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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)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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 polyarticular JIA. 1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious adverse events 2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.

Clinical Details

Official title: Enbrel-JIA Use Results Survey [All-Case Surveillance]

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome:

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.

Detailed description: All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis during registered period (2. 5 year).

Eligibility

Minimum age: 5 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Patients not administered ENBREL

Locations and Contacts

Yokohama City University School of, Tokyo, Japan
Additional Information

To obtain contact information for a study center near you, click here.

Starting date: July 2009
Last updated: August 20, 2014

Page last updated: August 20, 2015

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