A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects with Active Rheumatoid Arthritis Despite Diseasemodifying Antirheumatic Drug Therapy
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000564
- Lead Sponsor
- Janssen Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
The subject population comprises men and women aged 18 to 80 years, inclusive. Subjects must have had
RA for at least 6 months, and have active disease despite MTX, SSZ, and/or HCQ therapy. Active disease
is defined as at least 6 tender joints out of 68 and 6 swollen joints out of 66 at screening and baseline and
a serum CRP = 0.80 mg/dL at screening. Subjects must have been on MTX, SSZ, and/or HCQ therapy for
at least 6 months prior to screening, with a stable dose for a minimum of 8 weeks prior to screening.
Subjects are permitted to be receiving oral corticosteroids (prednisone = 10 mg/d, or equivalent
corticosteroid) provided their dose has been stable for at least 2 weeks prior to the first study agent
administration. Subjects are also permitted to be receiving nonsteroidal anti-inflammatory drugs or other
analgesics provided their dose has been stable for at least 2 weeks prior to the first study agent
administration.
Subjects will be excluded from the study if they have been treated with any biologic
antirheumatic agent in the past.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in DAS 28 (using CRP) at week12
- Secondary Outcome Measures
Name Time Method ACR20 responses rates at week12