Montelukast Use in Rheumatoid Arthritis

Noha Mansour

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Montelukast; Drug: Placebo; Drug: Conventional DMARDs

Study type: Interventional

Funder types: Other

Identifiers

NCT05447520

2021-376

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Montelukast Group

Experimental group

Description:

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

Treatment:

Drug: Montelukast

Drug: Conventional DMARDs

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Conventional DMARDs