Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-22 @ 2:49 AM
Study NCT ID:
NCT01965132
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2013-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korean College of Rheumatology Biologics and Targeted Therapy Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], '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'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D000068800', 'term': 'Etanercept'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'C529000', 'term': 'golimumab'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D000069594', 'term': 'Abatacept'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D000069549', 'term': 'Ustekinumab'}, {'id': 'C555450', 'term': 'secukinumab'}, {'id': 'C549079', 'term': 'ixekizumab'}, {'id': 'D059451', 'term': 'Biosimilar Pharmaceuticals'}, {'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'C000613732', 'term': 'upadacitinib'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D018796', 'term': 'Immunoconjugates'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2013-10-11', 'studyFirstSubmitQcDate': '2013-10-15', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs in Korean patients with Rheumatic diseases', 'timeFrame': 'up to 10 years', 'description': 'Patient will be followed on a yearly basis. Adverse events based on MedDRA® during the observational period will be filled out on each follow up. Adverse events will also be assessed in the case of switching or discontinuation of biologics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rheumatiod Arhthritis', 'Ankylosing spondylitis', 'Psoriatic arthritis', 'Biologic agents', 'Cohort studies', 'Small molecule agents'], 'conditions': ['Rheumatoid Arthritis', 'Ankylosing Spondylitis', 'Psoriatic Arthritis']}, 'referencesModule': {'references': [{'pmid': '35996930', 'type': 'DERIVED', 'citation': 'Kim HA, Lee E, Park SY, Lee SS, Shin K. Clinical Characteristics of Patients With Psoriatic Spondylitis Versus Those With Ankylosing Spondylitis: Features at Baseline Before Biologic Therapy. J Korean Med Sci. 2022 Aug 22;37(33):e253. doi: 10.3346/jkms.2022.37.e253.'}, {'pmid': '32696266', 'type': 'DERIVED', 'citation': 'Kim HA, Lee E, Lee SK, Park YB, Shin K. Retention Rate and Efficacy of the Biosimilar CT-P13 Versus Reference Infliximab in Patients with Ankylosing Spondylitis: A Propensity Score-Matched Analysis from the Korean College of Rheumatology Biologics Registry. BioDrugs. 2020 Aug;34(4):529-539. doi: 10.1007/s40259-020-00432-z.'}, {'pmid': '31734899', 'type': 'DERIVED', 'citation': 'Kim HA, Lee E, Lee SK, Park YB, Lee YN, Kang HJ, Shin K. Retention Rate and Safety of Biosimilar CT-P13 in Rheumatoid Arthritis: Data from the Korean College of Rheumatology Biologics Registry. BioDrugs. 2020 Feb;34(1):89-98. doi: 10.1007/s40259-019-00393-y.'}, {'pmid': '31365335', 'type': 'DERIVED', 'citation': 'Kim HA, Lee E, Lee SK, Park YB, Lee YN, Kang HJ, Shin K. Retention rate and long-term safety of biosimilar CT-P13 in patients with ankylosing spondylitis: data from the Korean College of Rheumatology Biologics registry. Clin Exp Rheumatol. 2020 Mar-Apr;38(2):267-274. doi: 10.55563/clinexprheumatol/z0va6o. Epub 2019 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'We established a nationwide biologics and targeted synthetic DMARDs registry (in the form of an inception cohort) to study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis patients receiving biologics or targeted synthetic DMARDs. As this registry is to observe the "real world" use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is planned.', 'detailedDescription': 'This registry is a multi-center, prospective, observational program that will gather and analyze data on patients being treated with biologics and targeted synthetic DMARDs in Korea. In contrast to a controlled clinical trial, there is no imposed experimental intervention and solely the patients\' physicians will determine the patient\'s treatment. Thus, the data captured and reported in this registry will reflect a "real world" approach to the treatment with biologics or targeted synthetic DMARDs. There will be no additional visit or laboratory test done outside the routine clinical practice. The selection of the agent, dosing, and treatment duration is determined by the investigator. Informed consent will be obtained from the patient prior to the collection of any data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the following disease who will initiate, restart or switch to a biologic agent or a targeted synthetic DMARD\n\n1. Rheumatoid arthritis (RA)\n2. Ankylosing spondylitis (AS)\n3. Psoriatic arthritis (PsA)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with RA, AS or PsA\n* RA deemed by their rheumatologist to require treatment with a biologic or targeted synthetic DMARDs or a conventional DMARD(s)\n* AS or PsA patients who are to initiate, restart or switch to a biologic agent or a targeted synthetic DMARD\n* Patients who provide a written consent of participating in this registry (data collection and review).