Status:
TERMINATED
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
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 MT...
Eligibility Criteria
Inclusion
- 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
- Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
- Another diagnostic than rheumatoid arthritis
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04470453
Start Date
October 8 2020
End Date
April 4 2024
Last Update
January 20 2025
Active Locations (1)
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1
Chu Saint Etienne
Saint-Etienne, France, 42055