Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments (ADEM2)

Centre Hospitalier Universitaire de Nice

Status and phase

Not yet enrolling

Phase 3

Phase 2

Conditions

Erosive Hand Osteoarthritis

Treatments

Drug: Placebo

Drug: Methotrexate Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT07501507

2022-502362-24-00 (EU Trial (CTIS) Number)

21-API-03

Details and patient eligibility

About

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

Enrollment

170 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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,