A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy.
Phase 3
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCT2080220469
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- adult patients, >=20 years of age;
- rheumatoid arthritis for >=3 months;
- inadequate response to previous or current treatment with at least one anti-TNF-alpha agent;
- receiving either leflunomide or methotrexate for >=12 weeks, with a stable dose for the last 4 weeks.
Exclusion criteria:
- rheumatic autoimmune disease or inflammatory joint disease, other than RA;
- any surgical procedure in past 12 weeks, or planned within 48 weeks of baseline.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method