Clinical trial NCT02274792: Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis
Official title: A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 125
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn more about the immune response to etanercept produced using a modified process in patients with plaque psoriasis.

Detailed description: This is a multicenter, open-label, single-arm phase 4 study in patients with plaque psoriasis who are etanercept-naïve and who are not receiving methotrexate therapy. The study will consist of a screening period of up to 30 days, a 24-week treatment period and a 30-day follow-up period for safety. Etanercept dosing will follow the recommended label dosing for patients with plaque psoriasis.

Eligibility criteria: Inclusion Criteria:

* 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 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 active erythrodermic, pustular, guttate psoriasis, or medication induced psoriasis, or other skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of investigational product on psoriasis.
* 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.

Primary outcomes:
measure: Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study
timeFrame: Blood samples were collected for anti-etanercept antibody analysis before the administration of etanercept at baseline (day 1) and at week 12 and week 24.
Secondary outcomes:
measure: Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Fremont
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Carmel
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: New Albany
country: United States
facility: Research Site
state: Indiana
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Research Site
state: Kentucky
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Andover
country: United States
facility: Research Site
state: Massachusetts
city: Worcester
country: United States
facility: Research Site
state: Massachusetts
city: Clarkston
country: United States
facility: Research Site
state: Michigan
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Verona
country: United States
facility: Research Site
state: New Jersey
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Johnston
country: United States
facility: Research Site
state: Rhode Island
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Bellaire
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Surrey
country: Canada
facility: Research Site
state: British Columbia
city: Bathurst
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Courtice
country: Canada
facility: Research Site
state: Ontario
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Oakville
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: