Rebamipide in Patients With Active Rheumatoid Arthritis

NCT05166304 | Completed Phase 1

• 1 other identifier: MUFMIRB App N. 1007/12/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• HAQ-DI (Health Assessment Score- Disability index)

  at baseline and at week 12

• CRP

  at baseline and at week 12

Study Arms (2)

placebo

PLACEBO COMPARATOR

patients will receive the standard therapy (methotrexate) plus placebo tablets

Drug: Placebo

rebamipide

EXPERIMENTAL

100 mg rebamipide taken orally daily plus Methotrexate 15 mg weekly

Drug: Rebamipide

Interventions

Rebamipide DRUG

patients will receive the standard therapy plus 100 mg Rebamipide three times daily

rebamipide

Placebo DRUG

patients will receive the standard therapy (methotrexate) plus placebo tablets

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead
• Minia University, faculty of medicine: collaborator
• Sohag University: collaborator

Study Sites (1)

Minia University

Minya, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

rebamipide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Esraa Abdallah

  Minia University

  PRINCIPAL INVESTIGATOR

• Engy Wahsh

  October 6 University

  STUDY CHAIR

• Asmaa Elsayed

  Sohag University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of clinical pharmacy

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

EG (1)