200 mg rituximab every six months for maintenance in rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.