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

A Single-arm Study to Assess the Immunogenicity and Safety of Etanercept Produced Using a Modified Process in Subjects With Plaque Psoriasis

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.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Etanercept

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Research Site
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4Z9
      • Research Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Research Site
    • Courtice, Ontario, Canada, L1E 3C3
      • Research Site
    • Kingston, Ontario, Canada, K7L 1S2
      • Research Site
    • Markham, Ontario, Canada, L3P 1X2
      • Research Site
    • Oakville, Ontario, Canada, L6J 7W5
      • Research Site
    • Sudbury, Ontario, Canada, P3C 1X8
      • Research Site
    • Toronto, Ontario, Canada, M5S 3B4
      • Research Site
    • Toronto, Ontario, Canada, M8X 1Y9
      • Research Site
    • Waterloo, Ontario, Canada, N2J 1C4
      • Research Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Research Site
  • California
    • Bakersfield, California, United States, 93309
      • Research Site
    • Beverly Hills, California, United States, 90212
      • Research Site
    • Fremont, California, United States, 94538
      • Research Site
    • Los Angeles, California, United States, 90036
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80210
      • Research Site
    • Denver, Colorado, United States, 80220
      • Research Site
  • Florida
    • Aventura, Florida, United States, 33180
      • Research Site
    • Miami, Florida, United States, 33144
      • Research Site
    • Pembroke Pines, Florida, United States, 33028
      • Research Site
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Research Site
    • Indianapolis, Indiana, United States, 46256
      • Research Site
    • New Albany, Indiana, United States, 47150
      • Research Site
  • Kansas
    • Overland Park, Kansas, United States, 66215
      • Research Site
    • Overland Park, Kansas, United States, 66202
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Research Site
    • Owensboro, Kentucky, United States, 42303
      • Research Site
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Research Site
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Research Site
    • Worcester, Massachusetts, United States, 01605
      • Research Site
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Research Site
  • New Jersey
    • Verona, New Jersey, United States, 07044
      • Research Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Research Site
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Research Site
  • Texas
    • Bellaire, Texas, United States, 77401
      • Research Site
    • Dallas, Texas, United States, 75231
      • Research Site
    • Dallas, Texas, United States, 75230
      • Research Site
    • San Antonio, Texas, United States, 78229
      • Research Site
    • San Antonio, Texas, United States, 78249
      • Research Site
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 125 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Etanercept; Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.; Other Names: Enbrel®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.	Week 24
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12	Samples confirmed to be positive on the binding assay were subsequently tested in a non-cell based assay to determine neutralizing activity against etanercept.	Week 12

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (Estimate): October 24, 2014

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: November 2, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Etanercept
• Other Study ID Numbers: 20101177