NCT05447520

Montelukast Use in Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Noha Mansour · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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	Placebo	Oral tablet once daily
DRUG	Conventional DMARDs	methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-07-07
• Last updated: 2024-02-13

Locations

1 site across 1 country: Egypt