Surveillance of Humira in Korean JIA Patients

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, and 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.

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Key information

Conditions

Polyarticular Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients from 2 years of age who were diagnosed with polyarticular juvenile idiopathic arthritis (JIA) or patients from 6 years of age who were diagnosed with enthesitis-related arthritis (ERA).
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.

Treatment and study plan

Primary outcomes

Number of Participants With Adverse Events

Time frame: Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either related, possible, probably not, not related, or unassessable. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.

Secondary outcomes

Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment

Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

Active Joint Count will be assessed and collected by participating investigators in routine medical practice. Sixty-eight joints were assessed by physical examination. Active joints are defined as joints with positive results for tenderness, swelling, pain on passive motion, or limitation of passive motion. Higher scores represent higher disease activity.
Physician's Global Assessment of the Disease

Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'
Parent's Global Assessment for Effectiveness

Time frame: From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: May 20, 2014
Registry last updated: Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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