Surveillance of Humira in Korean JIA Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Polyarticular Juvenile Idiopathic Arthritis

• Study Type: Observational
• Enrollment (Actual): 28

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

General hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with Polyarticular JIA or ERA; Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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.	Adverse Events (AEs) were collected from informed consent to within 70 days following the last scheduled administration of Humira (up to 22 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Active Joint Count From Baseline and 12 Weeks Post-Treatment	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.	From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Physician's Global Assessment of the Disease	The Physician's global assessment of the disease assessment was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'	From the first administration (Day 1) to approximately 12 weeks (±4 weeks)
Parent's Global Assessment for Effectiveness	Parent's global assessment for effectiveness was evaluated as 'Improved,' 'Not changed,' 'Aggravated,' or 'Not assessable.'	From the first administration (Day 1) to approximately 12 weeks (±4 weeks)

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 16, 2014
• First Posted (Estimate): May 20, 2014

Study Record Updates

• Last Update Posted (Actual): June 23, 2017
• Last Update Submitted That Met QC Criteria: April 7, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Korean regulatory required Postmarketing Surveillance
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: P14-362