Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

Phase 4

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03445871
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Study Start: 2018-07-02
• Status Verified: 2020-01
• Primary Completion: 2020-05-28
• Study Completion: 2020-05-28
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age > 18 years and have social security affiliation.

• Patients followed in the Rheumatology Department at the hospital of St Etienne.

• Patients with rheumatoid arthritis and :

  • Either Rheumatoid arthritis patients in remission (DAS 28<2.6) with MTX treatment for at least 6months, and with a stable dose for 3months.
  • Or patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28>3.2) with MTX treatment (≥ 15 mg/weeks), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/weeks) 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
MTX-PG concentration	Hour 1	To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission

Secondary Outcome Measures

Name	Time	Method
different metabolites dosing of MTX-PG	Hour 1	Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
CQR score	Hour 1	Analysis of CQR score response

Trial Locations

Locations (1)

Chu Saint Etienne; 🇫🇷 Saint-etienne, France