Montelukast Use in Rheumatoid Arthritis

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Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Montelukast

Placebo

Conventional DMARDs

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Montelukast Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05447520

First Posted

July 1, 2022

Last Updated

February 12, 2023

Sponsor

Noha Mansour

1. Study Identification

Unique Protocol Identification Number

NCT05447520

Brief Title

Montelukast Use in Rheumatoid Arthritis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2022 (Actual)

Primary Completion Date

March 2023 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Noha Mansour

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Montelukast Group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral tablet once daily

Intervention Type

Drug

Intervention Name(s)

Conventional DMARDs

Intervention Description

methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

Primary Outcome Measure Information:

Title

Disease activity score in 28 joints (DAS-28)

Description

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.

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Basma Sayed Ahmed

Phone

+201207753307

Email

basma_mohamed@mans.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noha Mansour

Organizational Affiliation

Mansoura University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura University

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

Individual Site Status

Recruiting

Rheumatoid Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial