Rebamipide in Patients With Active Rheumatoid Arthritis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: Rebamipide

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Esraa Abdallah; Phone Number: 01007065253; Email: dr.esraa_fathy@yahoo.com

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • Minia University
    • Contact: Esraa Abdallah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

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
CRP	Serum level of C-reactive protein (CRP)	at baseline and at week 12

Collaborators and Investigators

• Sponsor: October 6 University
• Collaborators: Minia University, faculty of medicine; Sohag University, Faculty of pharmacy
• Investigators: Principal Investigator: Esraa Abdallah, Minia University; Study Chair: Engy Wahsh, October 6 University; Study Director: Asmaa Elsayed, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Protective Agents; Anti-Ulcer Agents; Antioxidants; Rebamipide
• Other Study ID Numbers: MUFMIRB App N. 1007/12/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No