Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatric Psoriasis
Intervention: Enbrel group (Drug)
Phase: Phase 4
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
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
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
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as
per the local product information for usage.
Minimum age: 8 Years.
Maximum age: 17 Years.
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
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
To obtain contact information for a study center near you, click here.
Starting date: March 2013
Last updated: November 14, 2013