BridgeMD
Methotrexate and Metformin in rheumatoid arthritis patients.
EU CTIS ID: 2024-511033-35-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 β-HCG who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment.
You likely can't join if
- 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.
See the full eligibility 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 β-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).
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.