Back to resultsEvaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Etanercept
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00111449
First Posted
May 20, 2005
Last Updated
May 13, 2013
Sponsor
Amgen
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00111449
Brief Title
Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
Official Title
A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Psoriasis, adults, skin, Phase 3, clinical trial, Amgen, etanercept, Enbrel®, moderate, severe
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Etanercept
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Dermatology Live Quality Index (DLQI) response at week 12
Title
Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
Title
Psoriasis pain (VAS) at week 12
Title
Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
Title
PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
Title
Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
Title
Adverse events, infections injection site reactions during long-term therapy
Title
Serious adverse events and infections during long-term therapy
Title
Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17916204
Citation
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. doi: 10.1111/j.1365-2133.2007.08205.x. Epub 2007 Oct 4. No abstract available.
Results Reference
result
PubMed Identifier
16399150
Citation
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. doi: 10.1016/S0140-6736(05)67763-X.
Results Reference
result
PubMed Identifier
17576937
Citation
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. doi: 10.1001/archderm.143.6.719.
Results Reference
result
PubMed Identifier
23465037
Citation
Papp K, Poulin Y, Vieira A, Shelton J, Poulin-Costello M. Disease characteristics in patients with and without psoriatic arthritis treated with etanercept. J Eur Acad Dermatol Venereol. 2014 May;28(5):581-9. doi: 10.1111/jdv.12138. Epub 2013 Mar 7.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_916_ENBREL_20030117.pdf
Description
To access clinical trial results information click on this link
URL
http://www.enbrel.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
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