Clinical trial NCT01543204: Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Psoriasis
Keywords: plaque psoriasis
etanercept
adalimumab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe plaque psoriasis
* Loss of satisfactory response to adalimumab
* Currently receiving or recently discontinued treatment with adalimumab

Exclusion Criteria:

* Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
* Serious medical conditions

Primary outcomes:
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits
timeFrame: Weeks 4, 8, 16, 20 and 24
measure: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status
timeFrame: Weeks 4, 8, 16, 20 and 24
measure: Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Static Physician Global Assessment (sPGA) at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 50 Response at Each Visit
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 75 Response at Each Visit
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 90 Response at Each Visit
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status
timeFrame: Baseline and weeks 4, 8, 12, 16, 20 and 24
measure: Patient Satisfaction With Treatment at Week 12
timeFrame: Week 12
measure: Patient Satisfaction With Treatment at Week 24
timeFrame: Week 24
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline and Weeks 12 and 24
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI)
timeFrame: Baseline and Weeks 12 and 24
measure: Change From Baseline in Patient Assessment of Itch
timeFrame: Baseline and Week 12 and 24
measure: Change From Baseline in Patient Assessment of Pain
timeFrame: Baseline and Week 12 and 24
measure: Change From Baseline in Patient Assessment of Flaking
timeFrame: Baseline and Week 12 and 24
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug until 30 days after the last dose (up to 28 weeks)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Encino
country: United States
facility: Research Site
state: California
city: Irvine
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: San Ramon
country: United States
facility: Research Site
state: California
city: Santa Monica
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Farmington
country: United States
facility: Research Site
state: Connecticut
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Macon
country: United States
facility: Research Site
state: Georgia
city: Skokie
country: United States
facility: Research Site
state: Illinois
city: New Albany
country: United States
facility: Research Site
state: Indiana
city: Plainfield
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: East Windsor
country: United States
facility: Research Site
state: New Jersey
city: Verona
country: United States
facility: Research Site
state: New Jersey
city: Rochester
country: United States
facility: Research Site
state: New York
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Plymouth Meeting
country: United States
facility: Research Site
state: Pennsylvania
city: Johnston
country: United States
facility: Research Site
state: Rhode Island
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Bartlett
country: United States
facility: Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Walla Walla
country: United States
facility: Research Site
state: Washington
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Peterborough
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.