Surveillance of Humira in Korean JIA Patients

Polyarticular Juvenile Idiopathic Arthritis Clinical Trial

Official title:

Post-Marketing Surveillance of Humira Injection in Korean JIA Patients Under the New-Drug Re-examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02141984
• Other study ID #: P14-362
• Status: Completed
• Phase: N/A
• First received: May 16, 2014
• Last updated: May 4, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients who were diagnosed with polyarticular juvenile idiopathic arthritis(JIA) and were prescribed Humira by their physician according to the local label.

• Polyarticular juvenile idiopathic arthritis (JIA) patients for whom the response to previous disease-modifying anti rheumatic drug therapy has been inadequate

• 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:

• Patients with known hypersensitivity to Humira or any of its excipients.

• Patients who is participating on other clinical trials.

• Physician will refer to the product market authorization (label) for exclusion criteria.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Juvenile
• Polyarticular Juvenile Idiopathic Arthritis

Locations

Country	Name	City	State
Korea, Republic of	Site Reference ID/Investigator# 126665	Anyang-si
Korea, Republic of	Site Reference ID/Investigator# 126675	Chungju-si
Korea, Republic of	Site Reference ID/Investigator# 132941	Daegu
Korea, Republic of	Site Reference ID/Investigator# 126674	Daejeon
Korea, Republic of	Site Reference ID/Investigator# 126673	Jeonju-si
Korea, Republic of	Site Reference ID/Investigator# 126666	Seoul
Korea, Republic of	Site Reference ID/Investigator# 126667	Seoul
Korea, Republic of	Site Reference ID/Investigator# 132940	Seoul
Korea, Republic of	Site Reference ID/Investigator# 126668	Yangsan-si
Korea, Republic of	Site Reference ID/Investigator# 126670	Yangsan-si

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Adverse Events		Up to 70 days following the last scheduled administration of Humira Injection, an expected average of 3 months	Yes
Secondary	Changes in Active Joint Count	Active Joint Count will be assessed and collected by participated investigators in routine medical practice	From the first administration (Day 1) to approximately 12weeks (±4weeks)	No
Secondary	Physician's global assessment of the disease	Physician's global assessment of the disease will be measured.	At approximately 12 weeks (±4weeks)	No
Secondary	Parent's global assessment for effectiveness	Parent's global assessment for effectiveness will be measured.	At approximately 12 weeks (±4weeks)	No

External Links

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