Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis - Full Text View

Sponsors and Collaborators:	Amgen Wyeth
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00111449

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Etanercept	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

Further study details as provided by Amgen:

Primary Outcome Measures:

Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Secondary Outcome Measures:

Dermatology Live Quality Index (DLQI) response at week 12
Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Psoriasis pain (VAS) at week 12
Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Adverse events, infections injection site reactions during long-term therapy
Serious adverse events and infections during long-term therapy
Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy

Estimated Enrollment:	600
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111449

Sponsors and Collaborators

Amgen

Wyeth

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

ClinicalStudyResults website - Results posting for study 20030117 This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

Publications:

Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan R. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006 Jan 7;367(9504):29-35.

Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, Jahreis A. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007 Jun;143(6):719-26.

Krishnan R, Cella D, Leonardi C, Papp K, Gottlieb AB, Dunn M, Chiou CF, Patel V, Jahreis A. Effects of etanercept therapy on fatigue and symptoms of depression in subjects treated for moderate to severe plaque psoriasis for up to 96 weeks. Br J Dermatol. 2007 Dec;157(6):1275-7. Epub 2007 Oct 4. No abstract available.

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20030117
Study First Received:	May 20, 2005
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00111449 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Analgesics, Non-Narcotic
Psoriasis
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 07, 2009