Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Etanercept (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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 (8-17 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 4-17 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.
Clinical Details
Official title: Long-Term, Prospective, Observational Cohort Study of Safety and Effectiveness of Pediatric Psoriasis Patients Treated With Etanercept in a Naturalistic Setting: A Post-Authorization Safety Study (PASS)
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Number of SAEs including serious infections and malignancy
Secondary outcome: Effectiveness or lack of effectiveness will be inferred from the number of 24 week courses the patient completes
Detailed description:
Non-probability sample
Eligibility
Minimum age: 4 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 17 years of age or younger
- Diagnosed with plaque psoriasis by a dermatologist.
- Prior to enrollment, there must be a clinical decision to initiate etanercept for the
treatment of plaque psoriasis and etanercept must then be initiated.
- Actively being treated with etanercept, regardless of length of treatment prior to
enrollment
- Willing to provide written informed consent
Exclusion Criteria:
- Prior therapy with etanercept or other biologic agent
- History of malignancy
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
University Hospital Graz, Graz 8036, Austria; Recruiting
Service de Dermatologie, Quimper 29107, France; Recruiting
Klinik fuer Dermatologie, Allergologie und Venerologie, Berlin 10117, Germany; Recruiting
Universitatsklinikum der TU Dresden Carl Gustav CarusKlinik, Dresden 01307, Germany; Recruiting
Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052, Erlangen 91052, Germany; Recruiting
Universitätsklinikum Hufelandstr. 55 Essen 45147, Essen 45122, Germany; Recruiting
J W Goethe Universitaet Frankfurt, Frankfurt am Main 60590, Germany; Recruiting
Kath. Kinderkrankenhaus Wilhelmstift, Hamburg 22149, Germany; Recruiting
Friedrich-Schiller Universitat Jena, Jena 07740, Germany; Recruiting
Universitaetsklinik Koeln, Köln 50937, Germany; Recruiting
Kinderklinik der Johannes-Gutenberg Universitat Mainz, Mainz 55101, Germany; Recruiting
Asklepios Klinik Sankt Augustin GmbH, Sankt Augustin 53757, Germany; Recruiting
University of Athens Andreas Syngros Hospital Athens, Greece, Athens 16121, Greece; Not yet recruiting
Universita degli Studi di Napoli, Napoli 80131, Italy; Recruiting
U.O. di Dermatologia ARNAS, Palermo 90100, Italy; Recruiting
Cattedra Policlinico Gemelli, Roma 00168, Italy; Recruiting
Ospedale Alfredo Fiorini, Terracina 04019, Italy; Recruiting
UMC St Radbound, Nijmegen 6500 HB, Netherlands; Recruiting
Erasmus MC, Rotterdam 3000 CA, Netherlands; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2010
Last updated: January 16, 2013
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