Methotrexate and Metformin in Rheumatoid Arthritis Patients

Prior treatment

• 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

Other illness

• Patient with type 1 or type 2 diabetes
• History of allergy or intolerance to biguanide
• Decompensated heart failure
• Uncontrolled heart history
• Severe respiratory insufficiency
• Acute or chronic infection, such as tuberculosis or HIV
• Recent stroke
• Patient with stomatitis, mouth ulcers, or active gastrointestinal ulcer.

Lab values

• Presence of anemia (hemoglobin \< 80 g/l), neutropenia (neutrophils count \< 1500 mm3), lymphopenia (lymphocytes count \< 750 mm3), thrombopenia (platelets \< 100 000/mm3) or bone marrow hypoplasia.
• Renal insufficiency with clearance \< 50 ml/mn
• Hepatic insufficiency, or bilirubin level upper than 5mg/dl (85,5 µmol/l), or aspartate transaminase (ASAT) / alanine aminotransferase (ALAT) more than twice the standard level.

Age

• 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).

Other

• Critical ischemia of the lower limbs
• Patient with pleural effusion, or ascites
• Patient with alcohol intoxication
• B12 Vitamin deficiency
• Patient performing or planning to perform a long-fasting period
• Pregnant or breastfeeding women

• Patients aged over 18 years old,
• Patient affected by RA according to American College of Rheumatology (ACR) 2010 criteria
• DAS28-ESR \> 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 β-human chorionic gonadotropin (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)