Etanercept (Enbrel®) in Psoriasis - Pediatrics - Full Text View

Purpose

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

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

Condition	Intervention	Phase
Psoriasis	Drug: Enbrel® Drug: Placebo	Phase III

MedlinePlus related topics:

Children's Health Psoriasis

Drug Information available for:

Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Official Title:	Placebo-Controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

Further study details as provided by Amgen:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PASI 50 response at week 12 [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
PASI 90 response at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clear or almost clear status of sPGA (Static Physician Global Assessment of psoriasis) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent improvement from baseline in CDLQI (Children's Dermatology Life Quality Index) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
Pharmacokinetics [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment:	211
Study Start Date:	August 2004
Study Completion Date:	June 2007
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator 100 subjects - 12 weeks	Drug: Placebo 0.8 mg/kg (up to an intended dose of 50 mg) once weekly
Enbrel: Experimental 100 subjects	Drug: Enbrel® 0.8 mg/kg (up to an intended dose of 50 mg) once weekly

Eligibility

Ages Eligible for Study:	4 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078819

Sponsors and Collaborators

Amgen

Investigators


Study Director:	MD	Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Publications of Results:

Paller AS, Siegfried EC, Langley RG, Gottlieb AB, Pariser D, Landells I, Hebert AA, Eichenfield LF, Patel V, Creamer K, Jahreis A; Etanercept Pediatric Psoriasis Study Group. Etanercept treatment for children and adolescents with plaque psoriasis. N Engl J Med. 2008 Jan 17;358(3):241-51.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030211
First Received:	March 5, 2004
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00078819
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Pediatric Psoriasis

Study placed in the following topic categories:

Skin Diseases

Psoriasis

TNFR-Fc fusion protein

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Immunologic Factors

Physiological Effects of Drugs

Gastrointestinal Agents

Immunosuppressive Agents

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 21, 2008

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00078819