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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Farmalider S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05], Diseases [C] - Immune System Diseases [C20]

Trial duration

30 Jan 2026 → ongoing

Decision date (initial)

2025-10-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Farmalider S.A.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

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).

Conditions and MedDRA coding

Erosive/inflammatory osteoarthritis of the hands

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients who provide written informed consent (IC) and are able to comply with all scheduled visits and procedures required by the study.
2. Patients ≥ 18 years at the screening visit.
3. Patients with erosive osteoarthritis of the interphalangeal joints of the hand with significant clinical activity according to Anandarajah criteria (Anandarajah, A. 2010).
4. Patients with VAS pain at rest of the most affected hand ≥ 50 mm at baseline visit.
5. 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.

Exclusion criteria 22

1. History of fibromyalgia and/or chronic fatigue syndrome.
2. Patient being treated with any other medication contraindicated due to risk of interactions with study medication.
3. 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.
4. Patient with a history of allergy or hypersensitivity to the study medication, rescue medication or any of its excipients.
5. Patient intolerant to study medication due to galactose intolerance, lactase insufficiency, or glucose-galactose malabsorption.
6. Pregnant or lactating women.
7. 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.
8. 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.
9. Patients with scheduled surgery during the clinical trial.
10. History of drug or alcohol abuse during the 12 months prior to the baseline visit.
11. 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.
12. 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.
13. Patients who, in the opinion of the investigator, are unable or not willing to comply with study and follow-up procedures.
14. 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).
15. Patient with a BMI ≥ 35 kg/m2.
16. Pain in another part of the body that could interfere with the evaluation and results of the study according to investigator criteria.
17. 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.
18. Patients who have used intra-articular hyaluronic acid (in the study hand) during the 24 weeks prior to the baseline visit.
19. Patient undergoing radioactive synoviorthesis (in the study hand).
20. Patient being treated with other disease-modifying anti-rheumatic biological drugs.
21. 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”.
22. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in pain intensity (PID) at rest of the most affected hand with respect to baseline pain at 24 weeks of treatment with Montelukast xx mg, compared to placebo, measured through the VAS.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Farmalider S.A.

Sponsor organisation

Farmalider S.A.

Address

Calle De La Granja 1 Planta 3

City

Alcobendas

Postcode

28108

Country

Spain

Scientific contact point

Organisation

Farmalider S.A.

Contact name

Carlos Calandria

Public contact point

Organisation

Farmalider S.A.

Contact name

Carlos Calandria

Third parties 1

Locations

3 EU/EEA countries · 22 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications