Study Stopped
Business decision due to slow enrollment
Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab
Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab
1 other identifier
interventional
64
2 countries
47
Brief Summary
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2012
Typical duration for phase_4
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2015
CompletedResults Posted
Study results publicly available
June 27, 2016
CompletedDecember 29, 2017
December 1, 2017
3.3 years
January 17, 2012
May 18, 2016
December 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Week 12
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status
The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Week 12
Secondary Outcomes (28)
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
Weeks 4, 8, 16, 20 and 24
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
Weeks 4, 8, 16, 20 and 24
Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
Weeks 4, 8, 12, 16, 20 and 24
Static Physician Global Assessment (sPGA) at Each Visit
Weeks 4, 8, 12, 16, 20 and 24
- +23 more secondary outcomes
Study Arms (1)
Etanercept 50 mg
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Moderate to severe plaque psoriasis
- Loss of satisfactory response to adalimumab
- Currently receiving or recently discontinued treatment with adalimumab
You may not qualify if:
- Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
- Serious medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (47)
Research Site
Birmingham, Alabama, 35205, United States
Research Site
Mobile, Alabama, 36609, United States
Research Site
Phoenix, Arizona, 85044, United States
Research Site
Bakersfield, California, 93309, United States
Research Site
Encino, California, 91436, United States
Research Site
Irvine, California, 92697, United States
Research Site
Los Angeles, California, 90045, United States
Research Site
Sacramento, California, 95816, United States
Research Site
San Francisco, California, 94118, United States
Research Site
San Ramon, California, 94583, United States
Research Site
Santa Monica, California, 90404, United States
Research Site
Denver, Colorado, 80220, United States
Research Site
Farmington, Connecticut, 06030, United States
Research Site
Jacksonville, Florida, 32204, United States
Research Site
Miami, Florida, 33136, United States
Research Site
St. Petersburg, Florida, 33708, United States
Research Site
Tampa, Florida, 33607, United States
Research Site
Tampa, Florida, 33609, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Macon, Georgia, 31217, United States
Research Site
Skokie, Illinois, 60077, United States
Research Site
New Albany, Indiana, 47150, United States
Research Site
Plainfield, Indiana, 46168, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
New Orleans, Louisiana, 70112, United States
Research Site
Boston, Massachusetts, 02115, United States
Research Site
St Louis, Missouri, 63117, United States
Research Site
Omaha, Nebraska, 68144, United States
Research Site
East Windsor, New Jersey, 08520, United States
Research Site
Verona, New Jersey, 07044, United States
Research Site
Rochester, New York, 14625, United States
Research Site
Pittsburgh, Pennsylvania, 15213, United States
Research Site
Plymouth Meeting, Pennsylvania, 19462, United States
Research Site
Johnston, Rhode Island, 02919, United States
Research Site
Charleston, South Carolina, 29414, United States
Research Site
Bartlett, Tennessee, 38134, United States
Research Site
Knoxville, Tennessee, 37917, United States
Research Site
Nashville, Tennessee, 37215, United States
Research Site
Dallas, Texas, 75231, United States
Research Site
Houston, Texas, 77004, United States
Research Site
Norfolk, Virginia, 23507, United States
Research Site
Walla Walla, Washington, 99362, United States
Research Site
Winnipeg, Manitoba, R3C 0N2, Canada
Research Site
Halifax, Nova Scotia, B3H 0A2, Canada
Research Site
Markham, Ontario, L3P 1X2, Canada
Research Site
Peterborough, Ontario, K9J 1Z2, Canada
Research Site
Waterloo, Ontario, N2J 1C4, Canada
Related Publications (1)
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.
PMID: 28196270BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2012
First Posted
March 2, 2012
Study Start
February 1, 2012
Primary Completion
May 29, 2015
Study Completion
May 29, 2015
Last Updated
December 29, 2017
Results First Posted
June 27, 2016
Record last verified: 2017-12