Montelukast Use in Rheumatoid Arthritis

• Sponsor: Noha Mansour (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05447520
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 9.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Montelukast; Drug: Placebo; Drug: Conventional DMARDs	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Montelukast in Rheumatoid Arthritis Patients
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Montelukast Group Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 12 weeks.	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; Drug: Conventional DMARDs; methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
Placebo Comparator: Control Group Patients will receive conventional DMARDs plus placebo tablet daily for 12 weeks	Drug: Placebo; Oral tablet once daily; Drug: Conventional DMARDs; methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Outcome Measures

Primary Outcome Measures

1. Disease activity score in 28 joints (DAS-28) [12 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 Outcome Measures

1. Assessment of patient's QOL using Health Assessment Questionnaire Disability index (HAQ-DI) [12 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura		Egypt	35516

Sponsors and Collaborators

• Noha Mansour

Investigators

• Principal Investigator: Noha Mansour, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Noha Mansour, Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department, Mansoura University
• ClinicalTrials.gov Identifier: NCT05447520
• Other Study ID Numbers: 2021-376
• First Posted: Jul 7, 2022
• Last Update Posted: Jul 7, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Montelukast

Study Results

No Results Posted as of Jul 7, 2022