Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT07273760
Status:
COMPLETED
Last Update Posted:
2025-12-10
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543529', 'term': 'vedolizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'targetDuration': '52 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-11-25', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Clinical Response at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Clinical response is defined as a decrease from baseline in HBI score of ≥3 points in CD participants and a decrease from baseline in Mayo Score of ≥3 points, ≥30%, and either a decrease from baseline in the rectal bleeding sub score of ≥ 1 or a rectal bleeding sub score of 0 or 1 in UC participants.'}], 'secondaryOutcomes': [{'measure': 'Safety Assessment During 52 Weeks', 'timeFrame': 'Up to 52 weeks', 'description': 'Safety assessment, including the incidence of AEs. All AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events are graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs is assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation is assessed based on the World Health Organization (WHO) criteria.'}, {'measure': 'Percentage of Participants Achieving Clinical Remission at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Clinical remission is defined as a HBI score of \\<5 points in CD participants and a Mayo Score of ≤2 points and no sub score of \\>1 in UC participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vedolizumab', 'IBD', 'Ulcerative Colitis', "Crohn's disease", 'Inflammatory Bowel Disease'], 'conditions': ['Ulcerative Colitis (UC)', 'Crohn Disease (CD)', 'Inflammatory Bowel Disease (IBD)']}, 'referencesModule': {'references': [{'pmid': '23964932', 'type': 'RESULT', 'citation': 'Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.'}, {'pmid': '38658485', 'type': 'RESULT', 'citation': "Yarur A, Mantzaris GJ, Wang S, Adsul S, Kamble P, Cook E, Sajeev G, Guerin A, Bressler B. Stratified Patient Profiling for Vedolizumab Effectiveness in Crohn's Disease: Identifying Optimal Subgroups for Enhanced Treatment Response in the EVOLVE Study. Adv Ther. 2024 Jun;41(6):2324-2341. doi: 10.1007/s12325-024-02825-w. Epub 2024 Apr 24."}], 'seeAlsoLinks': [{'url': 'https://link.springer.com/article/10.1007/s12325-024-02825-w', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to evaluate Effectiveness and safety of VedAryo® (Vedolizumab) in male or female participants with clinical diagnosis of Inflammatory Bowel Disease. The main questions are aim to answer:\n\n1. Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease?\n2. Is VedAryo® (Vedolizumab) safe in the treatment of Inflammatory Bowel Disease?\n\nIn this study, there is no comparison group. Participants received VedAryo® (Vedolizumab)', 'detailedDescription': "This research was conducted as a phase IV, post-marketing, observational cohort study, in which VedAryo® (Vedolizumab) was prescribed as part of routine clinical practice, and no study-related intervention was introduced. The study aimed to evaluate the real-world effectiveness and safety of VedAryo® in Iranian patients diagnosed with Inflammatory Bowel Disease (IBD).\n\nThe primary objective was to assess the effectiveness of VedAryo® based on clinical response, measured using the Mayo Scoring Index for ulcerative colitis and the Harvey-Bradshaw Index for Crohn's disease during the observation period.\n\nThe secondary objective focused on safety, including the incidence of adverse events (AEs) and serious adverse events (SAEs) recorded over the 52-week observational follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with Inflammatory bowel disease, including Ulcerative Colitis and Crohn's disease\n* Patients with an indication of vedolizumab therapy\n* Ability to comprehend and willingness to sign the informed consent form for this study."}, 'identificationModule': {'nctId': 'NCT07273760', 'briefTitle': 'VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AryoGen Pharmed Co.'}, 'officialTitle': 'A Prospective and Observational Study for Effectiveness and Safety Evaluation of VedAryo® (Vedolizumab) in Patients With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'VDZ.ARY.HV.IV.02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants received VedAryo® (Vedolizumab)', 'interventionNames': ['Drug: Vedolizumab']}], 'interventions': [{'name': 'Vedolizumab', 'type': 'DRUG', 'description': 'Vedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks', 'armGroupLabels': ['Participants received VedAryo® (Vedolizumab)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shiraz', 'state': 'Fars', 'country': 'Iran', 'facility': 'Dr. Mohammad-Javad Kaviani Clinic', 'geoPoint': {'lat': 29.61031, 'lon': 52.53113}}, {'city': 'Rasht', 'state': 'Gilan Province', 'country': 'Iran', 'facility': 'Gilan Gastroenterology and Hepatology Subspecialty Clinic', 'geoPoint': {'lat': 37.27611, 'lon': 49.58862}}, {'city': 'Mashhad', 'state': 'Razavi Khorasan Province', 'country': 'Iran', 'facility': 'Dr. Ali Beheshti-Namdar Clinic', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}, {'city': 'Mashhad', 'state': 'Razavi Khorasan Province', 'country': 'Iran', 'facility': 'Dr. Hassan Vossoughinia Clinic', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Dr. Hamid Asadzadeh Aghdaei Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Dr. Mahtab Shabani Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Dr. Naser Ebrahimi Daryani Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Imam Khomeini Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Mehr Specialty Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Professor Shahram Agah Gastroenterology, Hepatology, and Endoscopy Subspecialty Clinic', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Shariati Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}, {'city': 'Tehran', 'country': 'Iran', 'facility': 'Taleghani Hospital', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data produced in the present study are available upon reasonable request from the investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AryoGen Pharmed Co.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}