Korean College of Rheumatology Biologics Registry (KOBIO)
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ClinicalTrials.gov Identifier: NCT01965132 |
Recruitment Status :
Recruiting
First Posted : October 18, 2013
Last Update Posted : March 24, 2020
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Condition or disease | Intervention/treatment |
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Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis | Drug: Biologic DMARD |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 7000 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | Korean College of Rheumatology Biologics Registry |
Actual Study Start Date : | January 1, 2013 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | June 30, 2025 |

Group/Cohort | Intervention/treatment |
---|---|
Biologic DMARD
Korean patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis who will initiate, restart or switch to a biologic agent (etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab)
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Drug: Biologic DMARD
Other Name: etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab |
- Number of participants with adverse events during the use of biologics in Korean patients with Rheumatic diseases [ Time Frame: up to 10 years ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients of the following disease who will initiate, restart or switch to a biologic agent
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis (AS)
- Psoriatic arthritis (PsA)
Inclusion Criteria:
- Patients diagnosed with RA, AS or PsA
- RA deemed by their rheumatologist to require treatment with a biologic or non-biologic DMARDs
- AS or PsA patients who are to initiate, restart or switch to a biologic agent
- Patients who provide a written consent of participating in this registry (data collection and review).
Exclusion Criteria:
- RA, AS, PsA patients who are already on biologics upon screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965132
Contact: Kichul Shin, MD | kideb1@snu.ac.kr |
Korea, Republic of | |
SMG-SNU Boramae Medical Center | Recruiting |
Seoul, Korea, Republic of, 07061 | |
Contact: Kichul Shin, MD +8228703204 kideb1@snu.ac.kr | |
Principal Investigator: Kichul Shin, MD |
Principal Investigator: | Yeonguk Song, MD | Seoul National University Hospital | |
Principal Investigator: | Taehwan Kim, MD | Hanyang University | |
Principal Investigator: | Seunggi Kwak, MD | THE CATHOLIC UNIV.OF KOREA SEOUL ST.MARY'S HOSPITAL | |
Principal Investigator: | Sinseok Lee, MD | Chonnam National University Hospital | |
Principal Investigator: | Jaejun Lee, MD | Samsung Medical Center | |
Principal Investigator: | Changhun Lee, MD | WONKWANG UNIV. HOSPITAL | |
Principal Investigator: | Changgeun Lee, MD | Asan Medical Center | |
Principal Investigator: | Ran Song, MD | KYUNG HEE NATIONAL MEDICAL CENTER | |
Principal Investigator: | Donghyeok Shin, MD | Eulji General Hospital | |
Principal Investigator: | Changhee Seo, MD | Ajou University School of Medicine | |
Principal Investigator: | Sangil Lee, MD | Gyeongsang National University Hospital | |
Principal Investigator: | Jungyoon Choi, MD | Daegu Catholic University Medical Center | |
Principal Investigator: | Youngok Jung, MD | Hallym University Kangnam Sacred Heart Hospital | |
Principal Investigator: | Sungjae Choi, MD | Korea University | |
Principal Investigator: | Gowoon Joo, MD | Inha University Hospital | |
Principal Investigator: | Jimin Oh, MD | SAM Medical Center | |
Principal Investigator: | Heejung Ryu, 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: | Juhyun Lee, MD | Inje University | |
Principal Investigator: | Soojin Yoo, MD | Chungnam National University Hospital | |
Principal Investigator: | Guiyoung Kang, MD | THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL | |
Principal Investigator: | Youngho Lee, MD | Korea University Guro Hospital | |
Principal Investigator: | Sangwoo Im, MD | Dong-A University Hospital | |
Principal Investigator: | Sungkyu Kim, MD | Daegu Catholic University Medical Center | |
Principal Investigator: | Yongbum Park, MD | Severance Hospital | |
Principal Investigator: | Chanhong Jeon, MD | Soonchunhyang University Hospital | |
Principal Investigator: | Daehyun Yu, MD | Hanyang University | |
Principal Investigator: | Chanbum Choi, MD | Hanyang University | |
Principal Investigator: | Sanghun Lee, MD | Konkuk University Medical Center | |
Principal Investigator: | Youngmo Kang, MD | Kyungpook National University Hospital | |
Principal Investigator: | Jungsoo Song, MD | Chung-Ang University Hosptial, Chung-Ang University College of Medicine | |
Principal Investigator: | Jisoo Lee, MD | EWHA E-HOSPITAL | |
Principal Investigator: | Sungwook Kang, MD | Chungnam National University Hospital | |
Principal Investigator: | Sungsoo Kim, MD | Gangneung Asan Hospital | |
Principal Investigator: | Yongwook Park, MD | Chonnam National University Hospital | |
Principal Investigator: | Kyunghee Jung, MD | Inha University Hospital | |
Principal Investigator: | Yujung Ha, MD | Myongji Hospital | |
Principal Investigator: | Jaebum Jeon, MD | HANYANG UNIVERSITY HOSITAL | |
Principal Investigator: | Eunbong Lee, MD | Seoul National University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Kichul Shin, Director of KOBIO registry, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01965132 |
Other Study ID Numbers: |
KOBIO_1 |
First Posted: | October 18, 2013 Key Record Dates |
Last Update Posted: | March 24, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Rheumatiod Arhthritis Ankylosing spondylitis Psoriatic arthritis Biologic agents Cohort studies |
Spondylitis Spondylitis, Ankylosing Etanercept Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Psoriasis Skin Diseases, Papulosquamous |
Skin Diseases Ankylosis Adalimumab Infliximab Abatacept Ustekinumab Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |