This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Administered by subcutaneous injection
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).
Time frame: 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).
Time frame: Week 12
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).
Time frame: 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
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).
Time frame: Weeks 4, 8, 16, 20 and 24
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.
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Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Bakersfield, California, United States
Research Site
Encino, California, United States
Research Site
Irvine, California, United States
Research Site
Los Angeles, California, United States
Research Site
Sacramento, California, United States
Research Site
San Francisco, California, United States
Research Site
San Ramon, California, United States
...and 37 more locations
Time frame: 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
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.
Time frame: Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Weeks 4, 8, 12, 16, 20 and 24
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).
Time frame: Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
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.
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
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".
Time frame: Week 12
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".
Time frame: Week 24
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.
Time frame: Baseline and Weeks 12 and 24
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.
Time frame: Baseline and Weeks 12 and 24
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.
Time frame: Baseline and Week 12 and 24
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.
Time frame: Baseline and Week 12 and 24
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.
Time frame: Baseline and Week 12 and 24
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.
Time frame: From first dose of study drug until 30 days after the last dose (up to 28 weeks)