Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-02 @ 8:13 AM
Study NCT ID:
NCT04134169
Status:
RECRUITING
Last Update Posted:
2022-10-10
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-04-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-07', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-10-18', 'lastUpdatePostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety Assessment', 'timeFrame': '5 years', 'description': '(Rate of Adverse Event, Number of Participants with Adverse Event)'}], 'secondaryOutcomes': [{'measure': '1. Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate', 'timeFrame': '5 years'}, {'measure': '2. Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate', 'timeFrame': '5 years'}, {'measure': 'change in DAS(Disease activity scores)28-ESR from baseline', 'timeFrame': '5 years', 'description': 'DAS range is from ≥ 3.2 (inactive) , \\>3.2 but ≤ 5.1(moderate), \\>5.1(very active)'}, {'measure': 'change in KHAQ(Korean Health assessment questionnaire) from baseline', 'timeFrame': '5 years', 'description': 'KHAQ range is from 0 (clear) to 60 (severe)'}, {'measure': 'change in CDAI (clinical disease activity index) from baseline', 'timeFrame': '5 years', 'description': 'CDAI range is from 0 (clear) to 76 (severe)'}, {'measure': 'change in 100mm Pain VAS(Visual analogue scale) from baseline', 'timeFrame': '5 years', 'description': '100mm Pain VAS range is from 0 (clear) to 100 (severe)'}, {'measure': 'change in Modified Sharp/Van der Heijde Socre from baseline', 'timeFrame': '5 years', 'description': 'Modified Sharp/Van der Heijde Socre range is from 0 (clear) to 448 (severe)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)', 'detailedDescription': 'A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis: 5-year Results From the K0202 Extension Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Moderate to Severe Rheumatoid arthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject who enrolled K0202 Clinical Trial(parent study) and has been given more than one medication.\n2. Subjects who understand and voluntarily sign an informed consent form\n\nExclusion Criteria:\n\n1\\. Any other condition which the investigator judges would make patient unsuitable for study participation'}, 'identificationModule': {'nctId': 'NCT04134169', 'briefTitle': 'Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj(K0202)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kang Stem Biotech Co., Ltd.'}, 'officialTitle': 'A Multi-center, Open, Long-term Follow-up Study to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis : 5-year Results From the K0202 Extension Study', 'orgStudyIdInfo': {'id': 'K0202-E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rheumatoid arthritis', 'interventionNames': ['Other: Not applicable(observational study)']}], 'interventions': [{'name': 'Not applicable(observational study)', 'type': 'OTHER', 'description': 'Not applicable(observational study)', 'armGroupLabels': ['Rheumatoid arthritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sanghui Kim', 'role': 'CONTACT', 'phone': '+82-2-8703969'}], 'facility': 'Seoul national University Boramae medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Chae Eun Jeon', 'role': 'CONTACT', 'email': 'cejeon@kangstem.com', 'phone': '+82-2-20367614'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kang Stem Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}