Rheumatoid ArthritisPhase 1/2NCT05166304
Rebamipide in Patients With Active Rheumatoid Arthritis
A Phase 1/2 study testing Rebamipide in people with Rheumatoid Arthritis, run by October 6 University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rebamipide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rebamipide as an Adjunct to Methotrexate 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rebamipide, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebamipideDrug
patients will receive the standard therapy plus 100 mg Rebamipide three times daily
PlaceboDrug
patients will receive the standard therapy (methotrexate) plus placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | patients will receive the standard therapy (methotrexate) plus placebo tablets Receives: Drug: Placebo |
| rebamipide | Experimental | 100 mg rebamipide taken orally daily plus Methotrexate 15 mg weekly Receives: Drug: Rebamipide |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20
based on tender and swollen joint counts, patient's assessment of pain
Measured: 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).
Measured: at baseline and at week 12
Secondary outcomes (2)
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
Measured: at baseline and at week 12
CRP
Serum level of C-reactive protein (CRP)
Measured: at baseline and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jan 2024
- Primary completion1 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Minia University, Sohag University
- Responsible party
- Principal investigator, engy wahsh, October 6 University
- Investigators
- Esraa Abdallah, Principal investigator, Minia UniversityEngy Wahsh, Study chair, October 6 UniversityAsmaa Elsayed, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166304
- Sponsor's protocol ID
- MUFMIRB App N. 1007/12/2023
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05166304
- Acronym / sponsor ID
- MUFMIRB App N. 1007/12/2023
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Minia University, Sohag University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebopatients will receive the standard therapy (methotrexate) plus placebo tablets |
| rebamipide | Experimental | Drug: Rebamipide100 mg rebamipide taken orally daily plus Methotrexate 15 mg weekly |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebamipidepatients will receive the standard therapy plus 100 mg Rebamipide three times daily | Drug | rebamipide |
| Placebopatients will receive the standard therapy (methotrexate) plus placebo tablets | Drug | placebo |
Primary outcome
ACR20
Time frame: at baseline and at week 12
based on tender and swollen joint counts, patient's assessment of pain
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).
2 secondary outcomes
HAQ-DI (Health Assessment Score- Disability index)
Time frame: at baseline and at week 12
CRP
Time frame: at baseline and at week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esraa Abdallah principal investigator
Minia University
Engy Wahsh study chair
October 6 University
Asmaa Elsayed study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rebamipide in people with Rheumatoid Arthritis, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR20 (time frame: at baseline and at week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.