Pediatric Open-Label Extension Study - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00141921

Purpose

The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in pediatric subjects with moderate to severe psoriasis.

Condition	Intervention	Phase
Pediatric Plaque Psoriasis	Drug: Etanercept	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis

Further study details as provided by Amgen:

Primary Outcome Measures:

Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Injection site reactions [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
exposure adjusted event rates for adverse events [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
infections and injection site reactions [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
physical examination [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
vital signs [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
laboratory toxicities [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
anti-etanercept antibodies [ Time Frame: 168 Weeks ] [ Designated as safety issue: Yes ]
PASI 50 [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
PASI 75 [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
PASI 90 [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
Clear or almost clear status of sPGA [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
percent improvement in CDLQI [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
improvement from baseline in joint pain [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]
Percent improvement in PASI score [ Time Frame: 168 Weeks ] [ Designated as safety issue: No ]

Enrollment:	182
Study Start Date:	August 2005
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Etanercept open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given QW SC in 1 or 2 injections

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: - Enrollment on previous Amgen study 20030211 Exclusion Criteria: - Serious or clinically significant adverse event on Amgen study 20030211 related to etanercept

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141921

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050111
Study First Received:	August 31, 2005
Last Updated:	February 20, 2008
ClinicalTrials.gov Identifier:	NCT00141921
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Pediatric,
plaque psoriasis
clinical trial
Immunex
Amgen

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 January 13, 2009