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

2. november 2016 opdateret af: Amgen

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

132

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • 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
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Research Site
    • California
      • Bakersfield, California, Forenede Stater, 93309
        • Research Site
      • Beverly Hills, California, Forenede Stater, 90212
        • Research Site
      • Fremont, California, Forenede Stater, 94538
        • Research Site
      • Los Angeles, California, Forenede Stater, 90036
        • Research Site
    • Colorado
      • Denver, Colorado, Forenede Stater, 80210
        • Research Site
      • Denver, Colorado, Forenede Stater, 80220
        • Research Site
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • Research Site
      • Miami, Florida, Forenede Stater, 33144
        • Research Site
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Research Site
    • Indiana
      • Carmel, Indiana, Forenede Stater, 46032
        • Research Site
      • Indianapolis, Indiana, Forenede Stater, 46256
        • Research Site
      • New Albany, Indiana, Forenede Stater, 47150
        • Research Site
    • Kansas
      • Overland Park, Kansas, Forenede Stater, 66215
        • Research Site
      • Overland Park, Kansas, Forenede Stater, 66202
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Research Site
      • Owensboro, Kentucky, Forenede Stater, 42303
        • Research Site
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20850
        • Research Site
    • Massachusetts
      • Andover, Massachusetts, Forenede Stater, 01810
        • Research Site
      • Worcester, Massachusetts, Forenede Stater, 01605
        • Research Site
    • Michigan
      • Clarkston, Michigan, Forenede Stater, 48346
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68144
        • Research Site
    • New Jersey
      • Verona, New Jersey, Forenede Stater, 07044
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45249
        • Research Site
    • Rhode Island
      • Johnston, Rhode Island, Forenede Stater, 02919
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37205
        • Research Site
    • Texas
      • Bellaire, Texas, Forenede Stater, 77401
        • Research Site
      • Dallas, Texas, Forenede Stater, 75231
        • Research Site
      • Dallas, Texas, Forenede Stater, 75230
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78249
        • Research Site
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 125 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Etanercept
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
Andre navne:
  • Enbrel®

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response During the Study
Tidsramme: 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).
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 24
Tidsramme: Week 24
Week 24
Percentage of Participants With Positive Anti-etanercept Binding Antibody Response at Week 12
Tidsramme: Week 12
Week 12
Percentage of Participants With Positive Anti-etanercept Neutralizing Antibody Response at Week 24
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Faktiske)

1. november 2015

Studieafslutning (Faktiske)

1. november 2015

Datoer for studieregistrering

Først indsendt

22. oktober 2014

Først indsendt, der opfyldte QC-kriterier

22. oktober 2014

Først opslået (Skøn)

24. oktober 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20101177

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Plaque Psoriasis

Kliniske forsøg med Etanercept

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Panama

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner