Trial Outcomes & Findings for An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy (NCT NCT01592292)
NCT ID: NCT01592292
Last Updated: 2016-08-22
Results Overview
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
COMPLETED
90 participants
Baseline and Month 6
2016-08-22
Participant Flow
The arm Other anti-TNF agent consisting of participants treated with adalimumab, etanercept and infliximab was divided into individual treatment groups only for the purpose of Participant flow reporting. All other analyses were performed in Rituximab versus Other anti-TNF agent.
Participant milestones
| Measure |
Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent: Adalimumab
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent: Etanercept
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent: Infliximab
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
20
|
13
|
11
|
|
Overall Study
Intention to Treat (ITT) Set
|
34
|
13
|
10
|
8
|
|
Overall Study
Standard Population Set (SPS)
|
31
|
10
|
7
|
7
|
|
Overall Study
COMPLETED
|
40
|
15
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
3
|
1
|
Reasons for withdrawal
| Measure |
Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent: Adalimumab
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent: Etanercept
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent: Infliximab
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|---|---|
|
Overall Study
Follow-up loss
|
3
|
3
|
1
|
0
|
|
Overall Study
Withdrew consent
|
2
|
1
|
0
|
0
|
|
Overall Study
Other
|
1
|
1
|
2
|
1
|
Baseline Characteristics
An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
Baseline characteristics by cohort
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
70-79 years
|
2 participants
n=99 Participants
|
5 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Age, Customized
20-29 years
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Age, Customized
30-39 years
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Age, Customized
40-49 years
|
7 participants
n=99 Participants
|
7 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Age, Customized
50-59 years
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Age, Customized
60-69 years
|
15 participants
n=99 Participants
|
6 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Change at Month 6
|
-1.89 units on a scale
Standard Deviation 1.73
|
-1.80 units on a scale
Standard Deviation 1.53
|
|
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Baseline
|
6.35 units on a scale
Standard Deviation 1.14
|
5.54 units on a scale
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Rituximab
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Baseline
|
6.30 units on a scale
Standard Deviation 1.18
|
5.47 units on a scale
Standard Deviation 1.04
|
|
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Change at Month 6
|
-1.74 units on a scale
Standard Deviation 1.59
|
-1.91 units on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point.
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Rituximab
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=17 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in DAS28 at Month 12
Baseline (n=24, 17)
|
6.28 units on a scale
Standard Deviation 1.27
|
5.49 units on a scale
Standard Deviation 0.92
|
|
Efficacy: Mean Change From Baseline in DAS28 at Month 12
Change at Month 12 (n=22, 16)
|
-2.30 units on a scale
Standard Deviation 1.52
|
-2.29 units on a scale
Standard Deviation 1.36
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Outcome measures
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Baseline (n=34, 31)
|
13.38 number of tender joints
Standard Deviation 7.22
|
8.81 number of tender joints
Standard Deviation 6.88
|
|
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 6 (n=34, 31)
|
-8.21 number of tender joints
Standard Deviation 7.54
|
-6.32 number of tender joints
Standard Deviation 7.06
|
|
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 12 (n=29, 24)
|
-9.48 number of tender joints
Standard Deviation 7.02
|
-5.96 number of tender joints
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Outcome measures
| Measure |
Rituximab
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Baseline (n=31, 24)
|
12.87 number of tender joints
Standard Deviation 7.32
|
7.79 number of tender joints
Standard Deviation 5.99
|
|
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 6 (n=31, 24)
|
-7.68 number of tender joints
Standard Deviation 7.55
|
-5.79 number of tender joints
Standard Deviation 6.17
|
|
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 6 (n=26, 20)
|
-8.62 number of tender joints
Standard Deviation 6.89
|
-5.80 number of tender joints
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Outcome measures
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Baseline (n=34, 31)
|
11.24 number of swollen joints
Standard Deviation 6.78
|
7.52 number of swollen joints
Standard Deviation 6.63
|
|
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 6 (n=34, 31)
|
-7.00 number of swollen joints
Standard Deviation 6.86
|
-5.10 number of swollen joints
Standard Deviation 6.48
|
|
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 12 (n-29, 24)
|
-8.62 number of swollen joints
Standard Deviation 6.52
|
-4.29 number of swollen joints
Standard Deviation 5.81
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Outcome measures
| Measure |
