Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02274792
Recruitment Status : Completed
First Posted : October 24, 2014
Results First Posted : December 29, 2016
Last Update Posted : December 29, 2016
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Etanercept Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Etanercept

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 Name: Enbrel®




Primary Outcome Measures :
  1. Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study [ Time Frame: 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. ]
    Seroreactivity to etanercept was evaluated using a validated enzyme-linked immunosorbent assay (ELISA).


Secondary Outcome Measures :
  1. Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24 [ Time Frame: Week 24 ]
  2. Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12 [ Time Frame: Week 12 ]
  3. Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24 [ Time Frame: 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.

  4. Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 12 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 125 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02274792


Locations
Layout table for location information
United States, Alabama
Research Site
Mobile, Alabama, United States, 36608
United States, California
Research Site
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
United States, Colorado
Research Site
Denver, Colorado, United States, 80210
Research Site
Denver, Colorado, United States, 80220
United States, Florida
Research Site
Aventura, Florida, United States, 33180
Research Site
Miami, Florida, United States, 33144
Research Site
Pembroke Pines, Florida, United States, 33028
United States, Indiana
Research Site
Carmel, Indiana, United States, 46032
Research Site
Indianapolis, Indiana, United States, 46256
Research Site
New Albany, Indiana, United States, 47150
United States, Kansas
Research Site
Overland Park, Kansas, United States, 66202
Research Site
Overland Park, Kansas, United States, 66215
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40202
Research Site
Owensboro, Kentucky, United States, 42303
United States, Maryland
Research Site
Rockville, Maryland, United States, 20850
United States, Massachusetts
Research Site
Andover, Massachusetts, United States, 01810
Research Site
Worcester, Massachusetts, United States, 01605
United States, Michigan
Research Site
Clarkston, Michigan, United States, 48346
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68144
United States, New Jersey
Research Site
Verona, New Jersey, United States, 07044
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45249
United States, Rhode Island
Research Site
Johnston, Rhode Island, United States, 02919
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37205
United States, Texas
Research Site
Bellaire, Texas, United States, 77401
Research Site
Dallas, Texas, United States, 75230
Research Site
Dallas, Texas, United States, 75231
Research Site
San Antonio, Texas, United States, 78229
Research Site
San Antonio, Texas, United States, 78249
United States, Virginia
Research Site
Norfolk, Virginia, United States, 23507
Canada, British Columbia
Research Site
Surrey, British Columbia, Canada, V3R 6A7
Canada, New Brunswick
Research Site
Bathurst, New Brunswick, Canada, E2A 4Z9
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
Canada, Ontario
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
Layout table for investigator information
Study Director: MD Amgen

Additional Information:
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02274792    
Other Study ID Numbers: 20101177
First Posted: October 24, 2014    Key Record Dates
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors