Montelukast Use in Rheumatoid Arthritis

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Conventional DMARDs; Drug: Montelukast; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 35516
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast Group; Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks.	Drug: Conventional DMARDs; methotrexate, leflunomide, hydroxychloroquine or sulfasalazine; Drug: Montelukast; 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 Comparator: Control Group; Patients will receive conventional DMARDs plus placebo tablet daily for 16 weeks	Drug: Conventional DMARDs; methotrexate, leflunomide, hydroxychloroquine or sulfasalazine; Drug: Placebo; Oral tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity score in 28 joints (DAS-28)	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.	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI)	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.	16 weeks

Collaborators and Investigators

• Sponsor: Noha Mansour
• Investigators: Principal Investigator: Noha Mansour, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 2021-376

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No