Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01543204
• Other study ID #: 20101145
• Status: Terminated
• Phase: Phase 4
• First received: January 17, 2012
• Last updated: December 5, 2017
• Start date: February 1, 2012
• Est. completion date: May 29, 2015

Study information

• Verified date: December 2017
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: May 29, 2015
• Est. primary completion date: May 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Etanercept
Administered by subcutaneous injection

Locations

Country	Name	City	State
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Markham	Ontario
Canada	Research Site	Peterborough	Ontario
Canada	Research Site	Waterloo	Ontario
Canada	Research Site	Winnipeg	Manitoba
United States	Research Site	Atlanta	Georgia
United States	Research Site	Bakersfield	California
United States	Research Site	Bartlett	Tennessee
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boston	Massachusetts
United States	Research Site	Charleston	South Carolina
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	East Windsor	New Jersey
United States	Research Site	Encino	California
United States	Research Site	Farmington	Connecticut
United States	Research Site	Houston	Texas
United States	Research Site	Irvine	California
United States	Research Site	Jacksonville	Florida
United States	Research Site	Johnston	Rhode Island
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Macon	Georgia
United States	Research Site	Miami	Florida
United States	Research Site	Mobile	Alabama
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Albany	Indiana
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Plainfield	Indiana
United States	Research Site	Plymouth Meeting	Pennsylvania
United States	Research Site	Rochester	New York
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Petersburg	Florida
United States	Research Site	San Francisco	California
United States	Research Site	San Ramon	California
United States	Research Site	Santa Monica	California
United States	Research Site	Skokie	Illinois
United States	Research Site	Tampa	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Verona	New Jersey
United States	Research Site	Walla Walla	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits	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).	Weeks 4, 8, 16, 20 and 24
Secondary	Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits 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).	Weeks 4, 8, 16, 20 and 24
Secondary	Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit	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). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.	Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit	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). The percentage of participants with a score of 0 (clear), 1 (almost clear) or 2 (mild) is reported.	Weeks 4, 8, 12, 16, 20 and 24
Secondary	Static Physician Global Assessment (sPGA) at Each Visit	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).	Weeks 4, 8, 12, 16, 20 and 24
Secondary	Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit	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).	Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With a PASI 50 Response at Each Visit	A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit	A PASI 50 response is a 50% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With a PASI 75 Response at Each Visit	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit	A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With a PASI 90 Response at Each Visit	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit	A PASI 90 response is a 90% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline	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). The percentage of participants with an improvement from baseline of = 1 grade is reported.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline 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). The percentage of participants with an improvement from baseline of = 1 grade is reported.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline	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). The percentage of participants with an improvement from baseline of = 2 grades is reported.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline 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). The percentage of participants with an improvement from baseline of = 2 grades is reported.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status	The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0 to 72, with higher scores indicating greater severity and/or more extensive psoriasis. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and Weeks 4, 8, 12, 16, 20 and 24
Secondary	Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status	A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the participant's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface. Percent change from baseline was calculated as (Baseline Value - Post-baseline Value) / Baseline Value * 100, hence a positive value indicates improvement.	Baseline and weeks 4, 8, 12, 16, 20 and 24
Secondary	Patient Satisfaction With Treatment at Week 12	Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".	Week 12
Secondary	Patient Satisfaction With Treatment at Week 24	Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".	Week 24
Secondary	Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score	The dermatology life quality index (DLQI) is a skin disease-specific instrument to evaluate health-related quality of life. The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answered 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is from 0 (best possible score) to 30 (worst possible score). Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Weeks 12 and 24
Secondary	Change From Baseline in Work Productivity and Activity Impairment (WPAI)	The impact of disease severity on the participant's ability to participate in work and other activities was evaluated using the WPAI. WPAI consists of six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, including absenteeism (work time missed due to health), presenteeism (impairment at work due to health), work productivity loss (overall work impairment due to health), and activity impairment due to health. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Weeks 12 and 24
Secondary	Change From Baseline in Patient Assessment of Itch	The severity of the participants itch was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their itch, with 0 indicating "no itch at all" and 10 indicating "worst itch imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Week 12 and 24
Secondary	Change From Baseline in Patient Assessment of Pain	The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe how much their psoriasis hurts today, with 0 indicating "does not hurt at all" and 10 indicating "worst hurt imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Week 12 and 24
Secondary	Change From Baseline in Patient Assessment of Flaking	The severity of the participants pain was individually assessed by the participant. Participants were asked to circle a number between 0 and 10 to describe their flaking, with 0 indicating "no flaking at all" and 10 indicating "worst flaking imaginable." Change from baseline was calculated as Baseline Value - Post-baseline Value, hence a positive change indicates improvement.	Baseline and Week 12 and 24
Secondary	Number of Participants With Adverse Events	A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.	From first dose of study drug until 30 days after the last dose (up to 28 weeks)

External Links

•   AmgenTrials clinical trials website