participants at risk
Prednisone 15 mg tablets once daily for 15 days
|
Placebo 15 mg
n=10 participants at risk
Prednisone 15 mg placebo tablets once daily for 15 days
|
Prednisone 7.5 mg
n=18 participants at risk
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Placebo 7.5 mg
n=9 participants at risk
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/18
|
11.1%
1/9
|
Other adverse events
| Measure |
Prednisone 15 mg
n=8 participants at risk
Prednisone 15 mg tablets once daily for 15 days
|
Placebo 15 mg
n=10 participants at risk
Prednisone 15 mg placebo tablets once daily for 15 days
|
Prednisone 7.5 mg
n=18 participants at risk
Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
Placebo 7.5 mg
n=9 participants at risk
Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days
As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
20.0%
2/10
|
11.1%
2/18
|
0.00%
0/9
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8
|
0.00%
0/10
|
0.00%
0/18
|
11.1%
1/9
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Infections and infestations
Laryngitis
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Arthalgia
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/18
|
11.1%
1/9
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
0.00%
0/10
|
5.6%
1/18
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pumonary Disease
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/8
|
0.00%
0/10
|
11.1%
2/18
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
12.5%
1/8
|
0.00%
0/10
|
0.00%
0/18
|
0.00%
0/9
|
|
Vascular disorders
Hot Flush
|
0.00%
0/8
|
10.0%
1/10
|
0.00%
0/18
|
0.00%
0/9
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER