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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

Page last updated: February 07, 2013

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