Phase IIB Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects Who Are Not Responding to Methotrexate
Phase 2
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080221588
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 406
Inclusion Criteria
Inadequate response to Methotrexate.
Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of 7.5 mg and stable dose for 4 weeks prior to randomization.
ACR global function status class 1-3.
Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist.
High sensitivity C-reactive protein (hsCRP) more than 0.8 mg/d
Exclusion Criteria
Previously received or currently receiving concomitant biologic therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the efficacy of Clazakizumab subcutaneous (SC) vs placebo on a background of Methotrexate (MTX) as assessed by 20% American College of Rheumatology criteria (ACR) response.
- Secondary Outcome Measures
Name Time Method To assess additional efficacy outcomes of Clazakizumab SC at 12 weeks as measured by ACR50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes.<br><br><br>To assess efficacy of Clazakizumab SC at 24 weeks as measured by ACR 20, 50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. <br><br>To assess radiographic progression of joint damage by MRI at 12 Weeks.<br><br>To assess radiographic progression of joint damage by x-ray at 24 Weeks.<br><br>To assess safety and tolerability including immunogenicity rates.