Status:
RECRUITING
Evaluation of 200 mg of Rituximab Every 6 Months as Maintenance Treatment of Rituximab-treated Patients With Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Rheumatoid Arthritis (RA)
Rituximab (RTx)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease affecting joints and causing progressive disability. Current treatment strategies involve conventional disease-modifying anti-rheumatic drug...
Detailed Description
Rheumatoid arthritis (RA) is the most prevalent chronic inflammatory rheumatic disease in Europe, affecting 0.3%-0.5% of the population. Treatment follows a Treat-to-Target (T2T) approach, where patie...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06906549
Start Date
July 11 2025
End Date
July 1 2026
Last Update
July 23 2025
Active Locations (1)
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1
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098