Skip to main content
OpenTrials
Completed

NCT Number: NCT05447520

Montelukast Use in Rheumatoid Arthritis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Montelukast

Drug

Montelukast 10 mg oral tablet once daily for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2

Placebo

Drug

Oral tablet once daily

Conventional DMARDs

Drug

methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Primary outcomes

  1. Disease activity score in 28 joints (DAS-28)

    Time frame: 16 weeks

    Scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , CRP levels ,and patient self-assessment of his condition (global health assessment) . Whereas "28" describes the number of different joints including in the measurement :proximal interphalangeal joints (10 joints),metacarpophalangeal joints (10),wrists (2),elbows (2),shoulders (2),knees (2).

    A DAS-28 value < 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value >5.1 corresponds to a high disease activity.

Secondary outcomes

  1. Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI)

    Time frame: 16 weeks

    It comprises eight categories assessing the ability of patients to perform activities of daily living. Each category includes two or three questions scored from 0 (without any difficulty) to 3 (unable to do).

    • The score of each category is the highest score among the scores of the included questions.
    • If an aid or assistance device is used or if help is required from another individual, then the minimum score for that section is 2.
    • The final score is calculated by summation of the scores for various categories divided by the number of categories.
    • Resulting in a score from 0 to 3.

Sponsors and collaborators

Lead sponsor

Noha Mansour

Other

Registry information

Official study title

Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.