EICHORCondition: Rheumatoid Arthritis · Sponsor: Universitaire Ziekenhuizen KU Leuven
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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)
This description comes directly from the study's public registry record.
Patrick Verschueren, MD, PhD · 016342541 · patrick.verschueren@uzleuven.be
Johan Joly, MSc · 016340258 · johan.joly@uzleuven.be
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| ZNA Jan Palfijn | Merksem, Antwerpen, Belgium | Not Yet Recruiting |
| Cliniques Universitaires Saint-Luc Bruxelles | Brussels, Brussels Capital, Belgium | Not Yet Recruiting |
| Reumacentrum Genk | Genk, Limburg, Belgium | Recruiting |
| ReumaClinic Genk | Genk, Limburg, Belgium | Recruiting |
| OLV Aalst | Aalst, Oost-Vlaanderen, Belgium | Recruiting |
| RZ Heilig Hart | Leuven, Vlaams-Brabant, Belgium | Recruiting |
| University Hospitals Leuven (UZ Leuven) | Leuven, Vlaams-Brabant, Belgium | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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Source record: clinicaltrials.gov/study/NCT06003283