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Recruiting NCT01965132

Korean College of Rheumatology Biologics and Targeted Therapy Registry

— Observational Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biologic or targeted synthetic DMARD.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Biologic or targeted synthetic DMARD

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Seoul Metropolitan Government-Seoul National University Boramae Medical Center — Seoul

Publications

  • Yeo J, Kim JY, Park JK, Shin K, Lee EY, Kim TH, Park JW. Flare prediction after tapering the dose of tumour necrosis factor inhibitors in patients with axial spondyloarthritis: a nationwide cohort study. Rheumatology (Oxford). 2025 Mar 1;64(3):1155-1161. doi: 10.1093/rheumatology/keae138. PMID 38479822
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT01965132 · KOBIO_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