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Checking a Blood Test Method for Low-Dose Rituximab in Rheumatoid Arthritis

Studies whether a drug-level model predicts response to one rituximab dose in adults with arthritis.

Plain-language title generated from the registry record
Registry title: Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis

Key facts

Where
Tours, FranceSee the site

Where in France

  • University hospitalTours, FranceTaking people

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Trial details

Who runs it
University Hospital, Tours
Trial code
NCT06933134
Record updated
30 April 2026
Original description
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.Read full original descriptionShow less

Prospective Validation of a Pharmacological Biomarker for Low-Dose Rituximab in Rheumatoid Arthritis

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.).

ClinicalTrials.gov NCT06933134