Clinical Trial

Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis

Study acronym: RITUXERA
Recruiting Phase 4
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Summary
The goal of this open label multicenter randomized controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis. The main questions it aims to answer are: * What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of reducing patient reported disease impact? * What is the optimal treatment/tapering strategy for rituximab in patients with rheumatoid arthritis in terms of therapeutic efficacy? Participants will be randomized to one of two study arms: * Tapering based on disease-activity guided dose reduction (experimental arm) * Tapering based on interval prolongation (active comparator arm)
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-08-17; most recent amendment 2025-05-26.
Status change: Not Yet Recruiting → Recruiting 2024-06-19
Trial Details
NCT Number NCT06003283
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: Fonds voor Wetenschappelijk Reumaonderzoek (FWRO)
Conditions Rheumatoid Arthritis
Enrollment 134 participants
Start Date 2024-01-09
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-05-31