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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Page 1 of 1 (1 locations)

1

Chu Saint Etienne

Saint-Etienne, France, 42055