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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 Count

Physician'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

Page last updated: August 23, 2015

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