Assessment of Rituximab's Immunomodulatory Synovial Effects (The ARISE Study)
- Registration Number
- NCT00147966
- Lead Sponsor
- University of California, San Diego
- Brief Summary
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.
- Detailed Description
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Active rheumatoid arthritis
- Use of concomitant methotrexate
- Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
- Serious medical conditions that would preclude the use of the treating agent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ritxumab rituximab all patients get treatment
- Primary Outcome Measures
Name Time Method American College of Rheumatology (ACR) 20 at Week 12 0 and 12 weeks ACR 20, the American College of Rheumatology (ACR) definition of 20% improvement is based on a 20% improvement (compared to baseline values) in tender and swollen joint counts and 20% improvement in 3 of the remaining 5 core set measures (subject global assessment of pain, subject global assessment of disease activity, physician global assessment of disease activity, subject assessment of physical function) and one acute phase reactant value (CRP).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UCSD CIT
🇺🇸La Jolla, California, United States