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NCT07501507
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Conditions: Erosive Hand Osteoarthritis
Sex: All
Ages: 40 Years – 85 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 170
Sponsor: Centre Hospitalier Universitaire de Nice
Location: CHU de Nice Nice
Summary
Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis
Eligibility Criteria
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,
Source: ClinicalTrials.gov (NCT07501507). StuddyBuddy aggregates publicly available trial information.