Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis

Psoriasis Clinical Trial

— PURPOSE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100034
• Other study ID #: 0881X1-4654
• Secondary ID: B1801035
• Status: Completed
• Start date: November 19, 2010
• Est. completion date: September 24, 2018

Study information

• Verified date: October 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Non-probability sample

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 24, 2018
• Est. primary completion date: September 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept
Expected duration of 24 weeks as one course

Locations

Country	Name	City	State
France	Centre Hospitalier Victor Dupouy / Service de Dermatologie	Argenteuil Cedex
France	CHRU Tours Hopital Trousseau	Chambray-lès-Tours
France	CHU de Nantes - Hôtel Dieu	Nantes
France	CH Quimper Cornouaille	Quimper
Germany	Charite Universitaetsmedizin Berlin	Berlin
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	Universitaetsklinik Koeln	Köln
Germany	Kinderklinik der Johannes-Gutenberg Universitat Mainz	Mainz
Germany	Asklepios Klinik Sankt Augustin GmbH	Sankt Augustin
Greece	Andreas Syngros Hospital	Athens
Greece	University of Athens, Andreas Syngros Hospital	Athens
Greece	Skin and Venereal Diseases' Hospital	Thessaloniki
Hungary	Heim Pal Children's Hospital	Budapest
Italy	Universita degli Studi di Napoli	Napoli
Italy	Universita degli Studi di Napoli Federico II	Napoli
Italy	University of Padova	Padova
Italy	ARNAS Civico Di Gristina M Ascoli	Palermo
Italy	Università Cattolica del Sacro Cuore Policlinico A.	Roma
Italy	Ospitale Alfredo Fiorini	Terracina
Netherlands	UMC St Radbound	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Portugal	Hospital Santa Maria	Lisboa
Spain	Hospital de la Santa Cruz y San Pablo	Barcelona
Spain	Hospital Parc Tauli	Barcelona
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

France,  Germany,  Greece,  Hungary,  Italy,  Netherlands,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants	Serious infections were defined as any infections those were life-threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalisation. Opportunistic infections of interest included protocol-specified infections due to bacteria: Salmonella bacteremia, Campylobacteriosis, Shigellosis, Mycobacterium tuberculosis, Mycobacterium avium, Mycobacterium kansasii, Syphilis, Pseudomonas aeruginosa, Acinetobacter baumannii, Listeriosis, Nocardiosis, Legionellosis, Actinomycosis, Bartonellosis; Fungal: Aspergillosis, Invasive Candida albicans, Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Blastomycosis, Paracoccidioidomycosis, Sporotrichosis, Penicilliosis, Zygomycosis and Pneumocystosis; Protozoans: Cryptosporidiosis, Isosporiasis, Microsporidiosis, Acanthamoebiasis, Toxoplasmosis, Trypanosomiasis and Leishmaniasis; Viral: Cytomegalovirus, John Cunningham Virus, Disseminated or central nervous system herpes zoster, Kaposi's sarcoma and BK virus.	Baseline up to 5 years
Primary	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.	Baseline up to 28 days after last dose of study drug (up to 61 months)
Primary	Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants	Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.	Baseline up to 24 weeks
Primary	Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants	Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.	Week 24 up to Week 216
Primary	Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants	Participants those who completed the initial treatment period of at least 24 weeks and entered the follow up period, and during the follow up period who required subsequent treatment with etanercept or other systemic therapies were reported.	Week 24 up to Week 216
Secondary	Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period		Week 24 up to Week 216

External Links

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