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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:	6 May 2024
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 and Targeted Therapy Registry KOBIO
Scientific title:	Korean College of Rheumatology Biologics and Targeted Therapy Registry
Date of first enrolment:	December 1, 2012
Target sample size:	10000
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT01965132
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Korea, Republic of

Contacts

Name:	Seong Wook Kang, MD
Address:
Telephone:
Email:
Affiliation:	Chungnam National University Hospital

Name:	Tae-Hwan Kim, MD
Address:
Telephone:
Email:
Affiliation:	Hanyang University

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

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

Name:	Joo-Hyun Lee, MD
Address:
Telephone:
Email:
Affiliation:	Inje University Ilsan Paik Hospital

Name:	Mihye Kwon, MD
Address:
Telephone:
Email:
Affiliation:	KONYANG UNIV. HOSPITAL

Name:	Jae Hyun Jung, MD
Address:
Telephone:
Email:
Affiliation:	Korea University Ansan Hospital

Name:	Young Mo Kang, MD
Address:
Telephone:
Email:
Affiliation:	Kyungpook National University Hospital

Name:	Young-Beom Park, MD
Address:
Telephone:
Email:
Affiliation:	Severance Hospital

Name:	Shin-Seok Lee, MD
Address:
Telephone:
Email:
Affiliation:	Chonnam National University Hospital

Name:	In-Ah Choi, MD
Address:
Telephone:
Email:
Affiliation:	Chungbuk National University Hospital

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

Name:	Ki Won Moon, MD
Address:
Telephone:
Email:
Affiliation:	KangWon National University Hospital

Name:	Sang-Hyun Kim, MD
Address:
Telephone:
Email:
Affiliation:	Keimyung University Dongsan Medical Center

Name:	Jiwon Hwang, MD
Address:
Telephone:
Email:
Affiliation:	Samsung Changwon Hospital

Name:	Hyoun-Ah Kim, MD
Address:
Telephone:
Email:
Affiliation:	Ajou University School of Medicine

Name:	Mi Ryoung Seo, MD
Address:
Telephone:
Email:
Affiliation:	Gachon University Gil Medical Center

Name:	Jaejoon Lee, MD
Address:
Telephone:
Email:
Affiliation:	SAMSUNG MEDICL CENTER

Name:	Eun Yeong Lee, MD
Address:
Telephone:
Email:
Affiliation:	Seoul National University Hospital

Name:	Hyun-Sook Kim, MD
Address:
Telephone:
Email:
Affiliation:	Soonchunhyang University Hospital

Name:	Sung Won Lee, MD
Address:
Telephone:
Email:
Affiliation:	Dong-A University Hospital

Name:	Hyun Ah Kim, MD
Address:
Telephone:
Email:
Affiliation:	HALLYM UNIVERSITY HOSPITAL

Name:	Joo-Hyun Lee, MD
Address:
Telephone:
Email:
Affiliation:	INJE UNIVERSITY ILSAN PAIK HOSPTIAL

Name:	Kichul Shin, MD
Address:
Telephone:
Email:
Affiliation:	SMG-SNU Boramae Medical Center

Name:	Jung-Yoon Choe, MD
Address:
Telephone:
Email:
Affiliation:	Daegu Catholic University Medical Center

Name:	Dae Hyun Yu, MD
Address:
Telephone:
Email:
Affiliation:	Hanyang University

Name:	Kwi Young Kang, MD
Address:
Telephone:
Email:
Affiliation:	THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL

Name:	Changhoon Lee, MD
Address:
Telephone:
Email:
Affiliation:	Wonkwang University Hospital

Name:	Chang-Keun Lee, MD
Address:
Telephone:
Email:
Affiliation:	Asan Medical Center

Name:	Wan Hee Ryu, MD
Address:
Telephone:
Email:
Affiliation:	Chonbuk National University Hospital

Name:	Seung-Jae Hong, MD
Address:
Telephone:
Email:
Affiliation:	Kyunghee University Medical Center

Name:	JINHYUN KIM, MD
Address:
Telephone:
Email:
Affiliation:	Chungnam National University Hospital

Name:	Sang-Il Lee, MD
Address:
Telephone:
Email:
Affiliation:	Gyeongsang National University Hospital

Name:	Sang-Heon Lee, MD
Address:
Telephone:
Email:
Affiliation:	Konkuk University Medical Center

Name:	Gwan Gyu Song, MD
Address:
Telephone:
Email:
Affiliation:	Korea University Guro Hospital

Name:	Sung Hae Chang, MD
Address:
Telephone:
Email:
Affiliation:	Soonchunhyang University 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 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

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

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Rheumatoid Arthritis

Ankylosing Spondylitis

Intervention(s)

Drug: Biologic or targeted synthetic DMARD

Primary Outcome(s)

Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs 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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