Optimizing Rituximab Tapering Strategies for Rheumatoid Arthritis
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial
This study is testing two different ways to reduce the dose of rituximab in people with rheumatoid arthritis to see which method helps them feel better and manage their condition more effectively.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | rituximab, methotrexate |
| Locations | 7 sites (Merksem, Antwerpen and 6 other locations) |
| Trial ID | NCT06003283 on ClinicalTrials.gov |
What this trial studies
This open-label multicenter randomized controlled trial aims to determine the best tapering strategy for rituximab in patients with rheumatoid arthritis. Participants will be randomly assigned to either a disease-activity guided dose reduction or an interval prolongation approach. The study focuses on assessing the impact of these strategies on patient-reported disease outcomes and therapeutic efficacy. By comparing these two methods, the trial seeks to identify the most effective way to manage treatment for rheumatoid arthritis patients currently on rituximab.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of rheumatoid arthritis who have previously responded to rituximab and require a subsequent cycle.
Not a fit: Patients currently receiving another biological DMARD or those who do not meet the criteria for rituximab treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with rheumatoid arthritis, potentially improving their quality of life.
How similar studies have performed: While there have been studies on rituximab for rheumatoid arthritis, this specific approach to tapering based on disease activity versus interval prolongation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Merksem, Antwerpen and 6 other locations
- 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)
Study contacts
- Principal investigator: Patrick Verschueren, MD, PhD — University Hospitals Leuven/KU Leuven
- Study coordinator: Patrick Verschueren, MD, PhD
- Email: patrick.verschueren@uzleuven.be
- Phone: 016342541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.