Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis
Recruiting · NCT06906549 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Strasbourg, France
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Rheumatoid arthritis (RA) is a chronic inflammatory disease affecting joints and causing progressive disability. Current treatment strategies involve conventional disease-modifying anti-rheumatic drugs (csDMARDs) and, in more resistant cases, biologic DMARDs (bDMARDs) such as Rituximab. Rituximab, a monoclonal antibody targeting CD20-positive B cells, is administered as an induction dose followed by maintenance therapy every six months. Standard maintenance dosing consists of 1g infusions, but lower doses may provide equivalent efficacy with fewer side effects. The RADAR trial is a multicenter, prospective, randomized, double-blinded, non-inferiority controlled trial designed to evaluate whether a 200 mg maintenance dose of Rituximab every six months is non-inferior to the standard 1g dose in patients with RA who are in low disease activity. The study will assess disease activity using the DAS28-CRP score over 12 months, alongside various secondary endpoints, including treatment failure rates, immune responses, and adverse events. By determining the minimum effective Rituximab dose, the study aims to optimize patient safety, reduce the risk of infections, and lower healthcare costs. This trial is particularly relevant as Rituximab has lost patent protection, making cost-effective treatment crucial, especially in low-resource settings. Findings from this study could lead to updated treatment guidelines, benefiting RA patients worldwide.
Who can take part
Inclusion criteria
- Age ≥ 18 years
- Diagnosis of rheumatoid arthritis (RA) according to EULAR/ACR 2010 classification criteria
- DAS28 ≤ 5.1
- Current maintenance treatment with Rituximab regardless of dose and/or duration of Rituximab treatment and with at least first cycle of Rituximab ended (2 initial infusions)
- Last Rituximab infusion between 6 and 18 months prior to inclusion
- Corticosteroids ≤10 mg/day within 4 weeks prior to inclusion
- Affiliation to a social insurance system or beneficiary
- Written informed consent to participate in the study, dated and signed before starting the trial
- Effective method of birth control during the study
Exclusion criteria
- Rheumatic autoimmune disease other than RA (except associated Sjogren's disease, which is allowed)
- Concurrent treatment with any other targeted therapy than Rituximab
- Any contraindication to Rituximab or to NaCl 0.9%
- Significant uncontrolled associated disease or comorbidity
- Known active infection or history of serious recurrent or chronic infection
- Laboratory findings: active or untreated latent tuberculosis, hepatitis B positive, hepatitis C positive, haemoglobin \<8 g/dL, neutropenia \< 1.5G/L, IgM \<0.4 g/L and/or IgG \<5 g/L
- Pregnancy, breastfeeding, or planned pregnancy during the study (on subject declaration)
- Drug addiction, alcohol addiction
- Patients who cannot be followed for the 12 month-duration
- Patients over the age of legal majority who are protected, or deprived of liberty by judicial or administrative decision
- Subject in exclusion period (determined by a previous or ongoing study)
- Patients unable to give informed consent (e.g., patients in a situation of medical emergency, patients who have difficulty comprehending the essential details of the trial...)
- Patients who have difficulty reading or understanding French, or who have an inability to understand the delivered information
Where it is running
1 location listed.
- Hôpitaux Universitaires de Strasbourg - Strasbourg, France