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Not yet recruiting NCT07501507

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

Phase II / Phase III Interventional Erosive Hand Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methotrexate Injectable Solution, Placebo.
Who it may be relevant to
Registry conditions: Erosive Hand Osteoarthritis. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Methotrexate Injectable Solution
    Injection of methotrexate every week during 12 month
  • Drug Placebo
    The placebo consists of a 0.9% solution of sodium chloride (NaCl) in sterile distilled water for injection. This solution was chosen as the placebo. Injection every week during 12 month.

Primary outcome measures

  • Structural lesion [Time frame: 12 months]
Secondary outcome measures (2)
  • Function [Time frame: 12 months]
  • Effectiveness of the treatment on pain [Time frame: 12 months]

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Nice — Nice

Identifiers

NCT: NCT07501507 · 21-API-03 · 2022-502362-24-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