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

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ClinicalTrials.gov Identifier: NCT01543204
Recruitment Status : Terminated (Business decision due to slow enrollment)
First Posted : March 2, 2012
Results First Posted : June 27, 2016
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

January 17, 2012
March 2, 2012
May 18, 2016
June 27, 2016
December 29, 2017
February 1, 2012
May 29, 2015   (Final data collection date for primary outcome measure)
  • Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 [ Time Frame: 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).
  • Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 by Anti-adalimumab Antibody Status [ Time Frame: 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).
Efficacy of etanercept [ Time Frame: 12 Weeks ]
To evaluate the efficacy of etanercept at week 12 as measured by static Physician Global Assessment (sPGA) in adult subjects with moderate to severe plaque psoriasis who lost a satisfactory response to adalimumab.
Complete list of historical versions of study NCT01543204 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits [ Time Frame: Weeks 4, 8, 16, 20 and 24 ]
    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).
  • Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at All Other Visits by Anti-adalimumab Antibody Status [ Time Frame: Weeks 4, 8, 16, 20 and 24 ]
    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).
  • Percentage of Participants With an sPGA Score of 0, 1 or 2 at Each Visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With an sPGA Score of 0, 1 or 2 by Anti-adalimumab Antibody Status at Each Visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Static Physician Global Assessment (sPGA) at Each Visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]
    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).
  • Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ]
    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).
  • Percentage of Participants With a PASI 50 Response at Each Visit [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With a PASI 50 Response by Anti-adalimumab Antibody Status at Each Visit [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With a PASI 75 Response at Each Visit [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With a PASI 75 Response by Anti-adalimumab Antibody Status at Each Visit [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With a PASI 90 Response at Each Visit [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With a PASI 90 Response by Anti-adalimumab Antibody Status at Each Visit [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline by Anti-adalimumab Antibody Status [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Percent Change From Baseline in the Percentage of BSA Involved With Psoriasis by Anti-adalimumab Antibody Status [ Time Frame: Baseline and weeks 4, 8, 12, 16, 20 and 24 ]
    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.
  • Patient Satisfaction With Treatment at Week 12 [ Time Frame: Week 12 ]
    Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
  • Patient Satisfaction With Treatment at Week 24 [ Time Frame: Week 24 ]
    Participants indicated their level of satisfaction with the medication's control of psoriasis on a scale from "very dissatisfied" to "very satisfied".
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: Baseline and Weeks 12 and 24 ]
    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.
  • Change From Baseline in Work Productivity and Activity Impairment (WPAI) [ Time Frame: Baseline and Weeks 12 and 24 ]
    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.
  • Change From Baseline in Patient Assessment of Itch [ Time Frame: Baseline and Week 12 and 24 ]
    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.
  • Change From Baseline in Patient Assessment of Pain [ Time Frame: Baseline and Week 12 and 24 ]
    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.
  • Change From Baseline in Patient Assessment of Flaking [ Time Frame: Baseline and Week 12 and 24 ]
    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.
  • Number of Participants With Adverse Events [ Time Frame: From first dose of study drug until 30 days after the last dose (up to 28 weeks) ]
    A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.
  • Safety of etanercept [ Time Frame: 24 Weeks ]
    To evaluate safety of etanercept, as measured by number of subjects with Adverse Events
  • Evaluate and compare efficacy and safety in subjects with and without antibodies to adalimumab [ Time Frame: All Visits (Weeks 4, 8, 12, 16, 20 and 24) ]
    To compare and evaluate etanercept's efficacy, as assessed by sPGA, PASI and BSA and safety, as measured by number of adverse events, in subjects with and without antibodies to adalimumab
  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ]
    To evaulate the effect of treatment with etanercept on patient reported outcomes, as measured by Patient Satisfaction with Treatment
  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ]
    To evaulate the effect of treatment with etanercept on patient reported outcomes, as measured by Dermatology Life Quality index (DLQI)
  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ]
    To evaluate the effect of treatment with etanercept on patient reported outcomes, as measured by improvement in Work Productivity and Activity Impairment Questionnaire (WPAI);
  • Effect of treatment with etanercept on patient reported outcomes [ Time Frame: 12 and 24 Weeks ]
    To evaluate the effect of treatment with etanercept on patient reported outcomes, as measured by Patient assessment of itch score, of pain score and of flaking score.
Not Provided
Not Provided
 
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
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Psoriasis
Drug: Etanercept
Administered by subcutaneous injection
Other Name: Enbrel®
Experimental: Etanercept 50 mg
Participants 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.
Intervention: Drug: Etanercept
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
100
May 29, 2015
May 29, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT01543204
20101145
No
Not Provided
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP