Methotrexate and Metformin in rheumatoid arthritis patients

Phase 1

• Conditions: rheumatoid arthritis (RA); MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2018-004287-56-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-31
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

- Patients aged over 18 years old,
- Patient affected by RA according to ACR 2010 criteria
- DAS28 > 3.2
- Methotrexate naïve patients, or without any methotrexate intake for more than six months.
- Men who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment. Partner of patient will be informed of teratogenicity of MTX and will be advised to be on effective contraceptives for all the study duration.
OR
- Women with a negative test of ß-HCG who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment
- Patients without any Metformin previous therapy.
- Being affiliated to a health insurance system
- Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)

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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Patient who present contraindications to treatment with Methotrexate or Metformin
- Patient with daily corticosteroid treatment at a dosage = 15 mg/day within four weeks before the inclusion
- History of allergy or intolerance to biguanide
- Renal insufficiency with clearance < 60 ml/mn
- Decompensated heart failure
- Coronary insufficiency
- Severe respiratory insufficiency
- Hepatic insufficiency
- Acute infection
- Critical ischemia of the lower limbs
- Recent stroke
- B12 Vitamin deficiency
- Patient performing or planning to perform a long-fasting period
- Pregnant or breastfeeding women
- Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

Study & Design

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