Clinical trial NCT01965132: Korean College of Rheumatology Biologics and Targeted Therapy Registry
Official title: Korean College of Rheumatology Biologics and Targeted Therapy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Keywords: Rheumatiod Arhthritis
Ankylosing spondylitis
Psoriatic arthritis
Biologic agents
Cohort studies
Small molecule agents
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the following disease who will initiate, restart or switch to a biologic agent or a targeted synthetic DMARD

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

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.

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

Primary outcomes:
measure: Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs in Korean patients with Rheumatic diseases
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Eun Yeong Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Tae-Hwan Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Shin-Seok Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SAMSUNG MEDICL CENTER
name: Jaejoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Changhoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Chang-Keun Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Hyoun-Ah Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyeongsang National University Hospital
name: Sang-Il Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daegu Catholic University Medical Center
name: Jung-Yoon Choe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Ansan Hospital
name: Jae Hyun Jung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gachon University Gil Medical Center
name: Mi Ryoung Seo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeju National University Hospital
name: Jinseok Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KONYANG UNIV. HOSPITAL
name: Mihye Kwon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Ilsan Paik Hospital
name: Joo-Hyun Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: Seong Wook Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL
name: Kwi Young Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: Sung Won Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Young-Beom Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Hyun-Sook Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hanyang University
name: Dae Hyun Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Konkuk University Medical Center
name: Sang-Heon Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Young Mo Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: KangWon National University Hospital
name: Ki Won Moon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyunghee University Medical Center
name: Seung-Jae Hong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyung University Dongsan Medical Center
name: Sang-Hyun Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Guro Hospital
name: Gwan Gyu Song, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Changwon Hospital
name: Jiwon Hwang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soonchunhyang University Hospital
name: Sung Hae Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungnam National University Hospital
name: JINHYUN KIM, MD
role: STUDY_DIRECTOR
affiliation: INJE UNIVERSITY ILSAN PAIK HOSPTIAL
name: Joo-Hyun Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Wan Hee Ryu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: In-Ah Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HALLYM UNIVERSITY HOSPITAL
name: Hyun Ah Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Kichul Shin, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.