Rebamipide in Patients With Active Rheumatoid Arthritis

October 6 University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Rebamipide

Study type: Interventional

Funder types: Other

Identifiers

NCT05166304

MUFMIRB App N. 1007/12/2023

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

rebamipide

Experimental group

Description:

100 mg rebamipide taken orally daily plus Methotrexate 7.5 mg weekly

Treatment:

Drug: Rebamipide