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

Phase 1

• Conditions: rheumatoid arthritis; MedDRA version: 20.0Level: LLTClassification code 10042952Term: Systemic rheumatoid arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-004348-39-FR
• Lead Sponsor: CHU Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-16
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

RA patients in remission (DAS 28<2.6) with MTX treatment for at least 6months, and with a stable dose for 3months.
And patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28>3.2) with MTX treatment (= 15 mg/semaine), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (= 15 mg/semaine) treatment during the previous 3 months.
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 10

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