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Recruiting

NCT Number: NCT01965132

Korean College of Rheumatology Biologics and Targeted Therapy Registry

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location status: Recruiting

Location contact

Kichul Shin, MD

CONTACT

[email protected]

+8228703204

Kichul Shin, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biologic or targeted synthetic DMARD

Drug

Other names: etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biosimilars, tofacitinib, baricitinib, upadacitinib

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keunyoung O

CONTACT

[email protected]

Kichul Shin, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Acronym: KOBIO

Important dates

Study start
2012
Primary completion
2029
Study completion
2030
First posted
Oct 18, 2013
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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