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

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)

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Etanercept

Detailed Description

Non-probability sample

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• France
  • Argenteuil Cedex, France, 95107
    • Centre Hospitalier Victor Dupouy / Service de Dermatologie
  • Chambray-lès-Tours, France, 37170
    • CHRU Tours Hôpital Trousseau
  • Nantes, France, 44093
    • CHU de Nantes - Hotel Dieu
  • Quimper, France, 29000
    • CH Quimper Cornouaille
• Germany
  • Berlin, Germany, 10117
    • Charite Universitaetsmedizin Berlin
  • Dresden, Germany, 01307
    • Universitaetsklinik Carl Gustav Carus
  • Erlangen, Germany, 91052
    • Hautklinik Universitaetsklinikum Erlangen
  • Essen, Germany, 45122
    • Universitatsklinikum Essen
  • Frankfurt am Main, Germany, 60590
    • J W Goethe Universitaet Frankfurt
  • Hamburg, Germany, 53757
    • Kath. Kinderkrankenhaus Wilhelmstift
  • Köln, Germany, 50937
    • Universitaetsklinik Koeln
  • Mainz, Germany, 55101
    • Kinderklinik der Johannes-Gutenberg Universitat Mainz
  • Sankt Augustin, Germany, 53757
    • Asklepios Klinik Sankt Augustin GmbH
• Greece
  • Athens, Greece, 16121
    • Andreas Syngros Hospital
  • Athens, Greece, 16121
    • University of Athens, Andreas Syngros Hospital
  • Thessaloniki, Greece, 54643
    • Skin and Venereal Diseases' Hospital
• Hungary
  • Budapest, Hungary, 1089
    • Heim Pal Children's Hospital
• Italy
  • Napoli, Italy, 80131
    • Università degli Studi di Napoli Federico II
  • Napoli, Italy, 80131
    • Universita degli Studi di Napoli
  • Padova, Italy, 35128
    • University of Padova
  • Palermo, Italy, 90127
    • ARNAS Civico Di Gristina M Ascoli
  • Roma, Italy, 00168
    • Università Cattolica del Sacro Cuore Policlinico A.
  • Terracina, Italy, 04019
    • Ospitale Alfredo Fiorini
• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • UMC St Radbound
  • Rotterdam, Netherlands, 3000 CA
    • Erasmus MC
• Portugal
  • Lisboa, Portugal, 1649-028
    • Hospital Santa Maria
• Spain
  • Barcelona, Spain, 08208
    • Hospital Parc Tauli
  • Barcelona, Spain, 08025
    • Hospital de la Santa Cruz y San Pablo
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

dermatology clinics

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; pediatric patients with plaque psoriasis on etanercept	Drug: Etanercept; Expected duration of 24 weeks as one course; Other Names: Enbrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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
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 Outcome Measures

Outcome Measure	Time Frame
Duration of Subsequent Etanercept Treatment After Completion of Initial Treatment Period	Week 24 up to Week 216

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2010
• Primary Completion (Actual): September 24, 2018
• Study Completion (Actual): September 24, 2018

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: safety; effectiveness; PASS; etanercept; pediatric psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 0881X1-4654; B1801035 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.