Plaque PsoriasisPhase 4NCT02749370
Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast
A Phase 4 study testing Etanercept in people with Plaque Psoriasis, run by Amgen at 22 sites in United States.
Trial summary
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque 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
- 80 participants
- Where
- 22 sitesUnited States
- Study dates
- 18 May 2016to 6 Dec 2017
- 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
- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- Male or female subject is ≥ 18 years of age at time of screening
- Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator
- Subject has moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline
- Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening
- Subject has failed therapy with apremilast for moderate to severe plaque PsO defined as either (1) failure to achieve adequate clinical response in the opinion of the investigator, (2) loss of adequate clinical response in the opinion of the investigator or (3) intolerability to apremilast in the opinion of the investigator
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- Subject has received at least 4 weeks of apremilast treatment for moderate to severe plaque PsO (this only applies for subjects who are qualifying by failure to achieve adequate clinical response or loss of adequate clinical response, this does not apply for subjects who are qualifying by intolerability to apremilast)
- Subject has not had significant known weight increase or decrease (≥ 10%) during apremilast treatment
- Subject is < 264 lbs at screening and baseline -Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody
- Subject has no known history of tuberculosis.
Who cannot join
- Skin disease related
- -Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO.
- Other Medical Conditions
- Subject has one or more significant concurrent medical conditions per investigator judgment, including the following
- Poorly controlled diabetes
- Chronic kidney disease stage IIIb, IV, or V
Show all 15Show fewer
- Symptomatic heart failure (New York Heart Association class II, III, or IV)
- Myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
- Uncontrolled hypertension
- Severe chronic pulmonary disease (eg, requiring oxygen therapy)
- Multiple sclerosis or any other demyelinating disease
- Liver disease
- Anemia
- Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis (for example, systemic lupus erythematosus with the exception of secondary Sjogren's syndrome)
- Subject has active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, Merkel cell carcinoma or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first dose of investigational product.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Research Site
Ann Arbor, Michigan, 48103
Research Site
Beverly Hills, California, 90211
Research Site
Clarkston, Michigan, 48346
Research Site
Coral Gables, Florida, 33134
Research Site
East Windsor, New Jersey, 08520
Research Site
Fort Gratiot, Michigan, 48059
Research Site
Fountain Valley, California, 92708
Research Site
Greenville, North Carolina, 27834
Research Site
Henderson, Nevada, 89052
Research Site
Houston, Texas, 77082
Research Site
Jacksonville, Florida, 32204
Research Site
Louisville, Kentucky, 40217
Research Site
Macon, Georgia, 31217
Research Site
New York, New York, 10075
Research Site
Newport Beach, California, 92663
Research Site
Rockville, Maryland, 20850
Research Site
San Antonio, Texas, 78218
Research Site
San Ramon, California, 94583
Research Site
Santa Monica, California, 90404
Research Site
Scottsdale, Arizona, 85254
Research Site
St Louis, Missouri, 63117
Research Site
Verona, New Jersey, 07044
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 Failed Therapy With Apremilast
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
Read the detailed description
This is a multicenter, open-label, single-arm, phase 4, estimation study in adults with plaque psoriasis (PsO) who have failed apremilast. The study will consist of a screening period of up to 45 days, a 24-week treatment period with study visits every 4 weeks, and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for adults with plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Etanercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly 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 a PASI 75 Response at Week 12
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 week 12
Secondary outcomes (23)
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 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 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
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
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) 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). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
Measured: Weeks 4, 8, 12, 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
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
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 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
Percent Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Each Visit
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
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe). The total score is the sum of the 8 responses, and ranges from 0 to 32. Higher scores indicate more severe psoriasis.
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Itch From Psoriasis" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Redness of Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Burning of Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Pain From Skin Lesions" Component Score at Each Visit
Participants rated the severity of their psoriasis signs and symptoms on an 8-item questionnaire (itch, redness, scaling, burning, stinging, cracking, flaking, pain) based on the past 7 days. Each item was scored on a 5-point scale from 0 (not at all severe) to 4 (very severe).
