RANDOMISED, MULTICENTRE, DOUBLE-BLIND CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MONTELUKAST VS. PLACEBO IN PATIENTS WITH EROSIVE/INFLAMMATORY OSTEOARTHRITIS OF THE HANDS. MOTHER Study.

A vizsgálat adatai

Ki végzi

Farmalider S.A.

Azonosító

EU 2025-521802-17-00

A regiszteradat frissítve

2026. augusztus 13.

Eredeti leírás

The primary objective of the study is to evaluate the difference in pain intensity at rest of the most affected hand with respect to baseline pain at 24 weeks of treatment with Montelukast xx mg, compared to placebo, in patients with erosive hand osteoarthritis (EHOA), using the Visual Analogue Scale (VAS).A teljes eredeti leírásKevesebb

The primary objective of the study is to evaluate the difference in pain intensity at rest of the most affected hand with respect to baseline pain at 24 weeks of treatment with Montelukast xx mg, compared to placebo, in patients with erosive hand osteoarthritis (EHOA), using the Visual Analogue Scale (VAS).

Bevonási feltételek: Patients who provide written informed consent (IC) and are able to comply with all scheduled visits and procedures required by the study; Patients ≥ 18 years at the screening visit; Patients with erosive osteoarthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah criteria (Anandarajah, A. 2010); Patients with VAS pain at rest of the most affected hand ≥ 50 mm at baseline visit; Patients with repercussion in functionality of the most affected hand evaluated with a score ≥1 in the question number 4 (Are you able to lift a full bottle with the hand?) of the FIHOA questionnaire at baseline visit.

Kizáró feltételek: History of drug or alcohol abuse during the 12 months prior to the baseline visit; Patient with a history of concurrent rheumatic articular diseases (history and/or current presence of signs) that could lead to a misinterpretation or interfere in the evaluation of efficacy in pain, such as chondrocalcinosis, Paget's disease of the ipsilateral extremity in relation to the affected hand, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis and disease Inflammatory bowel (Crohn's disease or Ulcerative Colitis); Patient taking corticosteroids (oral or injectable) within 4 weeks prior to the baseline visit, or methotrexate, hydroxychloroquine or SYSADOAs (Slow-Acting Drugs for the Symptomatic Treatment of Osteoarthritis) within 12 weeks prior to the baseline visit; Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the baseline visit; Patient being treated with any other medication contraindicated due to risk of interactions with study medication; Patient being treated with other disease-modifying anti-rheumatic biological drugs; Patients undergoing physical therapy or active physical rehabilitation (individual or group) treatment, are exposed to electrotherapy procedures or physical therapies, including specifically: Magnetotherapy, Therapeutic Ultrasound, Transcutaneous Electrical Stimulation (TENS), during the entire period of study participation; Patient being treated with NSAIDs and/or analgesics (except paracetamol) or colchicine within 7 days prior to the baseline visit. The use of paracetamol will be allowed up to 24 hours prior to the start of study treatment; Patient currently included in or who have participated in a clinical trial with medicines or health products in the 3 months prior to the baseline visit; Patients with scheduled surgery during the clinical trial; History of fibromyalgia and/or chronic fatigue syndrome; Patients with any contraindication related to the performance of the MRI test, including: • Pacemakers or neurostimulators, • Metal plates or fragments not attached to the bone in risk areas, newly implanted heart valves or intracranial clips. • Claustrophobia. • Weight more than 120 kg. • Intolerance to paramagnetic contrast; Patient with pathologies that according to medical criteria discourage their participation in the study, such as severe heart disease, liver failure, kidney failure, active malignancies, poorly controlled endocrine-metabolic diseases, coagulopathies, active gastrointestinal ulceration, active infection, epilepsy, and immunocompromised patients; Patient with poorly controlled neuropsychiatric diseases evaluated with a score ≥ 10 in PHQ-9 questionnaire or score diferent than 0 in question 9 “Thoughts that you would be better off dead or of hurting yourself in some way”; Patient with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients; Patient intolerant to study medication due to galactose intolerance, lactase insufficiency, or glucose-galactose malabsorption; Women of childbearing age and sexually active (excluded from this definition are women whose date of last menstruation is greater than one year from inclusion in this study and those who have undergone a tubal ligation or hysterectomy), who do not agree to take acceptable contraceptive measures during the clinical trial. Contraceptive measures include barrier methods, hormonal contraception, intrauterine device (IUD), or sexual abstinence. The investigator is responsible for determining whether the subject has adequate birth control for study participation; Patients who, in the opinion of the investigator, are unable or not willing to comply with study and follow-up procedures; Patient with a BMI ≥ 35 kg/m2; Pain in another part of the body that could interfere with the evaluation and results of the study according to investigator criteria; Patient undergoing radioactive synoviorthesis (in the study hand); Pregnant or lactating women.

EU CTIS 2025-521802-17-00