A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
|ClinicalTrials.gov Identifier: NCT01597739|
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : April 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Drug: JNJ-40346527 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
|Placebo Comparator: Placebo||
Form=capsule; route=oral use; twice daily.
- Change from baseline in the Disease Activity Score (DAS28), using C-reactive protein (CRP) [ Time Frame: Week 12 ]The DAS28 is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and an overall assessment of disease activity.
- ACR 20 response [ Time Frame: Week 12 ]ACR 20 (American College of Rheumatology) response is a 20% improvement in rheumatoid arthritis (RA) symptoms.
- DAS28 (using CRP) response [ Time Frame: Week 12 ]DAS28 response is the improvement from baseline and is rated as "No response," Moderate response," or "Good response."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597739
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|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|