Rebamipide in Patients With Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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Although the aetiology of RA remains to be fully elucidated, interleukin (IL)-17 are believed to play a critical role in the pathogenesis of RA. Rebamipide is an antiulcer drug that protects gastric epithelial cells,improves gastric defense mechanisms by increasing gastric mucus. Rebamipide inhibited interleukin (IL)-17, also it inhibits IL-1β-induced RASF proliferation.

Official Title
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Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Rebamipide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with active rheumatoid arthritis (disease activity score-28 joints: DAS-28 > 3.2) based on the 2010 American College of Rheumatology (ACR) criteria16 were recruited. rheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months. Exclusion Criteria: History of biological DMARDS. History of gastrointestinal surgery, GI ulceration,GI bleeding Intolerance or allergy to rebamibide or methotrexate Smoking or alcohol abuse Any changes in using medication (changing the dosage or type of medicines) Receive hormone replacement therapy, warfarin, and other anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>patients will receive the standard therapy (methotrexate) plus placebo tablets | Drug: Placebo<br>* patients will receive the standard therapy (methotrexate) plus placebo tablets<br>|
| Experimental: rebamipide<br>100 mg rebamipide taken orally daily plus Methotrexate 7.5 mg weekly | Drug: Rebamipide<br>* patients will receive the standard therapy plus 100 mg Rebamipide three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR20 | based on tender and swollen joint counts, patient's assessment of pain | at baseline and at week 12 | 
| Disease activity scale in 28 joints (DAS-28) | Scale assessing severity of rheumatoid arthritis based on number of tender, swollen joints, erythrocyte sedimentation rate (ESR) 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). | at baseline and at week 12 | 
| ACR50 & ACR70 response rate | based on tender and swollen joint counts, patient's assessment of pain, patient and physician global assessment of arthritis, Health Assessment Questionnaire Disability Index (HAQ DI), and CRP level | at baseline and at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAQ-DI (Health Assessment Score- Disability index) | HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section | at baseline and at week 12 | 
| TNF-α | Serum level Tumor necrosis factor- alpha (TNF-α) | at baseline and at week 12 | 
| IL-17 | Serum levels of Interleukins (IL) | at baseline and at week 12 | 
| CRP | Serum level of C-reactive protein (CRP) | at baseline and at week 12 |