Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug (POLYbio)

  • STATUS
    Recruiting
  • End date
    Jan 21, 2024
  • participants needed
    60
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 21 March 2022
remission
methotrexate
DMARD
antirheumatics

Summary

The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.

Details
Condition Rheumatoid Arthritis
Treatment Blood sample, CRQ
Clinical Study IdentifierNCT04470453
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age > 18 years and have social security affiliation
Patients followed in the Rheumatology Department at the hospital of St Etienne
Rheumatoid Arthritis patients in remission (Disease Activity Score 28<2.6) with methotrexate (MTX) treatment for at least 6months, and with a stable dose for 3months
Patients with a High Disease Activity Rheumatoid Arthritis activity (Disease Activity Score 28>3.2) with methotrexate (MTX) treatment (≥ 15 mg/week), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/week) treatment during the previous 3 months
Signed informed consent

Exclusion Criteria

Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
Another diagnostic than rheumatoid arthritis
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