Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 8:06 PM
Study NCT ID:
NCT05166304
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2021-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rebamipide in Patients With Active Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052785', 'term': 'rebamipide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR20', 'timeFrame': 'at baseline and at week 12', 'description': "based on tender and swollen joint counts, patient's assessment of pain"}, {'measure': 'Disease activity scale in 28 joints (DAS-28)', 'timeFrame': 'at baseline and at week 12', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'HAQ-DI (Health Assessment Score- Disability index)', 'timeFrame': 'at baseline and at week 12', 'description': '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'}, {'measure': 'CRP', 'timeFrame': 'at baseline and at week 12', 'description': 'Serum level of C-reactive protein (CRP)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nrheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.\n\nExclusion Criteria:\n\n1. History of biological DMARDS.\n2. History of gastrointestinal surgery, GI ulceration,GI bleeding\n3. Intolerance or allergy to rebamibide or methotrexate\n4. Smoking or alcohol abuse\n5. Any changes in using medication (changing the dosage or type of medicines)\n6. Receive hormone replacement therapy, warfarin, and other anticoagulants'}, 'identificationModule': {'nctId': 'NCT05166304', 'briefTitle': 'Rebamipide in Patients With Active Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'MUFMIRB App N. 1007/12/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'patients will receive the standard therapy (methotrexate) plus placebo tablets', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'rebamipide', 'description': '100 mg rebamipide taken orally daily plus Methotrexate 15 mg weekly', 'interventionNames': ['Drug: Rebamipide']}], 'interventions': [{'name': 'Rebamipide', 'type': 'DRUG', 'description': 'patients will receive the standard therapy plus 100 mg Rebamipide three times daily', 'armGroupLabels': ['rebamipide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'patients will receive the standard therapy (methotrexate) plus placebo tablets', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Minya', 'country': 'Egypt', 'facility': 'Minia University', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Esraa Abdallah', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minia University'}, {'name': 'Engy Wahsh', 'role': 'STUDY_CHAIR', 'affiliation': 'October 6 University'}, {'name': 'Asmaa Elsayed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Minia University, faculty of medicine', 'class': 'UNKNOWN'}, {'name': 'Sohag University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of clinical pharmacy', 'investigatorFullName': 'engy wahsh', 'investigatorAffiliation': 'October 6 University'}}}}