Study Evaluating the Safety and Effectiveness of Etanercept for the Treatment of Pediatric Psoriasis
- Registration Number
- NCT01100034
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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
- Prior therapy with any biologic agent other than etanercept
- History of malignancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 Etanercept pediatric patients with plaque psoriasis on etanercept
- Primary Outcome Measures
Name Time Method Number of Participants Who Discontinued From Etanercept After Initial Treatment Period: Prospective Participants Week 24 up to Week 216 Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
Percentage of Participants Who Required Subsequent Treatment With Etanercept or Other Systemic Therapies After Completion of Initial Treatment Period: Prospective Participants Week 24 up to Week 216 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.
Number of Participants With Serious Infections, Opportunistic Infections of Interest and Malignancies: Prospective Participants Baseline up to 5 years 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.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Prospective Participants Baseline up to 28 days after last dose of study drug (up to 61 months) 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.
Number of Participants Who Discontinued From Etanercept During Initial Treatment Period: Prospective Participants Baseline up to 24 weeks Initial treatment period is defined as the period during which participants received Etanercept treatment for a duration of at least 24 weeks.
- Secondary Outcome Measures
Name Time Method Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period Week 24 up to Week 216
Trial Locations
- Locations (29)
Heim Pal Children's Hospital
🇭🇺Budapest, Hungary
Skin and Venereal Diseases' Hospital
🇬🇷Thessaloniki, Greece
University of Athens, Andreas Syngros Hospital
🇬🇷Athens, Greece
Erasmus MC
🇳🇱Rotterdam, Netherlands
Hospital Santa Maria
🇵🇹Lisboa, Portugal
CHRU Tours Hopital Trousseau
🇫🇷Chambray-lès-Tours, France
CHU de Nantes - Hôtel Dieu
🇫🇷Nantes, France
Centre Hospitalier Victor Dupouy / Service de Dermatologie
🇫🇷Argenteuil Cedex, France
CH Quimper Cornouaille
🇫🇷Quimper, France
Hautklinik Universitaetsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitaetsklinik Koeln
🇩🇪Köln, Germany
Charite Universitaetsmedizin Berlin
🇩🇪Berlin, Germany
Kath. Kinderkrankenhaus Wilhelmstift
🇩🇪Hamburg, Germany
Universitätsklinikum Essen
🇩🇪Essen, Germany
J W Goethe Universitaet Frankfurt
🇩🇪Frankfurt am Main, Germany
Andreas Syngros Hospital
🇬🇷Athens, Greece
UMC St Radbound
🇳🇱Nijmegen, Netherlands
Universita degli Studi di Napoli Federico II
🇮🇹Napoli, Italy
University of Padova
🇮🇹Padova, Italy
Università Cattolica del Sacro Cuore Policlinico A.
🇮🇹Roma, Italy
Ospitale Alfredo Fiorini
🇮🇹Terracina, Italy
Hospital Parc Tauli
🇪🇸Barcelona, Spain
Hospital de la Santa Cruz y San Pablo
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Universita degli Studi di Napoli
🇮🇹Napoli, Italy
ARNAS Civico Di Gristina M Ascoli
🇮🇹Palermo, Italy
Kinderklinik der Johannes-Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
Asklepios Klinik Sankt Augustin GmbH
🇩🇪Sankt Augustin, Germany
Universitaetsklinik Carl Gustav Carus
🇩🇪Dresden, Germany