Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGRebamipide
patients will receive the standard therapy plus 100 mg Rebamipide three times daily
DRUGPlacebo
patients will receive the standard therapy (methotrexate) plus placebo tablets
Sponsors
Minia University, faculty of medicine
Sohag University
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
1. History of biological DMARDS. 2. History of gastrointestinal surgery, GI ulceration,GI bleeding 3. Intolerance or allergy to rebamibide or methotrexate 4. Smoking or alcohol abuse 5. Any changes in using medication (changing the dosage or type of medicines) 6. Receive hormone replacement therapy, warfarin, and other anticoagulants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| CRP | at baseline and at week 12 | Serum level of C-reactive protein (CRP) |
Countries
Egypt
Outcome results
None listed