Methotrexate and Metformin in Rheumatoid Arthritis Patients

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Dec 10, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two medications, Methotrexate and Metformin, on patients with rheumatoid arthritis (RA). Methotrexate is commonly used to treat RA, but about one-third of patients do not achieve complete relief from their symptoms. Metformin, typically used for diabetes, may help reduce inflammation, making it a potential option for improving RA treatment.

To participate in the trial, individuals must be at least 18 years old and diagnosed with RA according to specific criteria. They should not have taken Methotrexate in the past six months and should not have used Metformin previously. Participants will be required to use effective contraception during the study and for six months after treatment with Methotrexate. The trial is currently active but not recruiting new participants. If eligible, participants can expect to receive careful monitoring and support throughout the study to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • Patient who present contraindications to treatment with Methotrexate or Metformin
• • Patient with type 1 or type 2 diabetes
• • Patient with daily corticosteroid treatment at a dosage ≥ 15 mg/day within four weeks before the inclusion
• • History of allergy or intolerance to biguanide
• • 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
• • Decompensated heart failure
• • Uncontrolled heart history
• • Severe respiratory insufficiency
• • 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.
• • Acute or chronic infection, such as tuberculosis or HIV
• • Critical ischemia of the lower limbs
• • Recent stroke
• • Patient with pleural effusion, or ascites
• • Patient with stomatitis, mouth ulcers, or active gastrointestinal ulcer.
• • Patient with alcohol intoxication
• • 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).