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Clinical Trials in South Korea / NCT01965132
Recruiting Observational

Korean College of Rheumatology Biologics and Targeted Therapy Registry

NCT01965132 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Observational
Started
2012-12-01
Last updated
2024-04-26

Condition(s) studied

Rheumatoid ArthritisAnkylosing SpondylitisPsoriatic Arthritis

Investigational drug(s) / intervention(s)

Biologic or targeted synthetic DMARD →

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Seoul Metropolitan Government-Seoul National University Boramae Medical Center Seoul South Korea Recruiting

More Seoul National University Hospital trials in South Korea

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Other trials for the same condition

Multi-omics Database for Integrative Microbiome Analysis in a Cohort of Korean Patients With Ankylosing Spondylitis Recruiting
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting
G7 Dual Mobility With Vivacit-E or Longevity PMCF Enrolling by invitation
A Study to Evaluate Different Targeted Therapies for Patients With Rheumatoid Arthritis Recruiting
A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01965132 on ClinicalTrials.gov ↗ ← All trials in South Korea