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

• Status: Withdrawn
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Etanercept

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)