Rebamipide in Patients With Active Rheumatoid Arthritis

Phase 1

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Rebamipide

• Registration Number: NCT05166304
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Status Verified: 2024-01
• Study Start: 2024-01-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-17
• Primary Completion: 2024-10-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	patients will receive the standard therapy (methotrexate) plus placebo tablets
rebamipide	Rebamipide	100 mg rebamipide taken orally daily plus Methotrexate 7.5 mg weekly

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Minia University; 🇪🇬 Minya, Egypt