eligibility_summary
Eligible: Adults (≥18) with RA per 2010 ACR/EULAR, Dutch/French literate, able to consent, prior successful rituximab response (≥1 cycle), currently on rituximab and needing next cycle per Belgian criteria (DAS28 ≥3.2), on stable methotrexate or other csDMARD ≥4 weeks. Exclude: use of other biologic or targeted synthetic DMARDs, pregnancy/pregnancy wish, or any contraindication to rituximab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06003283 (RITUXERA) compares two rituximab tapering strategies in rheumatoid arthritis: (1) disease activity–guided dose reduction every 24 weeks (step-down 1000→500→200 mg IV when DAS28-CRP ≤3.2, revert to prior effective dose if >3.2) versus (2) interval prolongation with fixed 1000 mg IV only when DAS28-CRP ≥3.2 and ≥24 weeks since the last infusion. Rituximab is a chimeric anti-CD20 monoclonal antibody (biologic DMARD) that depletes B cells via complement-dependent cytotoxicity, Fc-mediated ADCC, and apoptosis. Targets: CD20+ pre-/mature B cells (not plasma cells), reducing RF/ACPA autoantibodies, B–T cell costimulation/antigen presentation, and proinflammatory cytokine signaling (e.g., IL-6) in RA synovium.