Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

912 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-07-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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50 mg

50 mg once weekly

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Enbrel 50 mg once weekly or 50 mg twice weekly

100 mg

50 mg twice weekly

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Enbrel 50 mg once weekly or 50 mg twice weekly

Interventions

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Etanercept

Enbrel 50 mg once weekly or 50 mg twice weekly

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Pregnant or breast-feeding females
* Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No