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

RecruitingN/A

Sponsor: University Hospital, Tours

Conditions: Rheumatoid Arthritis (RA)

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

. 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 Criteria:

* 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.).

Locations (1)

Tours, France