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

NCT01100034 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2019-10-08

Study results available
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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.

Conditions

Interventions

DRUG

Etanercept

Expected duration of 24 weeks as one course

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-19
Primary Completion
2018-09-24
Completion
2018-09-24

Countries

  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01100034 on ClinicalTrials.gov