Comparing two ways to taper rituximab in rheumatoid arthritis
Compares two rituximab tapering strategies in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
Key facts
- Where
- Aalst, Antwerp, Bonheiden, Edegem, Genk, Herentals, Jette, Leuven, Roeselare, and Sint-Lambrechts-Woluwe, BelgiumSee the 12 sites
- Phase
- Phase 4
Where in Belgium
- AZORGAalst, BelgiumTaking people
- Ziekenhuis Aan De StroomAntwerp, BelgiumTaking people
- ImeldaBonheiden, BelgiumTaking people
- Universitair Ziekenhuis AntwerpenEdegem, BelgiumTaking people
- Reumacentrum GenkGenk, BelgiumTaking people
- ReumaClinicGenk, BelgiumTaking people
- AZ St.-Elisabeth Herentals vzwHerentals, BelgiumTaking people
- UZ BrusselJette, BelgiumTaking people
- Regionaal Ziekenhuis Heilig Hart LeuvenLeuven, BelgiumTaking people
- UZ LeuvenLeuven, BelgiumTaking people
- Algemeen Ziekenhuis DeltaRoeselare, BelgiumTaking people
- Cliniques Universitaires Saint-LucSint-Lambrechts-Woluwe, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Trial code
- NCT06003283EU 2023-506638-59-01
- Record updated
- 31 May 2025
- Original description
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.Read full original descriptionShow less
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial
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)
Inclusion: 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: 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; Pregnancy or pregnancy wish.