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| Name | Class |
|---|---|
| Minia University | OTHER |
| Sohag University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | patients will receive the standard therapy (methotrexate) plus placebo tablets |
|
| rebamipide | Experimental | 100 mg rebamipide taken orally daily plus Methotrexate 15 mg weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rebamipide | Drug | patients will receive the standard therapy plus 100 mg Rebamipide three times daily |
|
| 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 |
| 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 |
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Inclusion Criteria:
rheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esraa Abdallah | Minia University | Principal Investigator |
| Engy Wahsh | October 6 University | Study Chair |
| Asmaa Elsayed | Sohag University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University | Minya | 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 |
|---|---|
| C052785 | rebamipide |
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| Placebo | Drug | patients will receive the standard therapy (methotrexate) plus placebo tablets |
|
| CRP | Serum level of C-reactive protein (CRP) | at baseline and at week 12 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |