Korean College of Rheumatology Biologics and Targeted Therapy Registry

NCT01965132 | Recruiting DMC FDA Drug

• 1 other identifier: KOBIO_1
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs in Korean patients with Rheumatic diseases

  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.

  up to 10 years

Study Arms (1)

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

Drug: Biologic or targeted synthetic DMARD

Interventions

Biologic or targeted synthetic DMARD DRUG

Also known as: etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biosimilars, tofacitinib, baricitinib, upadacitinib

Biologic or targeted synthetic DMARD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• RA, AS, PsA patients who are already on biologics or targeted synthetic DMARDs upon screening

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Related Publications (4)

• 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.

  PMID: 35996930 DERIVED

• 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.

  PMID: 32696266 DERIVED

• 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.

  PMID: 31734899 DERIVED

• 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.

  PMID: 31365335 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Interventions

Biological Products; Etanercept; Adalimumab; Infliximab; golimumab; tocilizumab; Abatacept; Rituximab; Ustekinumab; secukinumab; ixekizumab; Biosimilar Pharmaceuticals; tofacitinib; baricitinib; upadacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoconjugates; Antibodies, Monoclonal, Murine-Derived

Study Officials

• Eun Yeong Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Tae-Hwan Kim, MD

  Hanyang University

  PRINCIPAL INVESTIGATOR

• Shin-Seok Lee, MD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Jaejoon Lee, MD

  SAMSUNG MEDICL CENTER

  PRINCIPAL INVESTIGATOR

• Changhoon Lee, MD

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

• Chang-Keun Lee, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Hyoun-Ah Kim, MD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

• Sang-Il Lee, MD

  Gyeongsang National University Hospital

  PRINCIPAL INVESTIGATOR

• Jung-Yoon Choe, MD

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

• Jae Hyun Jung, MD

  Korea University Ansan Hospital

  PRINCIPAL INVESTIGATOR

• Mi Ryoung Seo, 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

• Joo-Hyun Lee, MD

  Inje University Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

• Seong Wook Kang, MD

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Kwi Young Kang, MD

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

  PRINCIPAL INVESTIGATOR

• Sung Won Lee, MD

  Dong-A University Hospital

  PRINCIPAL INVESTIGATOR

• Young-Beom Park, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Hyun-Sook Kim, MD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• Dae Hyun Yu, MD

  Hanyang University

  PRINCIPAL INVESTIGATOR

• Sang-Heon Lee, MD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

• Young Mo Kang, MD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

• Ki Won Moon, MD

  KangWon National University Hospital

  PRINCIPAL INVESTIGATOR

• Seung-Jae Hong, MD

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

• Sang-Hyun Kim, MD

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

• Gwan Gyu Song, MD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

• Jiwon Hwang, MD

  Samsung Changwon Hospital

  PRINCIPAL INVESTIGATOR

• Sung Hae Chang, MD

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

• JINHYUN KIM, MD

  Chungnam National University Hospital

  STUDY DIRECTOR

• Joo-Hyun Lee, MD

  INJE UNIVERSITY ILSAN PAIK HOSPTIAL

  PRINCIPAL INVESTIGATOR

• Wan Hee Ryu, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• In-Ah Choi, MD

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Hyun Ah Kim, MD

  HALLYM UNIVERSITY HOSPITAL

  PRINCIPAL INVESTIGATOR

• Kichul Shin, MD

  SMG-SNU Boramae Medical Center

  STUDY CHAIR

Central Study Contacts

Kichul Shin, MD

CONTACT

kideb1@snu.ac.kr

Keunyoung O

CONTACT

yo8313@hanmail.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, KOBIO registry

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: December 1, 2012
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)