PsoriasisPhase 4NCT01543204
Etanercept Treatment in Patients With Moderate to Severe Plaque Psoriasis Who Lost Response to Adalimumab
A Phase 4 study testing Etanercept in people with Psoriasis, run by Amgen at 47 sites in 2 countries.
Trial summary
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 47 sitesin 2 countries
- Study dates
- 1 Feb 2012to 29 May 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe plaque psoriasis
- Loss of satisfactory response to adalimumab
- Currently receiving or recently discontinued treatment with adalimumab
Who cannot join
- Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
- Serious medical conditions
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States42 sites
Research Site
Atlanta, Georgia, 30342
Research Site
Bakersfield, California, 93309
Research Site
Bartlett, Tennessee, 38134
Research Site
Birmingham, Alabama, 35205
Research Site
Boston, Massachusetts, 02115
Research Site
Charleston, South Carolina, 29414
Research Site
Dallas, Texas, 75231
Research Site
Denver, Colorado, 80220
Research Site
East Windsor, New Jersey, 08520
Research Site
Encino, California, 91436
Research Site
Farmington, Connecticut, 06030
Research Site
Houston, Texas, 77004
Research Site
Irvine, California, 92697
Research Site
Jacksonville, Florida, 32204
Research Site
Johnston, Rhode Island, 02919
Research Site
Knoxville, Tennessee, 37917
Research Site
Los Angeles, California, 90045
Research Site
Louisville, Kentucky, 40202
Research Site
Macon, Georgia, 31217
Research Site
Miami, Florida, 33136
Research Site
Mobile, Alabama, 36609
Research Site
Nashville, Tennessee, 37215
Research Site
New Albany, Indiana, 47150
Research Site
New Orleans, Louisiana, 70112
Research Site
Norfolk, Virginia, 23507
Research Site
Omaha, Nebraska, 68144
Research Site
Phoenix, Arizona, 85044
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Plainfield, Indiana, 46168
Research Site
Plymouth Meeting, Pennsylvania, 19462
Research Site
Rochester, New York, 14625
Research Site
Sacramento, California, 95816
Research Site
San Francisco, California, 94118
Research Site
San Ramon, California, 94583
Research Site
Santa Monica, California, 90404
Research Site
Skokie, Illinois, 60077
Research Site
St Louis, Missouri, 63117
Research Site
St. Petersburg, Florida, 33708
Research Site
Tampa, Florida, 33607
Research Site
Tampa, Florida, 33609
Research Site
Verona, New Jersey, 07044
Research Site
Walla Walla, Washington, 99362
Canada5 sites
Research Site
Halifax, Nova Scotia, B3H 0A2
Research Site
Markham, Ontario, L3P 1X2
Research Site
Peterborough, Ontario, K9J 1Z2
Research Site
Waterloo, Ontario, N2J 1C4
Research Site
Winnipeg, Manitoba, R3C 0N2
About this study
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
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.
- Conditions
- Psoriasis
- Being tested
- Etanercept
- Keywords
- plaque psoriasis, etanercept, adalimumab
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel®
Administered by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Etanercept 50 mg | Experimental | 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. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Week 12
Secondary outcomes (28)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From first dose of study drug until 30 days after the last dose (up to 28 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study start1 Feb 2012
- Primary completion29 May 2015
- Study completion29 May 2015
Why it stopped: Business decision due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543204
- Sponsor's protocol ID
- 20101145
- Status last verified
- Dec 2017
- First submitted
- 17 Jan 2012
- Last updated
- 29 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 28196270
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01543204
- Acronym / sponsor ID
- 20101145
- Conditions
- Psoriasis
- Keywords
- plaque psoriasis, etanercept, adalimumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision due to slow enrollment
- Enrolment
- 64 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 29 May 2015 (actual)
- Study completion
- 29 May 2015 (actual)
- First posted
- 2 Mar 2012 (estimated)
- Results
- Posted 27 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept 50 mg | Experimental | Drug: EtanerceptParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate to severe plaque psoriasis
- Loss of satisfactory response to adalimumab
- Currently receiving or recently discontinued treatment with adalimumab
Key exclusion criteria (2 listed)
- Active skin conditions that would interfere with evaluations of the effect of investigational product on psoriasis
- Serious medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: Enbrel®Administered by subcutaneous injection | Drug | Etanercept 50 mg |
Primary outcome
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).
28 secondary outcomes
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
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
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
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
Static Physician Global Assessment (sPGA) at Each Visit
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Static Physician Global Assessment (sPGA) by Anti-adalimumab Antibody Status at Each Visit
Time frame: Weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 50 Response at Each Visit
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
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 75 Response at Each Visit
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
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Percentage of Participants With a PASI 90 Response at Each Visit
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
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
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
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
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
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and Weeks 4, 8, 12, 16, 20 and 24
Percent Change From Baseline in PASI by Anti-adalimumab Antibody Status
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
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
Time frame: Baseline and weeks 4, 8, 12, 16, 20 and 24
Patient Satisfaction With Treatment at Week 12
Time frame: Week 12
Patient Satisfaction With Treatment at Week 24
Time frame: Week 24
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Time frame: Baseline and Weeks 12 and 24
Change From Baseline in Work Productivity and Activity Impairment (WPAI)
Time frame: Baseline and Weeks 12 and 24
Change From Baseline in Patient Assessment of Itch
Time frame: Baseline and Week 12 and 24
Change From Baseline in Patient Assessment of Pain
Time frame: Baseline and Week 12 and 24
Change From Baseline in Patient Assessment of Flaking
Time frame: Baseline and Week 12 and 24
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28196270Bagel 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.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Etanercept in people with Psoriasis, run by Amgen at 47 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.