Korean College of Rheumatology Biologics and Targeted Therapy Registry

Rheumatoid Arthritis Clinical Trial

— KOBIO  

Official title:

Korean College of Rheumatology Biologics and Targeted Therapy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01965132
• Other study ID #: KOBIO_1
• Status: Recruiting
• Start date: December 1, 2012
• Est. completion date: June 30, 2030

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Kichul Shin, MD
• Email: kideb1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. As this registry is to observe the "real world" use of anti-rheumatic treatments under routine clinical practice, no hypothesis to prove is planned.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: June 30, 2030
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Biologic or targeted synthetic DMARD

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government-Seoul National University Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 10 years