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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01100034
First received: April 6, 2010
Last updated: July 7, 2015
Last verified: July 2015
  Purpose

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 Intervention
Psoriasis
Drug: Etanercept

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effectiveness or lack of effectiveness will be inferred from the number of 24 week courses the patient completes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
pediatric patients with plaque psoriasis on etanercept
Drug: Etanercept
Expected duration of 24 weeks as one course
Other Name: Enbrel

Detailed Description:

Non-probability sample

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

dermatology clinics

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 etanercept or other biologic agent
  • History of malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100034

Locations
France
Centre Hospitalier Victor Dupouy / Service de Dermatologie
Argenteuil Cedex, France, 95107
Hopital Trousseau, Service de Dermatologie
Chambray-lès-Tours, France, 37170
Hopital Saint Eloi
Montpellier, France, 34295
CHU de Nantes - Hôtel Dieu
Nantes, France, 44093
Service de Dermatologie
Quimper, France, 29107
Germany
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
Greece
University of Athens Andreas Syngros Hospital Athens, Greece
Athens, Greece, 16121
Hospital for Skin and Venereal Diseases
Thessaloniki, Greece, 54644
Papageorgiou General Peripheral Hospital of Thessaloniki
Thessaloniki, Greece, 56429
Hungary
Heim Pal Children's Hospital
Budapest, Hungary, 1089
Italy
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
Netherlands
UMC St Radbound
Nijmegen, Netherlands, 6500 HB
Erasmus MC
Rotterdam, Netherlands, 3000 CA
Portugal
Hospital Santa Maria
Lisboa, Portugal, 1649-028
Spain
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01100034     History of Changes
Other Study ID Numbers: 0881X1-4654, B1801035
Study First Received: April 6, 2010
Last Updated: July 7, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:
pediatric psoriasis
etanercept
PASS
safety
effectiveness

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015