Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

Phase 1

• Conditions: rheumatoid arthritis; MedDRA version: 21.0Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-003700-12-FR
• Lead Sponsor: CHU Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-04
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

RA patients with MTX treatment for at least 6months, and with a stable dose for 3 months (= 15 mg/semaine) and with first bDMARD treatment for at least 6 months

RA Patient in remission (DAS 28<2.6) .
or RA patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28>3.2)

Patients followed in the Rheumatology Department at the CHU de St Etienne.
Social security affiliation.
Signed informed consent.
Age >= 18 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Patients treated with another csDMARD.
Another diagnostic than RA

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Correlation between PG-MTX concentrations and clinical response to methotrexate + first biological drug in rheumatoid arthritis patients;Secondary Objective: Demonstrate that PG-MTX metabolits concentration are lower in non responder patients than in responder patients<br>Find association between PG-MTX metabolits concentration and Biodrugs concentration<br>Correlation between PG-MTX metabolits concentration and CQR score<br>;Primary end point(s): PG-MTX concentrations;Timepoint(s) of evaluation of this end point: Day 1

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PG-MTX metabolits concentration<br>Biodrugs concentration<br>CQR score;Timepoint(s) of evaluation of this end point: day 1