Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Status:
Completed
Trial end date:
2018-09-24
Target enrollment:
Participant gender:
Summary
Psoriasis is a chronic, often severe, autoimmune condition that affects approximately 2% of
the world's population. The epidemiology of pediatric psoriasis has not been well documented
and no treatment guidelines exist for pediatric psoriasis.
Etanercept is a biologic drug and has been licensed for the treatment of chronic severe
plaque psoriasis in children and adolescents (6-17 years of age) who are inadequately
controlled by or are intolerant to, other systemic therapies or phototherapies. Although the
long-term safety and efficacy of etanercept in children with juvenile idiopathic arthritis
(JIA) has been studied and the short-term safety profile of etanercept in both JIA and
pediatric psoriasis appears similar, there is limited data available about the long-term
effects of etanercept in pediatric psoriasis, especially with respect to malignancy. The aim
of this study is to assess the safety and effectiveness of etanercept for the treatment of
pediatric psoriasis in Europe. Patients aged <=17 with plaque psoriasis diagnosed by a
dermatologist will be invited to participate in the registry only after a clinical decision
has been made to prescribe etanercept. The safety of the drug and how well the drug works
will be evaluated during the follow-up period. The follow-up period will last 5 years and
patients will be followed up every 3 months for the first 2 years and every 6 months for the
next 3 years or until the end of study.