A Phase 4 interventional study of Blood sample and CRQ in Rheumatoid Arthritis, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-03.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 4, Interventional, and Treatment
Methotrexate (MTX) is the first-line treatment of rheumatoid arthritis (RA). In case of MTX failure, it is discussed to start a Biologic Disease-modifying Antirheumatic Drug (bDMARDs) according to the latest European recommendations of the EULAR. Before to add a Biologic Disease-modifying Antirheumatic Drug (bDMARDs), an objective estimation of MTX impregnation could be carried out by MTX polyglutamates (MTX-PG). In rheumatoid arthritis patients with active disease estimated by DAS28 (Disease activity Score 28)> 3.2 insufficiently controlled by MTX subcutaneously and patients in remission obtained with a DAS 28 \<2.6 with methotrexate prescribed since more than 6 months at stable dose for at least 3 months, a concentration of MTX-PG will be achieved.
The assumption is the association between low methotrexate erythrocyte polyglutamate and low clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate. Adherence to MTX will be assessed by the Compliance Questionnaire Rheumatology (CQR). Measurement of this adherence could optimize MTX treatment prior to the use of biotherapy which is costly with a lower infectious tolerance.
Correlation between its concentration and compliance assessed by CQR questionnaire will be tested.
Patients with rheumatoid arthritis and :
Exclusion Criteria:
Patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
Biological: Blood sample · Diagnostic Test: CRQ
Patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
Biological: Blood sample · Diagnostic Test: CRQ
Blood samples will be collected for measuring PG-MTX blood concentration.
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Also known as: Compliance Rheumatology Questionnaire
MTX-PG concentration
To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission
Time frame: Hour 1
different metabolites dosing of MTX-PG
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
Time frame: Hour 1
CQR score
Analysis of CQR score response
Time frame: Hour 1
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne