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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100034
Recruitment Status : Active, not recruiting
First Posted : April 8, 2010
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):

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 (8-17 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 4-17 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.

Condition or disease Intervention/treatment
Psoriasis Drug: Etanercept

Detailed Description:
Non-probability sample

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
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-authorization Safety Study (Pass)
Actual Study Start Date : November 2010
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept

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

Primary Outcome Measures :
  1. Number of SAEs including serious infections and malignancy [ Time Frame: Five year follow-up. Follow-up every 3 months for the first 2 years and 6 monthly for the next 3 yr ]

Secondary Outcome Measures :
  1. Effectiveness or lack of effectiveness will be inferred from the number of 24 week courses the patient completes [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
dermatology clinics

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 etanercept or other biologic agent
  • History of malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01100034

Centre Hospitalier Victor Dupouy / Service de Dermatologie
Argenteuil Cedex, France, 95107
Hopital Trousseau, Service de Dermatologie
Chambray-lès-Tours, France, 37170
CHU de Nantes - Hôtel Dieu
Nantes, France, 44093
Service de Dermatologie
Quimper, France, 29107
Klinik fuer Dermatologie, Allergologie und Venerologie
Berlin, Germany, 10117
Universitatsklinikum der TU Dresden Carl Gustav CarusKlinik
Dresden, Germany, 01307
Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052
Erlangen, Germany, 91052
Universitätsklinikum Hufelandstr. 55 Essen 45147
Essen, Germany, 45122
J W Goethe Universitaet Frankfurt
Frankfurt am Main, Germany, 60590
Kath. Kinderkrankenhaus Wilhelmstift
Hamburg, Germany, 22149
Universitaetsklinik Koeln
Köln, Germany, 50937
Kinderklinik der Johannes-Gutenberg Universitat Mainz
Mainz, Germany, 55101
Asklepios Klinik Sankt Augustin GmbH
Sankt Augustin, Germany, 53757
University of Athens Andreas Syngros Hospital Athens, Greece
Athens, Greece, 16121
Hospital for Skin and Venereal Diseases
Thessaloniki, Greece, 54644
Heim Pal Children's Hospital
Budapest, Hungary, 1089
Universita degli Studi di Napoli
Napoli, Italy, 80131
University of Padova
Padova, Italy, 35128
U.O. di Dermatologia ARNAS
Palermo, Italy, 90100
Cattedra Policlinico Gemelli
Roma, Italy, 00168
Ospedale Alfredo Fiorini
Terracina, Italy, 04019
UMC St Radbound
Nijmegen, Netherlands, 6500 HB
Erasmus MC
Rotterdam, Netherlands, 3000 CA
Hospital Santa Maria
Lisboa, Portugal, 1649-028
Hospital de la Santa Cruz y San Pablo
Barcelona, Spain, 08025
Hospital Parc Tauli
Barcelona, Spain, 08208
Hospital La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01100034     History of Changes
Other Study ID Numbers: 0881X1-4654
B1801035 ( Other Identifier: Alias Study Number )
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018

Keywords provided by Pfizer:
pediatric psoriasis

Additional relevant MeSH terms:
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors