Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Juvenile Idiopathic Arthritis
Intervention: Etanercept (genetical recombination) (Drug)
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
This surveillance is conducted to survey the followings under the post marketed drug
utilization on the patients who are administrated ENBREL as a treatment for active
1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious
2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.
Official title: Enbrel-JIA Use Results Survey [All-Case Surveillance]
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Number of Participants With Treatment-Related Adverse Events of Etanercept
Number of Participants With Serious Treatment-Related Adverse Events of Etanercept
Number of Unlisted Treatment-Related Adverse Events of Etanercept
Percentage of Good Responders and Moderate Responders Among Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Secondary outcome: Percentage of Participants With Overall Improvement On Physician's Assessment.
All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis
during registered period (2. 5 year).
Minimum age: 5 Years.
Maximum age: 16 Years.
- Patients in active polyarticular JIA (restricted to the case of lack of effect by
other treatment) during enrollment period (2. 5years).
- Patients receiving Enbrel for JIA as diagnosed by a qualified physician.
- Age 5 - 16 years
- Patients not administered ENBREL
Locations and Contacts
Yokohama City University School of, Tokyo, Japan
To obtain contact information for a study center near you, click here.
Starting date: July 2009
Last updated: August 20, 2014