\n\nExclusion Criteria:\n\n* RA, AS, PsA patients who are already on biologics or targeted synthetic DMARDs upon screening'}, 'identificationModule': {'nctId': 'NCT01965132', 'acronym': 'KOBIO', 'briefTitle': 'Korean College of Rheumatology Biologics and Targeted Therapy Registry', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Korean College of Rheumatology Biologics and Targeted Therapy Registry', 'orgStudyIdInfo': {'id': 'KOBIO_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biologic or targeted synthetic DMARD', 'description': 'Korean patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis who will initiate, restart or switch to a biologic agent (etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biolsimilars) or a targeted synthetic DMARD', 'interventionNames': ['Drug: Biologic or targeted synthetic DMARD']}], 'interventions': [{'name': 'Biologic or targeted synthetic DMARD', 'type': 'DRUG', 'otherNames': ['etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biosimilars', 'tofacitinib, baricitinib, upadacitinib'], 'armGroupLabels': ['Biologic or targeted synthetic DMARD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kichul Shin, MD', 'role': 'CONTACT', 'email': 'kideb1@snu.ac.kr', 'phone': '+8228703204'}, {'name': 'Kichul Shin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Metropolitan Government-Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kichul Shin, MD', 'role': 'CONTACT', 'email': 'kideb1@snu.ac.kr'}, {'name': 'Keunyoung O', 'role': 'CONTACT', 'email': 'yo8313@hanmail.net'}], 'overallOfficials': [{'name': 'Eun Yeong Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Tae-Hwan Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Shin-Seok Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonnam National University Hospital'}, {'name': 'Jaejoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SAMSUNG MEDICL CENTER'}, {'name': 'Changhoon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang University Hospital'}, {'name': 'Chang-Keun Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Hyoun-Ah Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}, {'name': 'Sang-Il Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gyeongsang National University Hospital'}, {'name': 'Jung-Yoon Choe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Daegu Catholic University Medical Center'}, {'name': 'Jae Hyun Jung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Ansan Hospital'}, {'name': 'Mi Ryoung Seo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gachon University Gil Medical Center'}, {'name': 'Jinseok Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jeju National University Hospital'}, {'name': 'Mihye Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KONYANG UNIV. HOSPITAL'}, {'name': 'Joo-Hyun Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University Ilsan Paik Hospital'}, {'name': 'Seong Wook Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National University Hospital'}, {'name': 'Kwi Young Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL"}, {'name': 'Sung Won Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}, {'name': 'Young-Beom Park, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Severance Hospital'}, {'name': 'Hyun-Sook Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'Dae Hyun Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hanyang University'}, {'name': 'Sang-Heon Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Medical Center'}, {'name': 'Young Mo Kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}, {'name': 'Ki Won Moon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KangWon National University Hospital'}, {'name': 'Seung-Jae Hong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyunghee University Medical Center'}, {'name': 'Sang-Hyun Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Keimyung University Dongsan Medical Center'}, {'name': 'Gwan Gyu Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Guro Hospital'}, {'name': 'Jiwon Hwang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Changwon Hospital'}, {'name': 'Sung Hae Chang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'JINHYUN KIM, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chungnam National University Hospital'}, {'name': 'Joo-Hyun Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'INJE UNIVERSITY ILSAN PAIK HOSPTIAL'}, {'name': 'Wan Hee Ryu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chonbuk National University Hospital'}, {'name': 'In-Ah Choi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungbuk National University Hospital'}, {'name': 'Hyun Ah Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HALLYM UNIVERSITY HOSPITAL'}, {'name': 'Kichul Shin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, KOBIO registry', 'investigatorFullName': 'Kichul Shin', 'investigatorAffiliation': 'SMG-SNU Boramae Medical Center'}}}}