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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

132

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 125 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Etanercept
Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
Andre navn:
  • Enbrel®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amgen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2015

Primær fullføring (Faktiske)

1. november 2015

Studiet fullført (Faktiske)

1. november 2015

Datoer for studieregistrering

Først innsendt

22. oktober 2014

Først innsendt som oppfylte QC-kriteriene

22. oktober 2014

Først lagt ut (Anslag)

24. oktober 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

29. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 20101177

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Plakk Psoriasis

Kliniske studier på Etanercept

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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