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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologic or targeted synthetic DMARD | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biologic or targeted synthetic DMARD | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs in Korean patients with Rheumatic diseases | 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. | up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients of the following disease who will initiate, restart or switch to a biologic agent or a targeted synthetic DMARD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kichul Shin, MD | Contact | kideb1@snu.ac.kr | ||
| Keunyoung O | Contact | yo8313@hanmail.net |
| Name | Affiliation | Role |
|---|---|---|
| Eun Yeong Lee, MD | Seoul National University Hospital | Principal Investigator |
| Tae-Hwan Kim, MD | Hanyang University | Principal Investigator |
| Shin-Seok Lee, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Metropolitan Government-Seoul National University Boramae Medical Center | Recruiting | Seoul | 07061 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38479822 | Derived | Yeo J, Kim JY, Park JK, Shin K, Lee EY, Kim TH, Park JW. Flare prediction after tapering the dose of tumour necrosis factor inhibitors in patients with axial spondyloarthritis: a nationwide cohort study. Rheumatology (Oxford). 2025 Mar 1;64(3):1155-1161. doi: 10.1093/rheumatology/keae138. | |
| 35996930 | Derived |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D001688 | Biological Products |
| D000068800 | Etanercept |
| D000068879 | Adalimumab |
| D000069285 | Infliximab |
| C529000 | golimumab |
| C502936 | tocilizumab |
| D000069594 | Abatacept |
| D000069283 | Rituximab |
| D000069549 | Ustekinumab |
| C555450 | secukinumab |
| C549079 | ixekizumab |
| D059451 | Biosimilar Pharmaceuticals |
| C479163 | tofacitinib |
| C000596027 | baricitinib |
| C000613732 | upadacitinib |
| ID | Term |
|---|---|
| D045424 | Complex Mixtures |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
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| Chonnam National University Hospital |
| Principal Investigator |
| Jaejoon Lee, MD | SAMSUNG MEDICL CENTER | Principal Investigator |
| Changhoon Lee, MD | Wonkwang University Hospital | Principal Investigator |
| Chang-Keun Lee, MD | Asan Medical Center | Principal Investigator |
| Hyoun-Ah Kim, MD | Ajou University School of Medicine | Principal Investigator |
| Sang-Il Lee, MD | Gyeongsang National University Hospital | Principal Investigator |
| Jung-Yoon Choe, MD | Daegu Catholic University Medical Center | Principal Investigator |
| Jae Hyun Jung, MD | Korea University Ansan Hospital | Principal Investigator |
| Mi Ryoung Seo, MD | Gachon University Gil Medical Center | Principal Investigator |
| Jinseok Kim, MD | Jeju National University Hospital | Principal Investigator |
| Mihye Kwon, MD | KONYANG UNIV. HOSPITAL | Principal Investigator |
| Joo-Hyun Lee, MD | Inje University Ilsan Paik Hospital | Principal Investigator |
| Seong Wook Kang, MD | Chungnam National University Hospital | Principal Investigator |
| Kwi Young Kang, MD | THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL | Principal Investigator |
| Sung Won Lee, MD | Dong-A University Hospital | Principal Investigator |
| Young-Beom Park, MD | Severance Hospital | Principal Investigator |
| Hyun-Sook Kim, MD | Soonchunhyang University Hospital | Principal Investigator |
| Dae Hyun Yu, MD | Hanyang University | Principal Investigator |
| Sang-Heon Lee, MD | Konkuk University Medical Center | Principal Investigator |
| Young Mo Kang, MD | Kyungpook National University Hospital | Principal Investigator |
| Ki Won Moon, MD | KangWon National University Hospital | Principal Investigator |
| Seung-Jae Hong, MD | Kyunghee University Medical Center | Principal Investigator |
| Sang-Hyun Kim, MD | Keimyung University Dongsan Medical Center | Principal Investigator |
| Gwan Gyu Song, MD | Korea University Guro Hospital | Principal Investigator |
| Jiwon Hwang, MD | Samsung Changwon Hospital | Principal Investigator |
| Sung Hae Chang, MD | Soonchunhyang University Hospital | Principal Investigator |
| JINHYUN KIM, MD | Chungnam National University Hospital | Study Director |
| Joo-Hyun Lee, MD | INJE UNIVERSITY ILSAN PAIK HOSPTIAL | Principal Investigator |
| Wan Hee Ryu, MD | Chonbuk National University Hospital | Principal Investigator |
| In-Ah Choi, MD | Chungbuk National University Hospital | Principal Investigator |
| Hyun Ah Kim, MD | HALLYM UNIVERSITY HOSPITAL | Principal Investigator |
| Kichul Shin, MD | SMG-SNU Boramae Medical Center | Study Chair |
| 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. |
| 32696266 | Derived | 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. |
| 31734899 | Derived | 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. |
| 31365335 | Derived | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D018796 | Immunoconjugates |
| D058846 | Antibodies, Monoclonal, Murine-Derived |