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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01965132
Date of registration:	11/10/2013
Prospective Registration:	No
Primary sponsor:	Seoul National University Hospital
Public title:	Korean College of Rheumatology Biologics Registry KOBIO
Scientific title:	Korean College of Rheumatology Biologics Registry
Date of first enrolment:	January 1, 2013
Target sample size:	7000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT01965132
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Korea, Republic of

Contacts

Name:	Kichul Shin, MD
Address:
Telephone:
Email:	kideb1@snu.ac.kr
Affiliation:

Name:	Yongwook Park, MD
Address:
Telephone:
Email:
Affiliation:	Chonnam National University Hospital

Name:	Gowoon Joo, MD
Address:
Telephone:
Email:
Affiliation:	Inha University Hospital

Name:	Changhun Lee, MD
Address:
Telephone:
Email:
Affiliation:	WONKWANG UNIV. HOSPITAL

Name:	Sangwoo Im, MD
Address:
Telephone:
Email:
Affiliation:	Dong-A University Hospital

Name:	Taehwan Kim, MD
Address:
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Affiliation:	Hanyang University

Name:	Youngho Lee, MD
Address:
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Affiliation:	Korea University Guro Hospital

Name:	Youngmo Kang, MD
Address:
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Affiliation:	Kyungpook National University Hospital

Name:	Seunggi Kwak, MD
Address:
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Email:
Affiliation:	THE CATHOLIC UNIV.OF KOREA SEOUL ST.MARY'S HOSPITAL

Name:	Kichul Shin, MD
Address:
Telephone:	+8228703204
Email:	kideb1@snu.ac.kr
Affiliation:

Name:	Sinseok Lee, MD
Address:
Telephone:
Email:
Affiliation:	Chonnam National University Hospital

Name:	Soojin Yoo, MD
Address:
Telephone:
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Affiliation:	Chungnam National University Hospital

Name:	Jisoo Lee, MD
Address:
Telephone:
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Affiliation:	EWHA E-HOSPITAL

Name:	Jaebum Jeon, MD
Address:
Telephone:
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Affiliation:	HANYANG UNIVERSITY HOSITAL

Name:	Juhyun Lee, MD
Address:
Telephone:
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Affiliation:	Inje University

Name:	Sungjae Choi, MD
Address:
Telephone:
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Affiliation:	Korea University

Name:	Jimin Oh, MD
Address:
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Affiliation:	SAM Medical Center

Name:	Jungsoo Song, MD
Address:
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Affiliation:	Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Name:	Heejung Ryu, MD
Address:
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Affiliation:	Gachon University Gil Medical Center

Name:	Sungsoo Kim, MD
Address:
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Affiliation:	Gangneung Asan Hospital

Name:	Jinseok Kim, MD
Address:
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Affiliation:	Jeju National University Hospital

Name:	Mihye Kwon, MD
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Affiliation:	KONYANG UNIV. HOSPITAL

Name:	Changgeun Lee, MD
Address:
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Email:
Affiliation:	Asan Medical Center

Name:	Sungwook Kang, MD
Address:
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Affiliation:	Chungnam National University Hospital

Name:	Yeonguk Song, MD
Address:
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Affiliation:	Seoul National University Hospital

Name:	Donghyeok Shin, MD
Address:
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Affiliation:	Eulji General Hospital

Name:	Chanbum Choi, MD
Address:
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Affiliation:	Hanyang University

Name:	Eunbong Lee, MD
Address:
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Affiliation:	Seoul National University Hospital

Name:	Guiyoung Kang, MD
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Affiliation:	THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL

Name:	Changhee Seo, MD
Address:
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Affiliation:	Ajou University School of Medicine

Name:	Jungyoon Choi, MD
Address:
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Affiliation:	Daegu Catholic University Medical Center

Name:	Sungkyu Kim, MD
Address:
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Affiliation:	Daegu Catholic University Medical Center

Name:	Youngok Jung, MD
Address:
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Affiliation:	Hallym University Kangnam Sacred Heart Hospital

Name:	Kyunghee Jung, MD
Address:
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Affiliation:	Inha University Hospital

Name:	Sanghun Lee, MD
Address:
Telephone:
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Affiliation:	Konkuk University Medical Center

Name:	Ran Song, MD
Address:
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Affiliation:	KYUNG HEE NATIONAL MEDICAL CENTER

Name:	Chanhong Jeon, MD
Address:
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Affiliation:	Soonchunhyang University Hospital

Name:	Sangil Lee, MD
Address:
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Affiliation:	Gyeongsang National University Hospital

Name:	Daehyun Yu, MD
Address:
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Affiliation:	Hanyang University

Name:	Yujung Ha, MD
Address:
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Affiliation:	Myongji Hospital

Name:	Jaejun Lee, MD
Address:
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Affiliation:	Samsung Medical Center

Name:	Yongbum Park, MD
Address:
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Affiliation:	Severance Hospital

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Ankylosing Spondylitis

Psoriatic Arthritis

Intervention(s)

Drug: Biologic DMARD

Primary Outcome(s)

Number of participants with adverse events during the use of biologics in Korean patients with Rheumatic diseases [Time Frame: up to 10 years]

Secondary Outcome(s)

Secondary ID(s)

KOBIO_1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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