Assessment of the Immunomodulatory Effects of Rituximab in Seropositive Rheumatoid Arthritis Using Arthroscopic Synovial Biopsies
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- American College of Rheumatology (ACR) 20 at Week 12
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Active rheumatoid arthritis
- •Use of concomitant methotrexate
Exclusion Criteria
- •Use of disease-modifying anti-rheumatic drugs (DMARDs)/biologics other than methotrexate
- •Serious medical conditions that would preclude the use of the treating agent
Arms & Interventions
ritxumab
all patients get treatment
Intervention: rituximab (Drug)
Outcomes
Primary Outcomes
American College of Rheumatology (ACR) 20 at Week 12
Time Frame: 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 Outcomes
No secondary outcomes reported