Korean College of Rheumatology Biologics and Targeted Therapy Registry

NCT ID: NCT01965132

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-01
• Study Completion Date: 2030-06-30

Brief Summary

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.

Detailed Description

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.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Biologic or targeted synthetic DMARD

Intervention Type: DRUG

Interventions

Biologic or targeted synthetic DMARD

Intervention Type: DRUG

Other Intervention Names

etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biosimilars; tofacitinib, baricitinib, upadacitinib

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with RA, AS or PsA
• RA deemed by their rheumatologist to require treatment with a biologic or targeted synthetic DMARDs or a conventional DMARD(s)
• AS or PsA patients who are to initiate, restart or switch to a biologic agent or a targeted synthetic DMARD
• 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 or targeted synthetic DMARDs upon screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kichul Shin

Director, KOBIO registry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eun Yeong Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Tae-Hwan Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Shin-Seok Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Jaejoon Lee, MD

Role: PRINCIPAL_INVESTIGATOR

SAMSUNG MEDICL CENTER

Changhoon Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University Hospital

Chang-Keun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Hyoun-Ah Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Sang-Il Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Gyeongsang National University Hospital

Jung-Yoon Choe, MD

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Jae Hyun Jung, MD

Role: PRINCIPAL_INVESTIGATOR

Korea University Ansan Hospital

Mi Ryoung Seo, MD

Role: PRINCIPAL_INVESTIGATOR

Gachon University Gil Medical Center

Jinseok Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Jeju National University Hospital

Mihye Kwon, MD

Role: PRINCIPAL_INVESTIGATOR

KONYANG UNIV. HOSPITAL

Joo-Hyun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University Ilsan Paik Hospital

Seong Wook Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Chungnam National University Hospital

Kwi Young Kang, MD

Role: PRINCIPAL_INVESTIGATOR

THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL

Sung Won Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Dong-A University Hospital

Young-Beom Park, MD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Hyun-Sook Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Dae Hyun Yu, MD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Sang-Heon Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University Medical Center

Young Mo Kang, MD

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Ki Won Moon, MD

Role: PRINCIPAL_INVESTIGATOR

KangWon National University Hospital

Seung-Jae Hong, MD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Sang-Hyun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Gwan Gyu Song, MD

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Jiwon Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Changwon Hospital

Sung Hae Chang, MD

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

JINHYUN KIM, MD

Role: STUDY_DIRECTOR

Chungnam National University Hospital

Joo-Hyun Lee, MD

Role: PRINCIPAL_INVESTIGATOR

INJE UNIVERSITY ILSAN PAIK HOSPTIAL

Wan Hee Ryu, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

In-Ah Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Hyun Ah Kim, MD

Role: PRINCIPAL_INVESTIGATOR

HALLYM UNIVERSITY HOSPITAL

Kichul Shin, MD

Role: STUDY_CHAIR

SMG-SNU Boramae Medical Center

Locations

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Kichul Shin, MD

Role: CONTACT

kideb1@snu.ac.kr

Keunyoung O

Role: CONTACT

yo8313@hanmail.net

Facility Contacts

Kichul Shin, MD

Role: primary

kideb1@snu.ac.kr

+8228703204

References

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.

Reference Type: DERIVED

PMID: 35996930 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32696266 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31734899 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31365335 (View on PubMed)

Other Identifiers

KOBIO_1

Identifier Type: -

Identifier Source: org_study_id