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Korean College of Rheumatology Biologics Registry (KOBIO)

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ClinicalTrials.gov Identifier: NCT01965132
Recruitment Status : Recruiting
First Posted : October 18, 2013
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Kichul Shin, Seoul National University Hospital

Brief Summary:
We plan to establish a nationwide Biologics Registry (in the form of an inception cohort) to study the safety profiles in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis patients receiving biologic agents.As this registry is to observe the "real world" use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is planned.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Drug: Biologic DMARD

Detailed Description:
This registry is a multi-centre, prospective, observational program that will gather and analyze data on patients being treated with biologics 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. There will be no additional visit or laboratory test done outside the routine clinical practice. Selection of biologic agent, dosing and treatment duration are at the discretion of the investigator. Informed consent will be obtained from the patient prior to the collection of any data.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Korean College of Rheumatology Biologics Registry
Actual Study Start Date : January 1, 2013
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023


Group/Cohort Intervention/treatment
Biologic DMARD
Korean patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis who will initiate, restart or switch to a biologic agent (etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab)
Drug: Biologic DMARD
Other Name: etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab




Primary Outcome Measures :
  1. Number of participants with adverse events during the use of biologics in Korean patients with Rheumatic diseases [ Time Frame: up to 5 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Inclusion Criteria:

  • Patients diagnosed with RA, AS or PsA
  • RA deemed by their rheumatologist to require treatment with a biologic or non-biologic DMARDs
  • AS or PsA patients who are to initiate, restart or switch to a biologic agent
  • 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 upon screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965132


Contacts
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Contact: Kichul Shin, MD kideb1@snu.ac.kr

Locations
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Korea, Republic of
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Contact: Kichul Shin, MD    +8228703204    kideb1@snu.ac.kr   
Principal Investigator: Kichul Shin, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Yeonguk Song, MD Seoul National University Hospital
Principal Investigator: Taehwan Kim, MD Hanyang University
Principal Investigator: Seunggi Kwak, MD THE CATHOLIC UNIV.OF KOREA SEOUL ST.MARY'S HOSPITAL
Principal Investigator: Sinseok Lee, MD Chonnam National University Hospital
Principal Investigator: Jaejun Lee, MD Samsung Medical Center
Principal Investigator: Changhun Lee, MD WONKWANG UNIV. HOSPITAL
Principal Investigator: Changgeun Lee, MD Asan Medical Center
Principal Investigator: Ran Song, MD KYUNG HEE NATIONAL MEDICAL CENTER
Principal Investigator: Donghyeok Shin, MD Eulji General Hospital
Principal Investigator: Changhee Seo, MD Ajou University School of Medicine
Principal Investigator: Sangil Lee, MD Gyeongsang National University Hospital
Principal Investigator: Jungyoon Choi, MD Daegu Catholic University Medical Center
Principal Investigator: Youngok Jung, MD Hallym University Kangnam Sacred Heart Hospital
Principal Investigator: Sungjae Choi, MD Korea University
Principal Investigator: Gowoon Joo, MD Inha University Hospital
Principal Investigator: Jimin Oh, MD SAM Medical Center
Principal Investigator: Heejung Ryu, 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: Juhyun Lee, MD Inje University
Principal Investigator: Soojin Yoo, MD Chungnam National University Hospital
Principal Investigator: Guiyoung Kang, MD THE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITAL
Principal Investigator: Youngho Lee, MD Korea University Guro Hospital
Principal Investigator: Sangwoo Im, MD Dong-A University Hospital
Principal Investigator: Sungkyu Kim, MD Daegu Catholic University Medical Center
Principal Investigator: Yongbum Park, MD Severance Hospital
Principal Investigator: Chanhong Jeon, MD Soonchunhyang University Hospital
Principal Investigator: Daehyun Yu, MD Hanyang University
Principal Investigator: Chanbum Choi, MD Hanyang University
Principal Investigator: Sanghun Lee, MD Konkuk University Medical Center
Principal Investigator: Youngmo Kang, MD Kyungpook National University Hospital
Principal Investigator: Jungsoo Song, MD Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Principal Investigator: Jisoo Lee, MD EWHA E-HOSPITAL
Principal Investigator: Sungwook Kang, MD Chungnam National University Hospital
Principal Investigator: Sungsoo Kim, MD Gangneung Asan Hospital
Principal Investigator: Yongwook Park, MD Chonnam National University Hospital
Principal Investigator: Kyunghee Jung, MD Inha University Hospital
Principal Investigator: Yujung Ha, MD Myongji Hospital
Principal Investigator: Jaebum Jeon, MD HANYANG UNIVERSITY HOSITAL
Principal Investigator: Eunbong Lee, MD Seoul National University Hospital

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kichul Shin, Director of KOBIO registry, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01965132     History of Changes
Other Study ID Numbers: KOBIO_1
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Kichul Shin, Seoul National University Hospital:
Rheumatiod Arhthritis
Ankylosing spondylitis
Psoriatic arthritis
Biologic agents
Cohort studies
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ankylosis
Adalimumab
Etanercept
Rituximab
Infliximab
Abatacept
Ustekinumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents