Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT05447520
Eligibility Criteria:
Inclusion Criteria:
* Adult patients ages ≥ 18 years old.
* Patients diagnosed with RA according to American College of Rheumatology/European league Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with disease activity score-28 based on C-reactive protein (CRP) levels (DAS-28-CRP) \>3.2.
* Patient received stable regimen of one or more csDMARDs for at least the past 3 months.
Exclusion Criteria:
* Patient taking biological DMARDs.
* Known hypersensitivity to montelukast.
* Patients receive montelukast for any other indications.
* Patients with impaired liver functions (liver transaminases level ≥ three times upper normal limits).
* Patients with impaired kidney (estimated glomerular filtration rate (eGFR) \< 30 ml/min).
* Pregnancy and lactation.
* Patients with active or severe infections.
* Patients with other inflammatory or autoimmune diseases and malignancies.
* Patients with any psychiatric disorder.
* Patients taking IV, IM, orally (dose \> 10 mg daily) or intra articular corticosteroides,
* Smokers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05447520
Study Brief:
Protocol Section:
NCT05447520