Trial Outcomes & Findings for Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis (NCT NCT02699892)
NCT ID: NCT02699892
Last Updated: 2016-10-26
Results Overview
DAS28 score is a measure of participant's disease activity calculated using tender joint count \[28 joints\] (TJC28), swollen joint count \[28 joints\] (SJC28), participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \[0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of greater than (\>) 3.2 to \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.
COMPLETED
130 participants
Baseline, 24 weeks after first rituximab infusion (Week 24)
2016-10-26
Participant Flow
There was no documentation for the reason for discontinuation; hence, in Participant Flow module, for all participants who did not complete the study, the reason is reported as Unspecified.
Participant milestones
| Measure |
Rheumatoid Arthritis Participants
Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
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|---|---|
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Overall Study
STARTED
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130
|
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Overall Study
COMPLETED
|
94
|
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Overall Study
NOT COMPLETED
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36
|
Reasons for withdrawal
| Measure |
Rheumatoid Arthritis Participants
Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
|
|---|---|
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Overall Study
Other
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36
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Baseline Characteristics
Study to Examine Efficacy and Safety of Rituximab in Participants With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Rheumatoid Arthritis Participants
n=130 Participants
Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
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|---|---|
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Age, Continuous
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51.28 Years
STANDARD_DEVIATION 11.75 • n=93 Participants
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Sex: Female, Male
Female
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110 Participants
n=93 Participants
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Sex: Female, Male
Male
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20 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline, 24 weeks after first rituximab infusion (Week 24)Population: ITT population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome.
DAS28 score is a measure of participant's disease activity calculated using tender joint count \[28 joints\] (TJC28), swollen joint count \[28 joints\] (SJC28), participant's global assessment of disease activity (PGH) \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\] and erythrocyte sedimentation rate (ESR). DAS28 was calculated according to following formula: \[0.56 multiplied by (\*) square root (√) of TJC\] plus (+) \[0.28\*√SJC\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*PGH\]. Total possible score of 0 to approximately 10, where higher scores represented higher disease activity. Scores below 2.6 indicated clinical remission, score of less than or equals to (\</=) 3.2 indicated low disease activity, score of greater than (\>) 3.2 to \</=5.1 indicated moderate disease activity, scores above 5.1 indicated high or severe disease.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=112 Participants
Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
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|---|---|
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Percentage of Participants Achieving Reduction From Baseline in Disease Activity Score Based on 28 Joints Count (DAS28) of More Than 1.2 Units After 24 Weeks of First Rituximab Infusion
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61.60 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 24, 48 and 72Population: ITT Population. Here, "number of participants analyzed" signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.
Clinical response was assessed according to EULAR categorical DAS28 response criteria, which defined clinically meaningful improvement at Weeks 24, 48, and 72. EULAR response was based on change from baseline (CFB) in DAS28 score and on actual DAS28 score, at Weeks 24, 48, and 72. DAS28 score: participant's disease activity calculated using TJC28, SJC28, PGH \[VAS: 0=no disease activity to 100=maximum disease activity\] and ESR. DAS28 was calculated by following formula: (0.56\*√TJC)+(0.28\*√SJC)+(0.70\*ln ESR)+(0.014\*PGH). Total possible score = 0-10, higher scores represented higher disease activity. EULAR Good response: DAS28\</=3.2; reduction of DAS28 \>1.2.
Outcome measures
| Measure |
Rheumatoid Arthritis Participants
n=112 Participants
Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
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|---|---|
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Percentage of Participants With European League Against Rheumatism (EULAR) Good Response
Week 24 (n=112)
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21.43 Percentage of participants
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Percentage of Participants With European League Against Rheumatism (EULAR) Good Response
Week 48 (n=81)
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16.05 Percentage of participants
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Percentage of Participants With European League Against Rheumatism (EULAR) Good Response
Week 72 (n=59)
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18.64 Percentage of participants
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Adverse Events
Rheumatoid Arthritis Participants
Serious adverse events
| Measure |
Rheumatoid Arthritis Participants
n=130 participants at risk
Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
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|---|---|
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Immune system disorders
Drug hypersensitivity
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3.1%
4/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Immune system disorders
Urticaria
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Immune system disorders
Anaphylactic reaction
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Infections and infestations
Streptococcal sepsis
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Investigations
Transaminases increased
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Gastrointestinal disorders
Gastritis
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
|
|
Gastrointestinal disorders
Colitis
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
|
|
Renal and urinary disorders
Pyelonephritis acute
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
|
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Vascular disorders
Hypertension
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
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0.77%
1/130 • Baseline up to end of the study (up to 72 weeks )
Safety population included all participants who received at least one dose of drug under observation and had a subsequent safety assessment.
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Other adverse events
Adverse event data not reported
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