Montelukast Use in Rheumatoid Arthritis

NCT05447520 | Completed Phase 2

• 1 other identifier: 2021-376
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  16 weeks

Study Arms (2)

Montelukast Group

EXPERIMENTAL

Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks.

Drug: Montelukast; Drug: Conventional DMARDs

Control Group

PLACEBO COMPARATOR

Patients will receive conventional DMARDs plus placebo tablet daily for 16 weeks

Drug: Placebo; Drug: Conventional DMARDs

Interventions

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

Montelukast Group

Placebo DRUG

Oral tablet once daily

Control Group

Conventional DMARDs DRUG

methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Control Group; Montelukast Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noha Mansour: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

• Noha Mansour

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: December 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

EG (1)