Clinical trial NCT01100034: Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
Official title: A LONG-TERM, PROSPECTIVE, OBSERVATIONAL COHORT STUDY OF THE SAFETY AND EFFECTIVENESS OF ETANERCEPT IN THE TREATMENT OF PAEDIATRIC PSORIASIS PATIENTS IN A NATURALISTIC SETTING: A POST-AUTHORISATION SAFETY STUDY (PASS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: pediatric psoriasis
etanercept
PASS
safety
effectiveness
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: dermatology clinics

Brief 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.

Detailed description: Non-probability sample

Eligibility 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 any biologic agent other than etanercept
* History of malignancy

Primary outcomes:
measure: Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants
timeFrame: Baseline up to 5 years
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants
timeFrame: Baseline up to 28 days after last dose of study drug (up to 61 months)
measure: Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants
timeFrame: Baseline up to 24 weeks
measure: Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants
timeFrame: Week 24 up to Week 216
measure: Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants
timeFrame: Week 24 up to Week 216
Secondary outcomes:
measure: Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period
timeFrame: Week 24 up to Week 216
Other outcomes:
Locations:
city: Argenteuil Cedex
country: France
facility: Centre Hospitalier Victor Dupouy / Service de Dermatologie
city: Chambray-lès-Tours
country: France
facility: CHRU Tours Hopital Trousseau
city: Nantes
country: France
facility: CHU de Nantes - Hôtel Dieu
city: Quimper
country: France
facility: CH Quimper Cornouaille
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Dresden
country: Germany
facility: Universitaetsklinik Carl Gustav Carus
city: Erlangen
country: Germany
facility: Hautklinik Universitaetsklinikum Erlangen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Frankfurt am Main
country: Germany
facility: J W Goethe Universitaet Frankfurt
city: Hamburg
country: Germany
facility: Kath. Kinderkrankenhaus Wilhelmstift
city: Köln
country: Germany
facility: Universitaetsklinik Koeln
city: Mainz
country: Germany
facility: Kinderklinik der Johannes-Gutenberg Universitat Mainz
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin GmbH
city: Athens
country: Greece
facility: Andreas Syngros Hospital
city: Athens
country: Greece
facility: University of Athens, Andreas Syngros Hospital
city: Thessaloniki
country: Greece
facility: Skin and Venereal Diseases' Hospital
city: Budapest
country: Hungary
facility: Heim Pal Children's Hospital
city: Napoli
country: Italy
facility: Universita degli Studi di Napoli Federico II
city: Napoli
country: Italy
facility: Universita degli Studi di Napoli
city: Padova
country: Italy
facility: University of Padova
city: Palermo
country: Italy
facility: ARNAS Civico Di Gristina M Ascoli
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore Policlinico A.
city: Terracina
country: Italy
facility: Ospitale Alfredo Fiorini
city: Nijmegen
country: Netherlands
facility: UMC St Radbound
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
city: Barcelona
country: Spain
facility: Hospital de la Santa Cruz y San Pablo
city: Barcelona
country: Spain
facility: Hospital Parc Tauli
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: