Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rituximab.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Tapering of Rituximab Based on Interval Prolongation Compared to Disease Activity-guided Dose Reduction in Patients With Rheumatoid Arthritis: The RITUXERA Trial
Overview
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)
Interventions
- Drug Rituximab
IV rituximab
Primary outcome measures
- Comparison of disease impact in both study arms, measured using the Rheumatoid Arthritis Impact of Disease (RAID) questionnaire [Time frame: Over 2 years (104 weeks)]
Secondary outcome measures (11)
- Comparison of disease activity in both study arms, measured using the Disease Activity Score in 28 joints - C-reactive protein (DAS28-CRP) [Time frame: Over 2 years (104 weeks)]
- Comparison of disease activity in both study arms, measured using the Simplified Disease Activity Index (SDAI) [Time frame: Over 2 years (104 weeks)]
- Comparison of cumulative dose of rituximab in both study arms [Time frame: Over 2 years (104 weeks)]
- Comparison of cumulative dose of glucocorticoids in both study arms [Time frame: Over 2 years (104 weeks)]
- Proportion of patients in both study arms achieving a good or moderate European League Against Rheumatism (EULAR) treatment response after administration of rituximab, over a period of 2 years (104 weeks) [Time frame: Over 2 years (104 weeks)]
- Comparison of loss of disease control in both study arms [Time frame: Over 2 years (104 weeks)]
- Comparison of rituximab drug retention rate in both study arms [Time frame: Over 2 years (104 weeks)]
- Proportion of patients tapering rituximab below 1000 mg in the experimental arm [Time frame: Over 2 years (104 weeks)]
- Mean/median interval between rituximab administrations in the active comparator group [Time frame: Over 2 years (104 weeks)]
- Comparison of serious adverse events/reactions rates in both study arms. [Time frame: Over 2 years (104 weeks)]
- Comparison of serious infections rate in both study arms. [Time frame: Over 2 years (104 weeks)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 7 centers
- ZNA Jan Palfijn — Merksem
- Cliniques Universitaires Saint-Luc Bruxelles — Brussels
- Reumacentrum Genk — Genk
- ReumaClinic Genk — Genk
- OLV Aalst — Aalst
- RZ Heilig Hart — Leuven
- University Hospitals Leuven (UZ Leuven) — Leuven
Publications
- De Meyst E, Bertrand D, Joly J, Doumen M, Marchal A, Thelissen M, Neerinckx B, Westhovens R, Verschueren P. Treat-to-target fixed dose rituximab retreatment versus fixed interval retreatment with disease activity-guided rituximab dose optimisation for patients with rheumatoid arthritis: study protocol for a multicentre randomised controlled superiority trial focusing on long-term disease impact (R PMID 39407334
Identifiers
NCT: NCT06003283 · S67309