This trial is active, not recruiting.

Condition pediatric plaque psoriasis
Treatment etanercept
Phase phase 3
Sponsor Amgen
Start date August 2005
End date December 2017
Trial size 182 participants
Trial identifier NCT00141921, 20050111


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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

Primary Outcomes

Subject incidence of adverse events, including infectious episodes, serious adverse events, and serious infectious episodes
time frame: 168 Weeks

Secondary Outcomes

Injection site reactions
time frame: 168 Weeks
exposure adjusted event rates for adverse events
time frame: 168 Weeks
infections and injection site reactions
time frame: 168 weeks
physical examination
time frame: 168 weeks
vital signs
time frame: 168 weeks
laboratory toxicities
time frame: 168 weeks
anti-etanercept antibodies
time frame: 168 weeks
time frame: 168 weeks
time frame: 168 weeks
time frame: 168 weeks
Clear or almost clear status of sPGA
time frame: 168 weeks
percent improvement in CDLQI
time frame: 168 Weeks
improvement from baseline in joint pain
time frame: 168 weeks
Percent improvement in PASI score
time frame: 168 weeks

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title An Open-Label Extension Study to Evaluate the Safety of Etanercept in Pediatric Subjects With Plaque Psoriasis
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Amgen.