Etanercept (Enbrel®) in Psoriasis - Pediatrics

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT00078819

First received: March 5, 2004

Last updated: July 26, 2013

Last verified: July 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2004

Last Updated Date

July 26, 2013

Start Date ^ICMJE

August 2004

Primary Completion Date

February 2006 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PASI (Psoriasis Area and Severity Index) 75 response at week 12, defined as a 75% or greater decrease in PASI score (i.e., improvement) from baseline at week 12. [ Time Frame: 12 weeks ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00078819 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PASI 50 response at week 12 [ Time Frame: 12 Weeks ]
PASI 90 response at week 12 [ Time Frame: 12 weeks ]
Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 [ Time Frame: 12 weeks ]
Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 [ Time Frame: 12 weeks ]
Safety as measured by adverse events, infections, injection site reaction, lab toxicity, vital signs, antibodies to etanercept, and disease rebound during the investigational product withdrawal period [ Time Frame: 48 weeks ]
Pharmacokinetics [ Time Frame: 48 weeks ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Etanercept (Enbrel®) in Psoriasis - Pediatrics

Official Title ^ICMJE

Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

Brief Summary

This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.

This is a Phase 3 blinded, placebo-controlled study.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Enbrel®
0.8 mg/kg (up to an intended dose of 50 mg) once weekly
Drug: Placebo
0.8 mg/kg (up to an intended dose of 50 mg) once weekly

Study Arms

Placebo Comparator: Placebo
100 subjects - 12 weeks

Intervention: Drug: Placebo
Experimental: Enbrel
100 subjects

Intervention: Drug: Enbrel®

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

211

Completion Date

June 2007

Primary Completion Date

February 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Patients with plaque psoriasis - Patient may not receive certain psoriasis medications during the study

Sex/Gender

Sexes Eligible for Study:

All

Ages

4 Years to 17 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Canada, United States

Administrative Information

NCT Number ^ICMJE

NCT00078819

Other Study ID Numbers ^ICMJE

20030211

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Amgen

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

PRS Account

Amgen

Verification Date

July 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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