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

Pfizer

Overview

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.

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

Study Type

OBSERVATIONAL

Conditions

Pediatric Psoriasis

Interventions

Enbrel groupDRUG

will be decided by treating physicians

Eligibility

Sex: ALLMin age: 8 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Safety measured by discontinuation due to adverse events

Time frame: 6 month

Secondary Outcomes

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

Time frame: 6 month

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

Time frame: 6 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.