A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597739
|Buenos Aires, Argentina|
|San Juan, Argentina|
|San Miguel De Tucuman, Argentina|
|Veliko Turnovo, Bulgaria|
|Praha 4, Czech Republic|
|Praha 5, Czech Republic|
|Slany, Czech Republic|
|Korea, Republic of|
|Gwangju, Korea, Republic of|
|Seoul, Korea, Republic of|
|Suwon, Korea, Republic of|
|Kazan, Russian Federation|
|Moscow, Russian Federation|
|Novosibirsk, Russian Federation|
|Petrozavodsk, Russian Federation|
|Saint Petersburg, Russian Federation|
|Ulyanovsk, Russian Federation|
|Yaroslavl, Russian Federation|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|