200 mg rituximab every six months for maintenance in rheumatoid arthritis
Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis: a Non-inferiority Prospective Randomised Controlled Trial
This will test whether giving 200 mg of rituximab every six months keeps rheumatoid arthritis under control in people already on rituximab who have low disease activity.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | Rituximab, methotrexate |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06906549 on ClinicalTrials.gov |
What this trial studies
The RADAR trial is a multicenter, randomized, double-blind, non-inferiority phase 4 trial comparing 200 mg versus 1 g rituximab given every six months as maintenance in RA patients with low disease activity. Eligible adults on maintenance rituximab (last infusion 6–18 months prior) will be randomized and followed for 12 months with the primary outcome of DAS28-CRP at month 12. Secondary endpoints include treatment failure, infection and immunoglobulin safety measures, and patient-reported outcomes. The trial builds on prior data suggesting lower doses may maintain disease control while reducing immunosuppression and cost.
Who should consider this trial
Good fit: Adults with RA meeting EULAR/ACR criteria who are on rituximab, have DAS28 ≤5.1, and received their last rituximab infusion 6–18 months before enrollment are ideal candidates.
Not a fit: Patients with high or uncontrolled disease activity, concurrent targeted therapies other than rituximab, contraindications to rituximab, or significant uncontrolled comorbidities are unlikely to benefit from switching to a lower maintenance dose.
Why it matters
Potential benefit: If successful, patients could maintain disease control with a much lower rituximab dose, potentially lowering infection risk and reducing treatment costs.
How similar studies have performed: A prior randomized trial showed 500 mg was non-inferior to 1 g, and smaller or underpowered data plus longer-term follow-up suggest 200 mg may be effective but definitive evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Strasbourg
- Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.