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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01100034
First received: April 6, 2010
Last updated: August 12, 2014
Last verified: September 2012
  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 Phase
Psoriasis
Drug: Etanercept
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term, Prospective, Observational Cohort Study of Safety and Effectiveness of Pediatric Psoriasis Patients Treated With Etanercept 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: 200
Study Start Date: November 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 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:   4 Years 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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Austria
University Hospital Graz Recruiting
Graz, Austria, 8036
France
Service de Dermatologie Recruiting
Quimper, France, 29107
Germany
Klinik fuer Dermatologie, Allergologie und Venerologie Recruiting
Berlin, Germany, 10117
Universitatsklinikum der TU Dresden Carl Gustav CarusKlinik Recruiting
Dresden, Germany, 01307
Universitätsklinikum Hartmmannstrasse 14 Erlangen 91052 Recruiting
Erlangen, Germany, 91052
Universitätsklinikum Hufelandstr. 55 Essen 45147 Recruiting
Essen, Germany, 45122
J W Goethe Universitaet Frankfurt Recruiting
Frankfurt am Main, Germany, 60590
Kath. Kinderkrankenhaus Wilhelmstift Recruiting
Hamburg, Germany, 22149
Friedrich-Schiller Universitat Jena Recruiting
Jena, Germany, 07740
Universitaetsklinik Koeln Recruiting
Köln, Germany, 50937
Kinderklinik der Johannes-Gutenberg Universitat Mainz Recruiting
Mainz, Germany, 55101
Asklepios Klinik Sankt Augustin GmbH Recruiting
Sankt Augustin, Germany, 53757
Italy
Universita degli Studi di Napoli Recruiting
Napoli, Italy, 80131
U.O. di Dermatologia ARNAS Not yet recruiting
Palermo, Italy, 90100
Cattedra Policlinico Gemelli Recruiting
Roma, Italy, 00168
Ospedale Alfredo Fiorini Recruiting
Terracina, Italy, 04019
Netherlands
UMC St Radbound Recruiting
Nijmegen, Netherlands, 6500 HB
Erasmus MC Recruiting
Rotterdam, Netherlands, 3000 CA
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
Study First Received: April 6, 2010
Last Updated: August 12, 2014
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, Papulosquamous
Skin Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014