Korean College of Rheumatology Biologics and Targeted Therapy Registry

Recruiting

• Conditions: Psoriatic Arthritis; Rheumatoid Arthritis; Ankylosing Spondylitis
• Interventions: Drug: Biologic or targeted synthetic DMARD

• Registration Number: NCT01965132
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2012-12-01
• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-15
• Study First Posted: 2013-10-18
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-26
• Primary Completion: 2029-12-31
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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).

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Exclusion Criteria

• RA, AS, PsA patients who are already on biologics or targeted synthetic DMARDs upon screening

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biologic or targeted synthetic DMARD	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

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events during the use of biologics or targeted synthetic DMARDs in Korean patients with Rheumatic diseases	up to 10 years	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.

Trial Locations

Locations (1)

Seoul Metropolitan Government-Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of