Using Rebamipide to Treat Active Rheumatoid Arthritis

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

Phase1; Phase2 Interventional October 6 University · NCT05166304

This study is testing if Rebamipide, a medication usually used for stomach issues, can help people with active rheumatoid arthritis feel better when added to their current treatment.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment50 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorOctober 6 University Academic / other
Drugs / interventionsmethotrexate
Locations1 site (Minya)
Trial IDNCT05166304 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of Rebamipide, an antiulcer medication, on patients with active rheumatoid arthritis (RA). The study aims to assess how Rebamipide can inhibit interleukin-17 and improve disease symptoms in individuals who have been on standard therapy for RA. Participants will be randomly assigned to receive either Rebamipide or a placebo, with their disease activity monitored throughout the trial. The study is designed to evaluate both the safety and efficacy of Rebamipide in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults with active rheumatoid arthritis who have been on standard therapy for at least three months.

Not a fit: Patients with a history of biological DMARDs or gastrointestinal issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from active rheumatoid arthritis.

How similar studies have performed: While the use of Rebamipide in this context is novel, other studies have explored IL-17 inhibition in RA with varying degrees of success.

Eligibility criteria

Show full inclusion / exclusion criteria
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

Where this trial is running

Minya

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Rheumatoid Arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.