Methotrexate in hand osteoarthritis that hasn’t improved with usual treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized,-placebo controlled phase 2/3 trial evaluating the structural effects of injectable methotrexate in digital osteoarthritis of the hands. Participants have digital OA in at least three joints (KL score ≥2) and symptoms for more than three months. The study compares methotrexate injectable solution to placebo, with safety and joint structure as key outcomes. It is conducted at CHU de Nice in Nice, France, under the lead sponsorship of Centre Hospitalier Universitaire de Nice.

Why it matters

Who can join: the full rules

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,

Where it's running

• CHU de Nice
  Nice, France Recruiting

Study contacts

• Principal investigator: Yacine ALLAM, Dr — Centre Hospitalier Universitaire de Nice
• Study coordinator: Christian ROUX, Pr
• Email: roux.c@chu-nice.fr
• Phone: 492035512

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

• Anti-CD25 antibody to prevent acute GVHD after haploidentical stem cell transplant

  This study tests whether an anti-CD25 antibody can better prevent acute graft-versus-host disease after haploidentical hematopoietic stem cell transplantation compared with the usual methotrexate-based approach.

  Recruiting Phase 3 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07689630

• R-PMDT Regimen for Newly Diagnosed PCNSL

  This study tests the R-PMDT treatment approach in people newly diagnosed with primary CNS lymphoma to see how many respond.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07604987

• Intrathecal methotrexate-loaded tumor-derived vesicles for leptomeningeal lung cancer

  This treatment will try giving methotrexate-loaded tumor-derived vesicles into the spinal fluid to see if it is safe and helps adults with leptomeningeal metastasis from lung cancer who have not responded to standard treatments.

  Recruiting Phase 1/2 Henan Cancer Hospital · Zhengzhou, Henan · NCT07559097

• Subcutaneous methotrexate for Chinese adults with rheumatoid arthritis

  This project will test how well and how safely subcutaneous methotrexate works for Chinese adults with rheumatoid arthritis, including people with lung or coronary comorbidities.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07463937

• Repinatrabit's effects on common medicines like birth control, metformin, carbamazepine, rosuvastatin, and methotrexate

  This trial will test whether repinatrabit changes how common medicines—ethinyl estradiol/norethindrone (birth control), metformin, carbamazepine, rosuvastatin, and methotrexate—act in healthy adults.

  Recruiting Phase 1 Otsuka Pharmaceutical Development & Commercialization, Inc. · Melbourne, Victoria · NCT07446400

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.