Actively Recruiting
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-05-31
134
Participants Needed
7
Research Sites
203 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
F
Fonds voor Wetenschappelijk Reumaonderzoek (FWRO)
Collaborating Sponsor
AI-Summary
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)
CONDITIONS
Official Title
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent and participate in the study before any study procedure.
- Age �3A 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 �3A3.2).
- Stable dose of methotrexate or other conventional synthetic disease-modifying antirheumatic drugs (DMARDs) 4 weeks prior to baseline.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
ZNA Jan Palfijn
Merksem, Antwerpen, Belgium, 2170
Not Yet Recruiting
2
Cliniques Universitaires Saint-Luc Bruxelles
Brussels, Brussels Capital, Belgium, 1000
Not Yet Recruiting
3
Reumacentrum Genk
Genk, Limburg, Belgium, 3600
Actively Recruiting
4
ReumaClinic Genk
Genk, Limburg, Belgium, 3600
Actively Recruiting
5
OLV Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300
Actively Recruiting
6
RZ Heilig Hart
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
7
University Hospitals Leuven (UZ Leuven)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
P
Patrick Verschueren, MD, PhD
CONTACT
J
Johan Joly, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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