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Korean College of Rheumatology Biologics and Targeted Therapy Registry

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01965132
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Seoul National University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eun Yeong Lee, MDTae-Hwan Kim, MDShin-Seok Lee, MDJaejoon Lee, MDChanghoon Lee, MDChang-Keun Lee, MDHyoun-Ah Kim, MDSang-Il Lee, MDJung-Yoon Choe, MDJae Hyun Jung, MDMi Ryoung Seo, MDJinseok Kim, MDMihye Kwon, MDJoo-Hyun Lee, MDSeong Wook Kang, MDKwi Young Kang, MDSung Won Lee, MDYoung-Beom Park, MDHyun-Sook Kim, MDDae Hyun Yu, MDSang-Heon Lee, MDYoung Mo Kang, MDKi Won Moon, MDSeung-Jae Hong, MDSang-Hyun Kim, MDGwan Gyu Song, MDJiwon Hwang, MDSung Hae Chang, MDJINHYUN KIM, MDJoo-Hyun Lee, MDWan Hee Ryu, MDIn-Ah Choi, MDHyun Ah Kim, MDKichul Shin, MD
Principal Investigator Affiliation Seoul National University HospitalHanyang UniversityChonnam National University HospitalSAMSUNG MEDICL CENTERWonkwang University HospitalAsan Medical CenterAjou University School of MedicineGyeongsang National University HospitalDaegu Catholic University Medical CenterKorea UniversityGachon University Gil Medical CenterJeju National University HospitalKONYANG UNIV. HOSPITALInje UniversityChungnam National University HospitalTHE CATHOLIC UNIV. OF KOREA INCHEON ST. MARY'S HOSPITALDong-A University HospitalSeverance HospitalSoonchunhyang University HospitalHanyang UniversityKonkuk University Medical CenterKyungpook National University HospitalKangWon National University HospitalKyunghee University Medical CenterKeimyung University Dongsan Medical CenterKorea University Guro HospitalSamsung Changwon HospitalSoonchunhyang University HospitalChungnam National University HospitalINJE UNIVERSITY ILSAN PAIK HOSPTIALChonbuk National University HospitalChungbuk National University HospitalHALLYM UNIVERSITY HOSPITALSMG-SNU Boramae Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Drug: - Biologic or targeted synthetic DMARD

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul Metropolitan Government-Seoul National University Boramae Medical Center

Seoul, , 07061

Site Contact

Kichul Shin, MD

kideb1@snu.ac.kr

+8228703204

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