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Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediatric Psoriasis

Intervention: Enbrel group (Drug)

Phase: Phase 4

Status: Not yet 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

Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.

Clinical Details

Official title: Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Safety measured by discontinuation due to adverse events

Secondary outcome:

Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks

Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks

Detailed description: All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.

Eligibility

Minimum age: 8 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Children and adolescents aged 8 years to 17 years at time of consent

2. Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies

Exclusion Criteria:

1. Patients with known hypersensitivity to Enbrel or any component of the product

2. Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)

Locations and Contacts

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

Additional Information

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

Starting date: November 2012
Last updated: January 16, 2013

Page last updated: February 07, 2013

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