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OpenTrials
Completed

NCT Number: NCT05166304

Rebamipide 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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Minia University

Minya, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

rebamipide

Drug

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

Placebo

Drug

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

Primary outcomes

  1. ACR20

    Time frame: at baseline and at week 12

    based on tender and swollen joint counts, patient's assessment of pain

  2. Disease activity scale in 28 joints (DAS-28)

    Time frame: 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 outcomes

  1. HAQ-DI (Health Assessment Score- Disability index)

    Time frame: 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

  2. CRP

    Time frame: at baseline and at week 12

    Serum level of C-reactive protein (CRP)

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Minia University
  • Sohag University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2021
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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