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

Study acronym: RITUXERA
StatusRecruiting
PhasePhase 4
Started2024-01-09
View on ClinicalTrials.gov ↗

Amendment history

2025-05-26
Study Status, Contacts/Locations v3
Primary completion date2026-12-29→2027-12
Completion date2026-12-29→2027-12
Study sitesdetails revised at 1 of 7 sites
2024-06-19
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12-29→confirmed 2024-01-09
Study sitesdetails revised at 7 of 7 sites
2023-12-19
Study Status, Outcome Measures, Eligibility v1
Primary completion date2026-11-01→2026-12-29
Completion date2026-11-01→2026-12-29
Start date2023-11-01→2023-12-29
Eligibility criteria+142 characters
[...] ith a targeted synthetic DMARD. Pregnancy or pregnancy wish. Presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.
Secondary endpoints9 to 11 entries
Comparison of serious adverse events/reactions rates in both study arms. Comparison of serious infections rate in both study arms.
2023-08-17
Original filing
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)
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