Rituximab
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Baseline (n=31, 24)
|
11.16 number of swollen joints
Standard Deviation 7.10
|
7.13 number of swollen joints
Standard Deviation 6.15
|
|
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 6 (n=31, 24)
|
-6.74 number of swollen joints
Standard Deviation 7.02
|
-5.21 number of swollen joints
Standard Deviation 6.35
|
|
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 6 (n=26, 20)
|
-8.31 number of swollen joints
Standard Deviation 6.80
|
-5.00 number of swollen joints
Standard Deviation 6.06
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Outcome measures
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Baseline (n=34, 31)
|
67.00 millimeter/hour (mm/hr)
Standard Deviation 27.50
|
60.77 millimeter/hour (mm/hr)
Standard Deviation 30.76
|
|
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 6 (n=34, 31)
|
-19.35 millimeter/hour (mm/hr)
Standard Deviation 27.03
|
-15.55 millimeter/hour (mm/hr)
Standard Deviation 33.19
|
|
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 12 (n=31, 25)
|
-20.36 millimeter/hour (mm/hr)
Standard Deviation 29.84
|
-21.64 millimeter/hour (mm/hr)
Standard Deviation 28.16
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Outcome measures
| Measure |
Rituximab
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Baseline (n=31, 24)
|
67.55 mm/hr
Standard Deviation 28.76
|
61.58 mm/hr
Standard Deviation 29.47
|
|
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 6 (n=31, 24)
|
-19.13 mm/hr
Standard Deviation 26.96
|
-23.21 mm/hr
Standard Deviation 31.33
|
|
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 12 (n=28, 20)
|
-21.54 mm/hr
Standard Deviation 30.51
|
-22.10 mm/hr
Standard Deviation 26.11
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Outcome measures
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Baseline (n=34, 31)
|
3.53 milligram/deciliter (mg/dL)
Standard Deviation 3.07
|
2.56 milligram/deciliter (mg/dL)
Standard Deviation 2.73
|
|
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 6 (n=34, 30)
|
-1.84 milligram/deciliter (mg/dL)
Standard Deviation 3.43
|
-0.74 milligram/deciliter (mg/dL)
Standard Deviation 3.25
|
|
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Change at Month 12 (n=31, 25)
|
-0.69 milligram/deciliter (mg/dL)
Standard Deviation 6.56
|
-1.51 milligram/deciliter (mg/dL)
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: Baseline, Month 6 and 12Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Outcome measures
| Measure |
Rituximab
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Baseline (n=31, 24)
|
3.53 mg/dL
Standard Deviation 3.17
|
2.59 mg/dL
Standard Deviation 2.78
|
|
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 6 (n=31, 24)
|
-1.79 mg/dL
Standard Deviation 3.56
|
-1.63 mg/dL
Standard Deviation 2.37
|
|
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Change at Month 12 (n=28, 20)
|
-0.60 mg/dL
Standard Deviation 6.88
|
-1.59 mg/dL
Standard Deviation 2.73
|
SECONDARY outcome
Timeframe: Month 6Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Outcome measures
| Measure |
Rituximab
n=33 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=30 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
|
0.69 units on a scale
Standard Deviation 0.70
|
0.40 units on a scale
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Month 6Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Outcome measures
| Measure |
Rituximab
n=30 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=24 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
|
0.73 units on a scale
Standard Deviation 0.71
|
0.46 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Baseline up to Month 12Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Outcome measures
| Measure |
Rituximab
n=34 Participants
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 Participants
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Adverse events
|
8 participants
|
8 participants
|
|
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Adverse drug reactions (ADR)
|
4 participants
|
5 participants
|
|
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Serious adverse events (SAE)
|
3 participants
|
0 participants
|
Adverse Events
Rituximab
Other Anti-TNF Agent
Serious adverse events
| Measure |
Rituximab
n=34 participants at risk
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 participants at risk
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Immune system disorders
Anaphylactoid reaction
|
2.9%
1/34 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
0.00%
0/31 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
0.00%
0/31 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.9%
1/34 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
0.00%
0/31 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
Other adverse events
| Measure |
Rituximab
n=34 participants at risk
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
|
Other Anti-TNF Agent
n=31 participants at risk
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/34 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
6.5%
2/31 • Baseline up to Month 12
The ITT set included participants who offered end-point results among the participants who received the study drugs after enrollment and met all inclusion/exclusion criteria.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER