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Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis

NCT ID: NCT00333034

Last Updated: 2007-12-06

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-05-31

Brief Summary

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The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

Detailed Description

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Conditions

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Psoriasis

Keywords

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Etanercept

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening.

Exclusion Criteria

-Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.\
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Austria, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Belguim, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For France, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Germany, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Hungary, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Italy, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Netherlands, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Poland, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Romania, [email protected]

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Spain, [email protected]

Locations

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Innsbruck, , Austria

Site Status

Brussels, , Belgium

Site Status

Leuven, , Belgium

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Bonn, , Germany

Site Status

Hamburg, , Germany

Site Status

München, , Germany

Site Status

Münster, , Germany

Site Status

Regensburg, , Germany

Site Status

Miskolc, , Hungary

Site Status

Szolnok, , Hungary

Site Status

Messina, , Italy

Site Status

Novara, , Italy

Site Status

Drachten, , Netherlands

Site Status

Nijmegen, , Netherlands

Site Status

Lodz, , Poland

Site Status

Wroclaw, , Poland

Site Status

Bucharest, , Romania

Site Status

Cluj-Napoca, , Romania

Site Status

A Coruña, , Spain

Site Status

Madrid, , Spain

Site Status

Seville, , Spain

Site Status

Countries

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Austria Belgium France Germany Hungary Italy Netherlands Poland Romania Spain

References

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Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17. No abstract available.

Reference Type DERIVED
PMID: 25913550 (View on PubMed)

Other Identifiers

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0881A6-318

Identifier Type: -

Identifier Source: org_study_id