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

Withdrawn

• Conditions: Pediatric Psoriasis
• Interventions: Drug: Enbrel group

• Registration Number: NCT01432249
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-12
• Study Start: 2013-03
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enbrel	Enbrel group	The patients who are prescribed Enbrel for pediatric psoriasis

Primary Outcome Measures

Name	Time	Method
Safety measured by discontinuation due to adverse events	6 month

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks	6 month
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	6 month