Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
Recruiting · NCT06003283 · Interventional (participants receive a specific treatment) · Lead sponsor: Universitaire Ziekenhuizen KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.
Exclusion criteria
- Current treatment with another biological DMARD than rituximab.
- Current treatment with 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.
Where it is running
7 locations listed.
- ZNA Jan Palfijn - Merksem, Antwerpen, Belgium
- Cliniques Universitaires Saint-Luc Bruxelles - Brussels, Brussels Capital, Belgium
- Reumacentrum Genk - Genk, Limburg, Belgium
- ReumaClinic Genk - Genk, Limburg, Belgium
- OLV Aalst - Aalst, Oost-Vlaanderen, Belgium
- RZ Heilig Hart - Leuven, Vlaams-Brabant, Belgium
- University Hospitals Leuven (UZ Leuven) - Leuven, Vlaams-Brabant, Belgium