Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Etanercept (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Amgen Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen
Summary
The purpose of this study is to determine the effect of etanercept 50 mg twice weekly
compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects
with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg
twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported
outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice
weekly.
Clinical Details
Official title: A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
Secondary outcome: Dermatology Live Quality Index (DLQI) response at week 12Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12 Psoriasis pain (VAS) at week 12 Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12 PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy Adverse events, infections injection site reactions during long-term therapy Serious adverse events and infections during long-term therapy Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of
the screening visit (e. g., eczema) that would interfere with evaluations of the effect of
an investigational product on psoriasis
Locations and Contacts
Additional Information
ClinicalStudyResults website - Results posting for study 20030117 AmgenTrials clinical trials website Notice regarding posted summaries of trial results To access clinical trial results information click on this link FDA-approved Drug Labeling
Starting date: June 2003
Last updated: May 15, 2008
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