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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast Group | Experimental | Patients will receive conventional DMARDs plus montelukast 10 mg tablet once daily for 16 weeks. |
|
| Control Group | Placebo Comparator | Patients will receive conventional DMARDs plus placebo tablet daily for 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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).
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noha Mansour | Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | 35516 | Egypt |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Placebo | Drug | Oral tablet once daily |
|
| Conventional DMARDs | Drug | methotrexate, leflunomide, hydroxychloroquine or sulfasalazine |
|
| 16 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |