Rebamipide in Patients With Active Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo patients will receive the standard therapy (methotrexate) plus placebo tablets |
Drug: Placebo
patients will receive the standard therapy (methotrexate) plus placebo tablets
|
| Experimental: rebamipide 100 mg rebamipide taken orally daily plus Methotrexate 7.5 mg weekly |
Drug: Rebamipide
patients will receive the standard therapy plus 100 mg Rebamipide three times daily
|
Outcome Measures
Primary Outcome Measures
- ACR20 [at baseline and at week 12]
based on tender and swollen joint counts, patient's assessment of pain
- Disease activity scale in 28 joints (DAS-28) [at baseline and at week 12]
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).
- ACR50 & ACR70 response rate [at baseline and at week 12]
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
Secondary Outcome Measures
- HAQ-DI (Health Assessment Score- Disability index) [at baseline and at week 12]
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
- TNF-α [at baseline and at week 12]
Serum level Tumor necrosis factor- alpha (TNF-α)
- IL-17 [at baseline and at week 12]
Serum levels of Interleukins (IL)
- CRP [at baseline and at week 12]
Serum level of C-reactive protein (CRP)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- October 6 University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PR-Ph