Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments: A Randomised, Double-blind, Placebo-controlled Trial

Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis

Inclusion Criteria:

- Digital osteoarthritis (IPD and IPP) according to ACR criteria (with an X-ray of the hands taken less than 3 months ago, showing at least 3 joints with digital osteoarthritis KL>=2) and symptomatic for more than three months

Exclusion Criteria:

• Having a bilirubin level > 5 mg/dl (85.5 µmol/l)
• Pregnant or breastfeeding women (a urine pregnancy test will be performed on women of childbearing age),
• Injection of hyaluronic acid within the previous 6 months,
• Injection of cortisone derivatives within the previous 3 months,
• Presence of psoriasis,
• Inflammatory rheumatism,
• Microcrystalline arthropathy,
• Joint prosthesis in one of the joints of the hand,
• Planned placement of a joint prosthesis in the hand during the study period,
• Major progressive disease (life-threatening cardiovascular disease, hematopoietic cancers including myeloma, cancers with risk of bone metastases),
• Liver failure.
• Severe renal failure (creatinine clearance less than 50 ml/min).
• Positive hepatitis B serology.
• Tuberculosis, hepatitis C, HIV positive, or other immunodeficiency syndromes.
• Uncontrolled infections.
• Use of corticosteroids.
• Use of morphine derivatives,
• Taking Bactrim,
• Taking high doses of aspirin (greater than or equal to 500mg/day),
• Contraindications to the use of methotrexate,