NCT01965132

Korean College of Rheumatology Biologics and Targeted Therapy Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	Biologic or targeted synthetic DMARD

Timeline

• Start date: 2012-12-01
• Primary completion: 2029-12-31
• Completion: 2030-06-30
• First posted: 2013-10-18
• Last updated: 2024-04-26

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study