Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Patients With Plaque Psoriasis

NCT02274792 | Completed Phase 4 Results

• 1 other identifier: 20101177
• Study Type: interventional
• Target: 132
• Locations: 2 countries
• Sites: 45

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study

  Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).

  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 (4)

• Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24

  Week 24

• Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12

  Week 12

• Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24

  Week 24

• Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12

  Week 12

Study Arms (1)

Etanercept

EXPERIMENTAL

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.

Drug: Etanercept

Interventions

Etanercept DRUG

Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.

Also known as: Enbrel®

Etanercept

Eligibility Criteria

• Age: 18 Years - 125 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (45)

Research Site

Mobile, Alabama, 36608, United States

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Bakersfield, California, 93309, United States

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Beverly Hills, California, 90212, United States

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Fremont, California, 94538, United States

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Los Angeles, California, 90036, United States

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Denver, Colorado, 80210, United States

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Denver, Colorado, 80220, United States

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Aventura, Florida, 33180, United States

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Miami, Florida, 33144, United States

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Pembroke Pines, Florida, 33028, United States

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Carmel, Indiana, 46032, United States

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Indianapolis, Indiana, 46256, United States

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New Albany, Indiana, 47150, United States

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Overland Park, Kansas, 66202, United States

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Overland Park, Kansas, 66215, United States

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Louisville, Kentucky, 40202, United States

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Owensboro, Kentucky, 42303, United States

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Rockville, Maryland, 20850, United States

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Andover, Massachusetts, 01810, United States

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Worcester, Massachusetts, 01605, United States

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Clarkston, Michigan, 48346, United States

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Omaha, Nebraska, 68144, United States

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Verona, New Jersey, 07044, United States

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Raleigh, North Carolina, 27612, United States

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Cincinnati, Ohio, 45249, United States

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Johnston, Rhode Island, 02919, United States

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Nashville, Tennessee, 37205, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75231, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78249, United States

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Norfolk, Virginia, 23507, United States

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Surrey, British Columbia, V3R 6A7, Canada

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Bathurst, New Brunswick, E2A 4Z9, Canada

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St. John's, Newfoundland and Labrador, A1A 4Y3, Canada

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Barrie, Ontario, L4M 7G1, Canada

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Courtice, Ontario, L1E 3C3, Canada

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Greater Sudbury, Ontario, P3C 1X8, Canada

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Kingston, Ontario, K7L 1S2, Canada

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Markham, Ontario, L3P 1X2, Canada

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Oakville, Ontario, L6J 7W5, Canada

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Toronto, Ontario, M5S 3B4, Canada

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Toronto, Ontario, M8X 1Y9, Canada

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Waterloo, Ontario, N2J 1C4, Canada

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2014
• First Posted: October 24, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 29, 2016
• Results First Posted: December 29, 2016

Record last verified: 2016-10

Locations

US (33); CA (12)