A Synovial Biopsy Study of JNJ-38518168 in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
The purpose of this study is to assess the impact of JNJ-38518168 on rheumatoid arthritis (RA) disease-related biomarkers in synovial biopsy tissue and blood in participants with active RA despite methotrexate (MTX) therapy and to assess the safety and tolerability of JNJ-38518168 over one year.
Drug: Placebo / JNJ-38518168
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Synovial Biopsy Study of JNJ-38518168 in Subjects With Active Rheumatoid Arthritis Despite Methotrexate Therapy|
- Assessment of rheumatoid arthritis (RA) biomarkers [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]Biomarkers may include, but are not limited to, inflammatory markers and cytokines; synovium/cartilage/bone markers; and gene expression profiles.
- Number of participants reporting adverse events as a measure of safety and tolerability [ Time Frame: Up to Week 56 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
JNJ-38518168 30 mg once daily, Week 0 to Week 52.
|Placebo Comparator: Placebo / JNJ-38518168||
Matching placebo once daily (Week 0 to Week 12).Drug: Placebo / JNJ-38518168
JNJ-38518168 30 mg once daily, Week 12 to Week 52.
This is a randomized (participants assigned to treatment by chance), double-blind (participants and study personnel will not know what treatment is being given), placebo-controlled (a placebo appears identical to a study drug, but contains no active ingredients), parallel-group (treatments will be given to groups of participants at the same time) study. Participants will be randomly assigned in a 3:1 ratio to receive either JNJ-38518168 for 52 weeks or receive matching placebo for 12 weeks, followed by JNJ-38518168 for 40 weeks. The total duration of participation will be approximately 60 weeks for all participants, including a screening visit and follow-up visits. Safety and tolerability of JNJ-38518168 will be evaluated by monitoring adverse events reported by participants throughout the study . In addition, results from clinical laboratory tests, electrocardiograms, vital signs measurements, and physical examinations performed during the study will be monitored.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862224
|United States, Maryland|
|Frederick, Maryland, United States|
|United States, Texas|
|Mesquite, Texas, United States|
|Moldova, Republic of|
|Chisinau, Moldova, Republic of|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|