Observational Safety Study of Enbrel for Treatment of Psoriasis
This is an observational safety study tracking psoriasis subjects on Enbrel for 5 years.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis|
- Assess long-term safety of participating subjects, determine incidence rates of Serious Adverse Events (SAEs) and Serious Infectious Events (SIEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Patient- and physician- reported outcomes and healthcare resource use over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Whether rates of SAEs, SIEs, and EMIs differ according to (a) prior exposure to systemic therapies or phototherapy, (b) exposure to Enbrel therapy, and (c) presence of certain co-morbid disorders [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Evaluate incidence rates of Events of Medical Interests (EMIs) for participating subjects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Whole blood, serum, plasma.
|Study Start Date:||May 2006|
|Study Completion Date:||February 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
The trial is an observational study to gather and evaluate data on long-term safety of Entanercept use in the treatment of psoriasis. Subjects with plaque psoriasis who were receiving Etanercept or who were intending to start or restart Etanercept therapy were eligible to be enrolled into the study.
Subjects will receive at least one dose of prescribed etanercept as per prescribing information for the treatment of plaque psoriasisDrug: Enbrel
Subjects will receive at least one dose of prescribed Enbrel (etanercept) as per prescribing information for the treatment of plaque psoriasis
This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of Enbrel use in the treatment of psoriasis.