Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-25 @ 6:09 AM
Study NCT ID:
NCT03106259
Status:
UNKNOWN
Last Update Posted:
2018-02-09
First Post:
2017-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj
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': 'ACTUAL', 'count': 9}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2021-03-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2017-04-03', 'studyFirstSubmitQcDate': '2017-04-06', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of FURESTEM-RA Inj.', 'timeFrame': '5 years', 'description': 'Evaluate the number of adverse events Safety of FURESTEM-RA Inj.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FURESTEM-RA'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.', 'detailedDescription': 'This is a observational study, single center, open label, study of safety of FURESTEM-RA Inj. in subjects with moderate to severe rheumatoid arthritis.\n\nSubjects participating in this observational study originally participated in study FURESTEM-RA Inj.\n\n\\[NCT02221258\\]'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects participating in this observational study originally participated in study FURESTEM-RA Inj. \\[NCT02221258\\]', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\\[NCT02221258\\]\n* Subject who understands and voluntarily sign an informed consent form\n\nExclusion Criteria:\n\n* In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period'}, 'identificationModule': {'nctId': 'NCT03106259', 'briefTitle': 'Long-term Observational Study to Evaluation the Safety of FURESTEM-RA Inj', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kang Stem Biotech Co., Ltd.'}, 'officialTitle': 'Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj', 'orgStudyIdInfo': {'id': 'KSTBT_FURESTEM_RA_EXT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-Interventional Study', 'description': 'Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.\\[NCT02221258\\]', 'interventionNames': ['Drug: FURESTEM-RA Inj.']}], 'interventions': [{'name': 'FURESTEM-RA Inj.', 'type': 'DRUG', 'otherNames': ['Not applicable-observational study'], 'description': 'Non-interventional observational study', 'armGroupLabels': ['Non-Interventional Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul national University Boramae medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ki-chul Shin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kang Stem Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}