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

An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00111436

Enrollment

912

Registered

2005-05-23

Start date

2003-04-30

Completion date

2005-07-31

Last updated

2013-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe, extension

Brief summary

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.

Interventions

DRUGEtanercept

Enbrel 50 mg once weekly or 50 mg twice weekly

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/

Exclusion criteria

of this protocol)

Design outcomes

Primary

Measure	Time frame
Subject incidence of adverse events, including infectious episodes	72 weeks
Changes from baseline in laboratory values	72 weeks

Secondary

Measure	Time frame
Patient Global Assessment of psoriasis	72 weeks
Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study	72 weeks
Changes from baseline in SF-36 Health Survey scores	72 weeks
Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores	72 weeks
Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis	72 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026