Korean College of Rheumatology Biologics and Targeted Therapy Registry (KOBIO)

April 24, 2024 updated by: Kichul Shin, Seoul National University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • Seoul Metropolitan Government-Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Kichul Shin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other Names:
  • etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biosimilars
  • tofacitinib, baricitinib, upadacitinib

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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: 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: 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
  • Study Director: JINHYUN KIM, MD, Chungnam National University Hospital
  • Principal Investigator: 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
  • Study Chair: Kichul Shin, MD, SMG-SNU Boramae Medical Center
  • Principal Investigator: Jae Hyun Jung, MD, Korea University Ansan Hospital
  • Principal Investigator: Joo-Hyun Lee, MD, Inje University Ilsan Paik Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KOBIO_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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