Surveillance of Humira in Korean JIA Patients

NCT02141984 | Completed Results

• 1 other identifier: P14-362
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Polyarticular Juvenile Idiopathic Arthritis

Keywords

Korean regulatory required Postmarketing Surveillance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

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

• Physician's Global Assessment of the Disease

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

• Parent's Global Assessment for Effectiveness

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

Study Arms (1)

Patients with Polyarticular JIA or ERA

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

General hospital

You may qualify if:

• 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.

You may not qualify if:

• Patients with known hypersensitivity to Humira or any of its excipients.
• Patients who is participating on other clinical trials.

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• Eunjung Gu, MS

  AbbVie korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 20, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 23, 2017
• Results First Posted: June 23, 2017

Record last verified: 2017-04