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Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]

Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Juvenile Idiopathic Arthritis

Intervention: Etanercept (genetical recombination) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

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

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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: Improvement rating in DAS28

Secondary outcome: Overall improvement scale (assessed by physician)

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 ? 16 years

Exclusion Criteria:

- Patients not administered ENBREL

Locations and Contacts

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Yokohama City University School of, Tokyo, Japan; Recruiting
Syunpei Yokota
Additional Information

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

Starting date: July 2009
Last updated: October 31, 2011

Page last updated: December 08, 2011

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