Montelukast Use in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05447520
• Other study ID #: 2021-376
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
Oral tablet once daily
• Conventional DMARDs
methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Noha Mansour

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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