NCT06933134
Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis
Recruiting · Not specified · University Hospital, Tours · registry updated 2026-04-30
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Evaluation of the prediction of clinical response to rituximab at a dose of 1000 mg once using a pharmacological model including several pharmacokinetic and pharmacodynamic parameters.
Inclusion
- Age ≥ 18 years
- Diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria.
- Candidates for a Low Dose regimen: on standard dose rituximab and with a good clinical response according to the referring rheumatologist. No maximum duration of use of standard-dose rituximab has been defined.
- In the case of co-prescription of csDMARDs (Methotrexate, Leflunomide, Salazopyrine, Plaquenil), the dose must have been stable for 3 months.
- If corticosteroids are co-prescribed, the dose should be ≤ 10 mg/d and stable for 3 months.
Exclusion
- Other associated targeted disease-modifying therapy
- Sjögren's syndrome or other associated inflammatory rheumatism
- Fibromyalgia or other pathology having an impact on the assessment of disease activity
- Any active haematological disease affecting lymphocytes (chronic lymphocytic leukaemia, Hodgkin's and non-Hodgkin's lymphomas, lymphoplasmacytic lymphoma, T lymphoma).
- Opposition to data processing
- No inclusion of persons covered by articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (e.g. minors, protected adults, etc.).