Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided D
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
| Condition(s) | Rheumatoid Arthritis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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) |
| Who can participate | Inclusion Criteria: * Able and willing to give written informed consent and participate in the study before any study procedure. * Age ≥ 18 years. * Understanding and able to write in Dutch or French. * Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for rheumatoid arthritis. * Previous response to rituximab, defined as a minimum of one successful rituximab cycle (= a moderate/good EULAR response 16 weeks after the first administration of rituximab). * Current treatment with rituximab. * Need for a subsequent rituximab cycle according to the Belgian reimbursement criteria for the use of rituximab in rheumatoid arthritis (DAS28 score ≥3.2). * Stable dose of methotrexate or other c |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Merksem, Antwerpen, Belgium; Brussels, Brussels Capital, Belgium; Genk, Limburg, Belgium; Genk, Limburg, Belgium; Aalst, Oost-Vlaanderen, Belgium; Leuven, Vlaams-Brabant, Belgium (+1 more sites) |
| Start date | 2024-01-09 |
| NCT ID | NCT06003283 |
| Official listing | https://clinicaltrials.gov/study/NCT06003283 |