Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis
NCT ID: NCT02274792
Last Updated: 2016-12-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2015-01-31
2015-11-30
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 a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
Etanercept
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
Interventions
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Etanercept
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator.
* Subject has involved body surface area (BSA) ≥ 10%, static physician global assessment (sPGA) ≥ 3, and Psoriasis Area and Severity Index (PASI) ≥ 10 at screening and at baseline.
* Subject is naïve to etanercept.
* Subject is a candidate for treatment with etanercept in the opinion of the investigator in addition to the caring physician's intent to initiate treatment with etanercept, as applicable.
* Subject is able to self-inject etanercept or have a designee who can do so.
* Subject has not used methotrexate within 4-weeks from the first dose of etanercept.
* Subject has a negative test for hepatitis B surface antigen, hepatitis B core antibody and hepatitis C antibody.
* Subject has no known history of active tuberculosis.
* Subject has a negative test for tuberculosis during screening
* Subject, if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative serum pregnancy test ≤ 4 weeks from starting etanercept and a negative urine pregnancy test at baseline (day 1).
Exclusion Criteria
* Subject has any uncontrolled, clinically significant systemic disease (e.g., renal failure, heart failure, hypertension, pulmonary or liver disease, diabetes, anemia).
* Myocardial infarction or unstable angina pectoris within the last year.
* Major chronic inflammatory disease or connective tissue disease other than psoriasis and/or psoriatic arthritis.
* Multiple sclerosis or any other demyelinating disease.
* 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 etanercept. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.
* Known history of alcoholic hepatitis or immunodeficiency syndromes including human Immunodeficiency virus (HIV) infection.
* Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to first dose of etanercept.
* Subject has a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infectives within 8 weeks prior to first dose of etanercept.
* Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
* Subject has any condition that could, in the opinion of the investigator, compromise the subject's ability to give written consent and/or comply with the study procedures, such as a history of substance abuse or a psychiatric condition.
18 Years
125 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
Mobile, Alabama, United States
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Bakersfield, California, United States
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Beverly Hills, California, United States
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Fremont, California, United States
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Los Angeles, California, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Aventura, Florida, United States
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Miami, Florida, United States
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Pembroke Pines, Florida, United States
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Carmel, Indiana, United States
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Indianapolis, Indiana, United States
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New Albany, Indiana, United States
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Overland Park, Kansas, United States
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Overland Park, Kansas, United States
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Louisville, Kentucky, United States
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Owensboro, Kentucky, United States
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Rockville, Maryland, United States
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Andover, Massachusetts, United States
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Worcester, Massachusetts, United States
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Clarkston, Michigan, United States
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Omaha, Nebraska, United States
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Verona, New Jersey, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Johnston, Rhode Island, United States
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Nashville, Tennessee, United States
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Bellaire, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Norfolk, Virginia, United States
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Surrey, British Columbia, Canada
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Bathurst, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Barrie, Ontario, Canada
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Courtice, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Kingston, Ontario, Canada
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Markham, Ontario, Canada
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Oakville, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Waterloo, Ontario, Canada
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101177
Identifier Type: -
Identifier Source: org_study_id