Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-Guided Dose Reduction in Patients with Rheumatoid Arthritis: The RITUXERA Trial.

Phase 1

Recruiting

• Conditions: Rheumatoid arthritis; MedDRA version: 21.0Level: PTClassification code: 10039073Term: Rheumatoid arthritis Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: CTIS2023-506638-59-01
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 134

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 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 a biological disease modifying antirheumatic drug (bDMARD) other than rituximab., Current treatment with a targeted synthetic DMARD., Pregnancy or pregnancy wish., Hypersensitivity to rituximab or to its excipients., Active severe infection., Severe immune deficiency., Severe heart failure (New York Heart Association (NYHA) Class IV) or other severe uncontrolled cardiac condition.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective of this open label multicenter randomised controlled pragmatic superiority trial is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis with a goal of reducing disease impact.;Secondary Objective: The main secondary objective is to investigate the optimal treatment/tapering strategy with rituximab for patients with rheumatoid arthritis to reduce disease activity.;Primary end point(s): Comparison between both study arms of disease impact (area under the curve (AUC) of the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire) over 104 weeks.