rheumatoid arthritis (RA) MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870
Conditions
Interventions
Trade Name: METFORMINE ARROW 500mg
Product Name: Metformin
Pharmaceutical Form: Cachet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Trade Name: Methotr
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 =6.6) at 6, 12 and 24 months in both randomization groups. - Describe the proportion of patients achieving a low level of activity (DAS28 = 3.2) at 6 months in both randomization groups. - Describe the proportion of patients for whom biotherapy is considered 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);Timepoint(s) of evaluation of this end point: After 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6) - Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2) - Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment - Mean dosage of Methotrexate in the two groups of randomization - 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. - Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment - Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment;Timepoint(s) of evaluation of this end point: After 6 months of treatment | — |
Countries
France
Contacts
Public ContactLaetitia LACAZE-BUZY
CHU de BORDEAUX
Outcome results
None listed