Korean College of Rheumatology Biologics Registry (KOBIO)

• ClinicalTrials.gov Identifier: NCT01965132
• Recruitment Status: Recruiting
• First Posted: October 18, 2013
• Last Update Posted: March 24, 2020
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Kichul Shin, Seoul National University Hospital

Study Description

Brief Summary:

We plan to establish a nationwide Biologics Registry (in the form of an inception cohort) to study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis patients receiving biologic agents.As this registry is to observe the "real world" use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is planned.

Condition or disease	Intervention/treatment
Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis	Drug: Biologic DMARD

Detailed Description:

This registry is a multi-centre, prospective, observational program that will gather and analyze data on patients being treated with biologics 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. There will be no additional visit or laboratory test done outside the routine clinical practice. Selection of biologic agent, dosing and treatment duration are at the discretion of the investigator. Informed consent will be obtained from the patient prior to the collection of any data.

Study Design

• 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

Groups and Cohorts

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)	Drug: Biologic DMARD; Other Name: etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• 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

Study Population

Patients of the following disease who will initiate, restart or switch to a biologic agent

1. Rheumatoid arthritis (RA)
2. Ankylosing spondylitis (AS)
3. Psoriatic arthritis (PsA)

Criteria

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

Contacts and Locations

Contacts

Contact: Kichul Shin, MD; kideb1@snu.ac.kr

Locations

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

Sponsors and Collaborators

Seoul National University Hospital

Investigators

• 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

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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. Epub 2019 Jul 19.

• 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
• 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

Keywords provided by Kichul Shin, Seoul National University Hospital:

Rheumatiod Arhthritis; Ankylosing spondylitis; Psoriatic arthritis; Biologic agents; Cohort studies

Additional relevant MeSH terms:

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