Phase 2b, Rheumatoid Arthritis Dose Ranging Study for Clazakizumab in Subjects who have Experienced an Inadequate Response to TNF inhibitors.
Phase 2
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080222447
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Inadequate responders to TNF inhibitors.
-All subjects must have been receiving treatment with a minimum dose of 7.5 mg per week of methotrexate for at least 12 weeks and at a stable dose for 4 weeks prior to screening.
-ACR global functional status class of 1 to 3.
-Minimum of 6 swollen and 6 tender joints on a 66/68 joint count.
-High sensitivity C-reactive protein (hsCRP) 0.8 mg/dL and above.
Exclusion Criteria
Subjects who have ever received tocilizumab or any investigational IL-6 inhibitor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of clazakizumab versus placebo on a background of methotrexate as assessed by change from baseline in DAS28-CRP at 12 weeks.
- Secondary Outcome Measures
Name Time Method Assess the efficacy of clazakizumab on a background of methotrexate in reducing signs and symptoms of rheumatoid arthritis by measures such as ACR rates, remission rates, and DAS28-CRP less than 2.6, over 12 weeks of treatment.<br>Assess the efficacy of clazakizumab on a background of methotrexate in improving physical function as determined by change from baseline in HAQ-DI at 12 weeks of treatment.<br>Assess the safety of clazakizumab on a background of methotrexate by assessment of Adverse Events (AEs) and laboratory parameters.<br>Characterize the pharmacokinetics, immunogenicity, pharmacodynamics and biomarker responses of different clazakizumab doses on a background of methotrexate.