Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab

NCT ID: NCT01543204

Last Updated: 2017-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2015-05-29

Brief Summary

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This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.

Detailed Description

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Conditions

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Psoriasis

Keywords

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plaque psoriasis etanercept adalimumab

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Etanercept 50 mg

Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.

Group Type EXPERIMENTAL

Etanercept

Intervention Type DRUG

Administered by subcutaneous injection

Interventions

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Etanercept

Administered by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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EnbrelĀ®

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe plaque psoriasis
* Loss of satisfactory response to adalimumab
* Currently receiving or recently discontinued treatment with adalimumab

Exclusion Criteria

* Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
* Serious medical conditions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Bakersfield, California, United States

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Encino, California, United States

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Irvine, California, United States

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Los Angeles, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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San Ramon, California, United States

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Santa Monica, California, United States

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Denver, Colorado, United States

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Farmington, Connecticut, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Macon, Georgia, United States

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Skokie, Illinois, United States

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New Albany, Indiana, United States

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Plainfield, Indiana, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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East Windsor, New Jersey, United States

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Verona, New Jersey, United States

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Rochester, New York, United States

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Pittsburgh, Pennsylvania, United States

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Plymouth Meeting, Pennsylvania, United States

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Johnston, Rhode Island, United States

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Charleston, South Carolina, United States

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Bartlett, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Norfolk, Virginia, United States

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Walla Walla, Washington, United States

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Markham, Ontario, Canada

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Peterborough, Ontario, Canada

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Waterloo, Ontario, Canada

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Countries

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United States Canada

References

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Bagel J, Tyring S, Rice KC, Collier DH, Kricorian G, Chung J, Iles J, Stolshek BS, Kaliyaperumal A, Papp KA. Open-label study of etanercept treatment in patients with moderate-to-severe plaque psoriasis who lost a satisfactory response to adalimumab. Br J Dermatol. 2017 Aug;177(2):411-418. doi: 10.1111/bjd.15381. Epub 2017 Jul 19.

Reference Type BACKGROUND
PMID: 28196270 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101145

Identifier Type: -

Identifier Source: org_study_id