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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

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

30 Participants
are grouped into 1 trial group

Locations

1
University hospital37044, Tours France

Sponsors and collaborators

University Hospital, Tours

Lead sponsor