Trial record 2 of 7 for:
enbrel | Recruiting, Not yet recruiting Studies | Ankylosing Spondylitis
Korean College of Rheumatology Biologics Registry (KOBIO)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01965132 |
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Recruitment Status :
Recruiting
First Posted : October 18, 2013
Last Update Posted : June 6, 2018
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Sponsor:
Seoul National University Hospital
Information provided by (Responsible Party):
Kichul Shin, Seoul National University Hospital
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
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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)
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Drug: Biologic DMARD
Other Name: etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab |
Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis (AS)
- 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
| Contact: Kichul Shin, MD | kideb1@snu.ac.kr |
Locations
| 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
| 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):
| 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 |
| 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:
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Rheumatiod Arhthritis Ankylosing spondylitis Psoriatic arthritis Biologic agents Cohort studies |
Additional relevant MeSH terms:
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Spondylitis Spondylitis, Ankylosing Etanercept Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Psoriasis Skin Diseases, Papulosquamous |
Skin Diseases Ankylosis Adalimumab Rituximab Infliximab Abatacept Ustekinumab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Anti-Inflammatory Agents Dermatologic Agents Gastrointestinal Agents |