Rebamipide in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166304
• Other study ID #: MUFMIRB App N. 1007/12/2023
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2024
• Est. completion date: November 1, 2024

Study information

• Verified date: January 2024
• Source: October 6 University
• Contact: Esraa Abdallah
• Phone: 01007065253
• Email: dr.esraa_fathy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Rebamipide
patients will receive the standard therapy plus 100 mg Rebamipide three times daily
• Placebo
patients will receive the standard therapy (methotrexate) plus placebo tablets

Locations

Country	Name	City	State
Egypt	Minia University	Minya

Sponsors (3)

Lead Sponsor	Collaborator
October 6 University	Minia University, faculty of medicine, Sohag University, Faculty of pharmacy

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20	based on tender and swollen joint counts, patient's assessment of pain	at baseline and at week 12
Primary	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	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
Secondary	CRP	Serum level of C-reactive protein (CRP)	at baseline and at week 12