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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Placebo-controlled Multicenter Study With Etanercept to Determine Safety and Efficacy in Pediatric Subjects With Plaque Psoriasis (PEDS)

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

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

Additional Information:

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

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

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.

Landells I, Paller AS, Pariser D, Kricorian G, Foehl J, Molta C, Freundlich B. Efficacy and safety of etanercept in children and adolescents aged > or = 8 years with severe plaque psoriasis. Eur J Dermatol. 2010 May-Jun;20(3):323-8. Epub 2010 Feb 25.

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00078819 History of Changes
Other Study ID Numbers:	20030211
Study First Received:	March 5, 2004
Last Updated:	December 22, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Pediatric Psoriasis

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 February 09, 2012