Study to Evaluate the Efficacy of Etanercept Treatment in Adults Who Failed Therapy With Apremilast
NCT ID: NCT02749370
Last Updated: 2020-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
80 participants
INTERVENTIONAL
2016-05-18
2017-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Etanercept
Participants received etanercept 50 mg subcutaneously twice weekly for 12 weeks followed by 50 mg once weekly for an additional 12 weeks.
Etanercept
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
Interventions
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Etanercept
Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
Exclusion Criteria
-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
* 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.
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Scottsdale, Arizona, United States
Research Site
Beverly Hills, California, United States
Research Site
Fountain Valley, California, United States
Research Site
Newport Beach, California, United States
Research Site
San Ramon, California, United States
Research Site
Santa Monica, California, United States
Research Site
Coral Gables, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Macon, Georgia, United States
Research Site
Louisville, Kentucky, United States
Research Site
Rockville, Maryland, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Clarkston, Michigan, United States
Research Site
Fort Gratiot, Michigan, United States
Research Site
St Louis, Missouri, United States
Research Site
Henderson, Nevada, United States
Research Site
East Windsor, New Jersey, United States
Research Site
Verona, New Jersey, United States
Research Site
New York, New York, United States
Research Site
Greenville, North Carolina, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
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References
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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.
Bagel 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20150252
Identifier Type: -
Identifier Source: org_study_id
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