Methotrexate and Metformin in rheumatoid arthritis patients.

Phase 1

Conditions: rheumatoid arthritis (RA)
MedDRA version: 20.0Level: HLTClassification code: 10039075Term: Rheumatoid arthritis and associated conditions Class: 10021428
Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

Registration Number: CTIS2024-511033-35-00

Lead Sponsor: Centre Hospitalier Universitaire De Bordeaux

Brief Summary: Not available

Detailed Description: Not available

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-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., 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., 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., 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)., 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., Severe respiratory insufficiency., Hepatic insufficiency, or bilirubin level upper than 5mg/dl (85,5µmol/l), or ASAT/ALAT more than twice the standard level.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of Methotrexate/Metformin vs. Methotrexate alone on the decrease of RA activity in MTX-naive patients, after 6 months of treatment.;Secondary Objective: Describe the proportion of patients achieving remission (DAS28-ESR = 6.6) at 6, 12 and 24 months in both randomization groups., Describe the proportion of patients achieving a low level of activity (DAS28-ESR = 3.2) at 6 months in both randomization groups., Describe the mean dose of Methotrexate prescribed at 6, 12 and 24 months in both randomization groups., Describe the mean dose of Methotrexate prescribed at 6, 12 and 24 months in both randomization groups., Describe clinical and laboratory parameters related to metabolism in both randomization groups., Describe the frequency of occurrence of serious adverse events in both randomization groups., Describe the quality of life of patients in both randomization groups.;Primary end point(s): Level of RA activity according to Disease Activity score on 28 joints (DAS28).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6).;Secondary end point(s):Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2).;Secondary end point(s):Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment.;Secondary end point(s):Description of some metabolic parameters within the two groups of treatment: weight loss, waist circumference, fasting glycemia and hemoglobin A1c level (HbA1c), cholesterol levels, triglycerids, insulinemia, and bilirubin.;Secondary end point(s):Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment.;Secondary end point(s):Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment.

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