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.
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.
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).
Adult patients with a diagnosis of rheumatoid arthritis meeting ACR/EULAR 2010 criteria on standard-dose rituximab with a good clinical response.
Case-only
Prospective
Not listed
Observed Disease Activity Score(DAS) 28-CRP
DAS28-CRP measured by the clinician 6 months after the second cycle of rituximab
Calculated DAS28-CRP
DAS28-CRP calculated 6 months after the second cycle of rituximab by a PK-PD model, taking into account gender, body surface area in m2, IgG concentration, rituximab concentration and CD4+ T-cell count
Prevalence observed DAS28-CRP
* Percentage of patients with a DAS28-CRP \< 3.2 at 3 months and 6 months of the first and second cycle of low-dose rituximab * Percentage of patients with a DAS28-CRP \<2.6 at 3 months and 6 months of the first and second cycle of low-dose rituximab
Description of events
Description of moderate and severe infectious events. Description of adverse events occurring during infusions
prevalence calculated DAS28-CRP
* percentage of patients with a predicted DAS 28 CRP \< 3.2 at 6 months of the second cycle of low-dose rituximab * percentage of patients with a predicted DAS 28 CRP \< 2.6 at 6 months of the second cycle of low-dose rituximab
CD4 T cell count
T cell count (\< 500/mm3)
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