Montelukast Use in Rheumatoid Arthritis

Last updated: February 10, 2024
Sponsor: Noha Mansour
Overall Status: Completed

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Rheumatoid Arthritis

Musculoskeletal Diseases

Treatment

Montelukast

Conventional DMARDs

Placebo

Clinical Study ID

NCT05447520
2021-376
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Montelukast is widely used in patients with asthma. Several preclinical data suggest that it could be repositioned as novel strategy for managing rheumatic patients by decreasing inflammatory mediators.

Considering the probable enhanced antiarthritic effects of montelukast; it could be hypothesized that its adjuvant use might improve treatment outcomes in rheumatic patients who remain poorly controlled despite initial optimal guidelines directed medical treatment. Therefore, this study aims to evaluate the potential added benefits of montelukast use in conjunction with csDMARDs in RA patients with moderate and high disease activity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients ages ≥ 18 years old.
  • Patients diagnosed with RA according to American College of Rheumatology/Europeanleague Against Rheumatism (ACR/ EULAR) 2010 criteria (25) presented with diseaseactivity 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 3months.

Exclusion

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 uppernormal limits).
  • Patients with impaired kidney (estimated glomerular filtration rate (eGFR) < 30ml/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 articularcorticosteroides,
  • Smokers.

Study Design

Total Participants: 92
Treatment Group(s): 3
Primary Treatment: Montelukast
Phase: 2
Study Start date:
December 15, 2021
Estimated Completion Date:
December 30, 2022

Connect with a study center

  • Mansoura University

    Mansoura, 35516
    Egypt

    Site Not Available

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