Measured: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Patient Assessment of Treatment Satisfaction 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 Assessment of Treatment Satisfaction 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
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at 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). 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 12 and 24
Number of Participants With Adverse Events
Measured: From first dose of etanercept to 30 days after 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 posted25 Apr 2016 (estimated)
- Study start18 May 2016
- Primary completion14 Aug 2017
- Study completion6 Dec 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Plaque 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
- 80 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
- NCT02749370
- Sponsor's protocol ID
- 20150252
- Status last verified
- May 2020
- First submitted
- 14 Mar 2016
- Last updated
- 13 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bagel J, Samad AS, Stolshek BS, Aras GA, Chung JB, Kricorian G, Kircik LH. Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast. J Drugs Dermatol. 2018 Oct 1;17(10):1078-1082.
PubMed 30365588Bagel J, Stolshek BS, Yang Y, Kricorian G, Kircik LH. Evaluation of Patient-Reported Outcomes With Etanercept in Moderate to Severe Plaque Psoriasis Patients After Therapy With Apremilast. J Drugs Dermatol. 2020 Apr 1;19(4):378-383. doi: 10.36849/JDD.2020.4910.
PubMed 32272514
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. 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 Failed Therapy With Apremilast
- ClinicalTrials.gov ID
- NCT02749370
- Acronym / sponsor ID
- 20150252
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 May 2016 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 6 Dec 2017 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Posted 27 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy of etanercept in adults with moderate to severe plaque psoriasis who have failed therapy with apremilast (Otezla).
Detailed description
This is a multicenter, open-label, single-arm, phase 4, estimation study in adults with plaque psoriasis (PsO) who have failed apremilast. The study will consist of a screening period of up to 45 days, a 24-week treatment period with study visits every 4 weeks, and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for adults with plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptParticipants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly 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 (10 listed)
- Subject has provided informed consent prior to initiation of any study specific activities/procedures
- Male or female subject is ≥ 18 years of age at time of screening
- Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator
- Subject has moderate to severe plaque psoriasis (PsO) with involved body surface area (BSA) ≥ 10%, psoriasis area and severity index (PASI) ≥ 10 and static physician's global assessment (sPGA) ≥ 3 at screening and baseline
- Subject is currently receiving treatment with apremilast for moderate to severe plaque PsO or subject has discontinued treatment with apremilast for PsO within the past 3 months prior to screening
Key exclusion criteria (15 listed)
- Skin disease related
- -Subject has active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (for example, eczema) that would interfere with evaluations of the effect of investigational product on PsO.
- Other Medical Conditions
- Subject has one or more significant concurrent medical conditions per investigator judgment, including the following
- Poorly controlled diabetes
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: EnbrelAdministered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks. | Drug | Etanercept |
Primary outcome
Percentage of Participants With a PASI 75 Response at Week 12
Time frame: Baseline and week 12
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.
23 secondary outcomes
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 50 Response 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
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI)
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) 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 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
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 2 Grade Improvement in sPGA From Baseline
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 at Each Visit
Time frame: Baseline and weeks 4, 8, 12, 16, 20, and 24
Psoriasis Symptom Inventory (PSI) Total Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Itch From Psoriasis" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Redness of Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Scaling of Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Burning of Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Stinging of Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Cracking of Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Flaking of Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
PSI "Pain From Skin Lesions" Component Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24
Patient Assessment of Treatment Satisfaction at Week 12
Time frame: Week 12
Patient Assessment of Treatment Satisfaction at Week 24
Time frame: Week 24
Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Weeks 12 and 24
Time frame: Baseline and weeks 12 and 24
Number of Participants With Adverse Events
Time frame: From first dose of etanercept to 30 days after 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 13 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30365588Bagel J, Samad AS, Stolshek BS, Aras GA, Chung JB, Kricorian G, Kircik LH. Open-Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects With Moderate to Severe Plaque Psoriasis Who Have Failed Therapy With Apremilast. J Drugs Dermatol. 2018 Oct 1;17(10):1078-1082.
- Background: PubMed 32272514Bagel J, Stolshek BS, Yang Y, Kricorian G, Kircik LH. Evaluation of Patient-Reported Outcomes With Etanercept in Moderate to Severe Plaque Psoriasis Patients After Therapy With Apremilast. J Drugs Dermatol. 2020 Apr 1;19(4):378-383. doi: 10.36849/JDD.2020.4910.
- 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
22 sites in 1 country: 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 Plaque Psoriasis, run by Amgen at 22 sites in United States.
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 10 inclusion and 15 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: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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 Aug 2018). 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 a PASI 75 Response at Week 12 (time frame: Baseline and week 12). 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 NCT02749370, which also lists 2 linked publications.
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 13 May 2020.