About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
1Sponsors and collaborators
University Hospital, Tours
Lead sponsor