Surveillance of Humira in Korean JIA Patients

AbbVie

Status: Completed

Conditions: Polyarticular Juvenile Idiopathic Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02141984

P14-362

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

28 participants in 1 patient group

Patients with Polyarticular JIA or ERA

Description:

Patients with polyarticular juvenile idiopathic arthritis (JIA) or enthesitis-related arthritis (ERA)