NCT06003283RecruitingPhase 4
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 19 Jul 2023
- Start date
- 9 Jan 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT06003283
- EU CT number
- 2023-506638-59-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 134
- From 9 Jan 2024 to the primary completion date, 31 Dec 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with another biological DMARD than rituximab.
- Current treatment with a targeted synthetic DMARD.
- Presence of an absolute contraindication to treatment with rituximab, according to the label of rituximab and according to medical judgement.
Other
- Pregnancy or pregnancy wish.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZORG Coordinator of this site? Confirm its status | Aalst | Belgium | Recruiting |
| Ziekenhuis Aan De Stroom Coordinator of this site? Confirm its status | Antwerp | Belgium | Recruiting |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Reumacentrum Genk Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| ReumaClinic Coordinator of this site? Confirm its status | Genk | Belgium | Recruiting |
| AZ St.-Elisabeth Herentals vzw Coordinator of this site? Confirm its status | Herentals | Belgium | Recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Recruiting |
| Regionaal Ziekenhuis Heilig Hart Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc Coordinator of this site? Confirm its status | Sint-Lambrechts-Woluwe | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.