METFORMIN HYDROCHLORIDE for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Patients aged over 18 years old.\n- Patient affected by RA according to ACR 2010 criteria.\n- DAS28-ESR > 3.2\n- Methotrexate naïve patients, or without any methotrexate intake for more than six months.\n- 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.\n- Women with a negative test of β-HCG who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment.\n- Being affiliated to a health insurance system.\n- Having signed an informed consent form (later than the day of inclusion and before any examination required by the research)."}

Exclusion criteria

• {"criterion_text":"- Patient who present contraindications to treatment with Methotrexate or Metformin.\n- Acute or chronic infection, such as tuberculosis or HIV.\n- Critical ischemia of the lower limbs.\n- Recent stroke.\n- Patient with pleural effusion, or ascites.\n- Patient with stomatitis, mouth ulcers, or active gastrointestinal ulcer.\n- Patient with alcohol intoxication.\n- B12 Vitamin deficiency.\n- Patient performing or planning to perform a long-fasting period.\n- Pregnant or breastfeeding women.\n- 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).\n- Patient with type 1 or type 2 diabetes.\n- Patient with daily corticosteroid treatment at a dosage ≥ 15 mg/day within four weeks before the inclusion.\n- History of allergy or intolerance to biguanide.\n- 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.\n- Renal insufficiency with clearance < 50 ml/mn.\n- Decompensated heart failure.\n- Severe respiratory insufficiency.\n- Hepatic insufficiency, or bilirubin level upper than 5mg/dl (85,5µmol/l), or ASAT/ALAT more than twice the standard level."}

Primary endpoints

• {"endpoint_text":"- Level of RA activity according to Disease Activity score on 28 joints (DAS28).","definition_or_measurement_approach":"Measured by the Disease Activity Score on 28 joints (DAS28), e.g. DAS28-ESR (DAS28-VS); primary assessment at 6 months as per main objective."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients who reach remission after 6, 12 and 24 months of treatment (DAS < 2,6).\n- Proportion of patients with low disease activity after 6 months of treatment (DAS < 3,2).\n- Proportion of patients for which a biologic treatment is introduced after 6, 12 and 24 months of treatment.\n- 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.\n- Proportion of patients who present a serious adverse event within the two groups during the 6 months of treatment.\n- Description of the evolution of functional assessment according to Health Assessment Questionnaire (HAQ) within the two groups during the 6 months of treatment.","definition_or_measurement_approach":"Remission and low disease activity assessed by DAS28 thresholds (DAS < 2.6 for remission; DAS < 3.2 for low disease activity) at 6, 12 and 24 months; biologic treatment introduction recorded at 6/12/24 months; metabolic parameters measured by clinical/lab assessments (weight, waist circumference, fasting glucose, HbA1c, lipids, insulinemia, bilirubin); safety assessed by occurrence of serious adverse events during 6 months; functional status assessed by Health Assessment Questionnaire (HAQ) over 6 months."}

France

Earliest CTIS Part Ii Submission Date

19-01-2024

Latest Decision Or Authorization Date

09-07-2024

Processing Time Days

172

Number Of Sites

10

Number Of Participants

128

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Bordeaux

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"Ministry for Health and Solidarity, France","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"NORDIC PHARMA SAS","duties_or_roles":"Monetary support","organisation_type":""}