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Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

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Amgen

Status and phase

Completed
Phase 3

Conditions

Psoriasis

Treatments

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00111449
20030117

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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