Rheumatoid ArthritisKOBIONCT01965132
Korean College of Rheumatology Biologics and Targeted Therapy Registry
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- What is being tested?
- Biologic or targeted synthetic DMARD
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2012to 30 Jun 2030
- How long will I take part?
- 15 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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).
Who cannot join
- RA, AS, PsA patients who are already on biologics or targeted synthetic DMARDs upon screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kichul Shin, MD contact
Keunyoung O contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul Metropolitan Government-Seoul National University Boramae Medical Center
Seoul, 07061
Kichul Shin, MD, +8228703204, kideb1@snu.ac.kr
Kichul Shin, MD
About this study
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.
Read the 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.
- Being tested
- Biologic or targeted synthetic DMARD
- Keywords
- Rheumatiod Arhthritis, Ankylosing spondylitis, Psoriatic arthritis, Biologic agents, Cohort studies, Small molecule agents
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic or targeted synthetic DMARDDrug
Also called etanercept, adalimumab, infliximab, golimumab, tocilizumab, abatacept, rituximab, ustekinumab, secukinumab, ixekizumab, or biosimilars, tofacitinib, baricitinib, upadacitinib
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Biologic or targeted synthetic DMARD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs in Korean patients with Rheumatic diseases
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.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study start1 Dec 2012
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kichul Shin, SMG-SNU Boramae Medical Center
- Investigators
- Eun Yeong Lee, MD, Principal investigator, Seoul National University HospitalTae-Hwan Kim, MD, Principal investigator, Hanyang UniversityShin-Seok Lee, MD, Principal investigator, Chonnam National University HospitalJaejoon Lee, MD, Principal investigator, SAMSUNG MEDICL CENTERChanghoon Lee, MD, Principal investigator, Wonkwang University HospitalChang-Keun Lee, MD, Principal investigator, Asan Medical CenterHyoun-Ah Kim, MD, Principal investigator, Ajou University School of MedicineSang-Il Lee, MD, Principal investigator, Gyeongsang National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965132
- Sponsor's protocol ID
- KOBIO_1
- Acronym
- KOBIO
- Status last verified
- Apr 2024
- First submitted
- 11 Oct 2013
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38479822Kim 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.
PubMed 35996930Kim 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.
PubMed 32696266Kim 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.
PubMed 31734899Kim 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.
PubMed 31365335