Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
NCT ID: NCT01100034
Last Updated: 2019-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
72 participants
OBSERVATIONAL
2010-11-19
2018-09-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
pediatric patients with plaque psoriasis on etanercept
Etanercept
Expected duration of 24 weeks as one course
Interventions
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Etanercept
Expected duration of 24 weeks as one course
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* History of malignancy
6 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Centre Hospitalier Victor Dupouy / Service de Dermatologie
Argenteuil, , France
CHRU Tours Hopital Trousseau
Chambray-lès-Tours, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
CH Quimper Cornouaille
Quimper, , France
Charite Universitaetsmedizin Berlin
Berlin, , Germany
Universitaetsklinik Koeln
Cologne, , Germany
Universitaetsklinik Carl Gustav Carus
Dresden, , Germany
Hautklinik Universitaetsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
J W Goethe Universitaet Frankfurt
Frankfurt am Main, , Germany
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, , Germany
Kinderklinik der Johannes-Gutenberg Universitat Mainz
Mainz, , Germany
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, , Germany
Andreas Syngros Hospital
Athens, , Greece
University of Athens, Andreas Syngros Hospital
Athens, , Greece
Skin and Venereal Diseases' Hospital
Thessaloniki, , Greece
Heim Pal Children's Hospital
Budapest, , Hungary
Universita degli Studi di Napoli Federico II
Napoli, , Italy
Universita degli Studi di Napoli
Napoli, , Italy
University of Padova
Padua, , Italy
ARNAS Civico Di Gristina M Ascoli
Palermo, , Italy
Università Cattolica del Sacro Cuore Policlinico A.
Roma, , Italy
Ospitale Alfredo Fiorini
Terracina, , Italy
UMC St Radbound
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Hospital Santa Maria
Lisbon, , Portugal
Hospital de la Santa Cruz y San Pablo
Barcelona, , Spain
Hospital Parc Tauli
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1801035
Identifier Type: OTHER
Identifier Source: secondary_id
0881X1-4654
Identifier Type: -
Identifier Source: org_study_id
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