Surveillance of Humira in Korean JIA Patients
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polyarticular Juvenile Idiopathic Arthritis
Phase: N/A
Status: Recruiting
Sponsored by: AbbVie Official(s) and/or principal investigator(s): Eunjung Gu, MS, Study Director, Affiliation: AbbVie korea
Overall contact: Hyunjin Kim, Phone: +82 2 3429 9241, Email: hkim@abbvie.com
Summary
Approximately 600 pediatric patients prescribed Humira Injection in usual practice according
to the approved Korean product label will be registered into this observational study.
Baseline data will be obtained at enrollment including demographics, underlying diseases and
complications especially in regard to purified protein derivative (PPD) skin test, chest
X-ray. At routine visits for Humira Injection administration which will occur according to
usual medical practice, concomitant medication information and adverse events information
will be collected for up to 70 days after the last administration of Humira.
Clinical Details
Official title: Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Number of Subjects with Adverse Events
Secondary outcome: Changes in Active Joint CountPhysician's global assessment of the disease Parent's global assessment for effectiveness
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients who were diagnosed with polyarticular juvenile idiopathic arthritis(JIA) and
were prescribed Humira by their physician according to the local label.
2. Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to
previous disease-modifying anti rheumatic drug therapy has been inadequate
3. Patients who give written authorization form to use their personal and health data
from legal parents or representative.
Physician will refer to the product market authorization (label) for inclusion criteria.
Exclusion Criteria:
1. Patients with known hypersensitivity to Humira or any of its excipients.
2. Patients who is participating on other clinical trials. Physician will refer to the
product market authorization (label) for exclusion criteria.
Locations and Contacts
Hyunjin Kim, Phone: +82 2 3429 9241, Email: hkim@abbvie.com
Site Reference ID/Investigator# 126665, Anyang-si 431-070, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126665, Principal Investigator
Site Reference ID/Investigator# 126675, Chungju-si 361-711, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126675, Principal Investigator
Site Reference ID/Investigator# 132941, Daegu 700-712, Korea, Republic of; Recruiting Site Reference ID/Investigator# 132941, Principal Investigator
Site Reference ID/Investigator# 126672, Daejeon, Korea, Republic of; Not yet recruiting Site Reference ID/Investigator# 126672, Principal Investigator
Site Reference ID/Investigator# 126674, Daejeon 301-723, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126674, Principal Investigator
Site Reference ID/Investigator# 126671, Gwangju 501-717, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126671, Principal Investigator
Site Reference ID/Investigator# 126673, Jeonju-si 561-712, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126673, Principal Investigator
Site Reference ID/Investigator# 126666, Seoul, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126666, Principal Investigator
Site Reference ID/Investigator# 126667, Seoul 120-752, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126667, Principal Investigator
Site Reference ID/Investigator# 132940, Seoul 140-887, Korea, Republic of; Recruiting Site Reference ID/Investigator# 132940, Principal Investigator
Site Reference ID/Investigator# 126668, Yangsan-si 626-770, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126668, Principal Investigator
Site Reference ID/Investigator# 126670, Yangsan-si 626-770, Korea, Republic of; Recruiting Site Reference ID/Investigator# 126670, Principal Investigator
Additional Information
Starting date: May 2014
Last updated: July 13, 2015
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