Korean College of Rheumatology Biologics and Targeted Therapy Registry (KOBIO)

Seoul National University

Status: Enrolling

Conditions: Psoriatic Arthritis; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Drug: Biologic or targeted synthetic DMARD

Study type: Observational

Funder types: Other

Identifiers

NCT01965132

KOBIO_1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

10,000 participants in 1 patient group

Biologic or targeted synthetic DMARD

Description:

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

Treatment:

Drug: Biologic or targeted synthetic DMARD