Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Aug 17, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the best way to reduce the dosage of rituximab, a medication used to treat rheumatoid arthritis, based on how active the disease is or by extending the time between doses. The goal is to find a method that helps patients feel better while still keeping the treatment effective. Participants will be randomly assigned to one of two groups: one group will reduce their medication based on how their disease is responding, while the other group will have their doses spaced out longer.

To be eligible for this study, participants need to be at least 18 years old, have a confirmed diagnosis of rheumatoid arthritis, and have previously responded well to rituximab treatment. They should also be currently using rituximab and need another treatment cycle. This trial is open to anyone who speaks Dutch or French and is willing to provide written consent. If you choose to participate, you'll be monitored closely to see how well the different tapering strategies work for you. It's an important opportunity to help improve treatment approaches for rheumatoid arthritis.

Gender

ALL

Eligibility 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.