Pediatric Psoriasis
Conditions
Keywords
pediatric psoriasis, enbrel, safety, efficacy
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.
Interventions
DRUGEnbrel group
will be decided by treating physicians
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured by discontinuation due to adverse events | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Outcome results
None listed