Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis|
- Safety measured by discontinuation due to adverse events [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
The patients who are prescribed Enbrel for pediatric psoriasis
Drug: Enbrel group
will be decided by treating physicians
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.