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

This study has been terminated.
(Business decision due to slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01543204
First received: January 17, 2012
Last updated: June 29, 2016
Last verified: June 2016
  Purpose
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.

Condition Intervention Phase
Psoriasis
Drug: Etanercept
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    A treatment-related adverse event is defined as an event that is deemed by the investigator to be related to investigational product.


Enrollment: 64
Study Start Date: February 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Etanercept
Administered by subcutaneous injection
Other Name: Enbrel®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543204

  Show 47 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01543204     History of Changes
Other Study ID Numbers: 20101145 
Study First Received: January 17, 2012
Results First Received: May 18, 2016
Last Updated: June 29, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
plaque psoriasis
etanercept
adalimumab

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Etanercept
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 28, 2016