Back to resultsEvaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
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, extension
Eligibility Criteria
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) Exclusion Criteria: Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit Pregnant or breast-feeding females Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
50 mg
100 mg
Arm Description
50 mg once weekly
50 mg twice weekly
Outcomes
Primary Outcome Measures
Subject incidence of adverse events, including infectious episodes
Changes from baseline in laboratory values
Secondary Outcome Measures
Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study
Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis
Patient Global Assessment of psoriasis
Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores
Changes from baseline in SF-36 Health Survey scores
Full Information
NCT ID
NCT00111436
First Posted
May 20, 2005
Last Updated
April 24, 2013
Sponsor
Amgen
Collaborators
Immunex Corporation, Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00111436
Brief Title
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Official Title
An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Immunex Corporation, Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
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.
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, extension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
912 (Actual)
8. Arms, Groups, and Interventions
Arm Title
50 mg
Arm Type
Experimental
Arm Description
50 mg once weekly
Arm Title
100 mg
Arm Type
Experimental
Arm Description
50 mg twice weekly
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
Enbrel 50 mg once weekly or 50 mg twice weekly
Primary Outcome Measure Information:
Title
Subject incidence of adverse events, including infectious episodes
Time Frame
72 weeks
Title
Changes from baseline in laboratory values
Time Frame
72 weeks
Secondary Outcome Measure Information:
Title
Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study
Time Frame
72 weeks
Title
Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis
Time Frame
72 weeks
Title
Patient Global Assessment of psoriasis
Time Frame
72 weeks
Title
Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores
Time Frame
72 weeks
Title
Changes from baseline in SF-36 Health Survey scores
Time Frame
72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Exclusion Criteria:
Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
Pregnant or breast-feeding females
Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the 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
17199580
Citation
Elewski B, Leonardi C, Gottlieb AB, Strober BE, Simiens MA, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. Br J Dermatol. 2007 Jan;156(1):138-42. doi: 10.1111/j.1365-2133.2006.07585.x.
Results Reference
result
PubMed Identifier
20684143
Citation
Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010 Aug;9(8):928-37.
Results Reference
result
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_20030115.pdf
Description
To access clinical trial results information click on this link
Learn more about this trial
Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
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