Optimizing Rituximab Tapering Strategies for Rheumatoid Arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• ZNA Jan Palfijn
  Merksem, Antwerpen, Belgium Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.