Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Erosive Hand Osteoarthritis

In brief

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

Key facts

Study ID

NCT07501507

Run by

Centre Hospitalier Universitaire de Nice

People needed

170

Starts

2026-05-02

Expected to finish

2027-10-01

Last updated by the study team

2026-03-30

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,

Where it is running

• CHU de Nice — Nice, France

Full record on ClinicalTrials.gov

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