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A Study To Monitor Long-Term Treatment With PF-00547659 (OPERA II)

11. maj 2021 opdateret af: Shire

A Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II

This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The rationale for conducting this open-label extension (OLE) study is primarily to evaluate long term safety of PF 00547659. This protocol also provides the opportunity for continued treatment for subjects responding to treatment from the feeder study. It also provides an opportunity for initial treatment for subjects randomized to placebo in the feeder study. This is a multi center Phase 2, open label, safety extension study for feeder studies which evaluate PF 00546759 in subjects with moderate to severe Crohn's disease. Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008 with a clinical response, as defined by that protocol, will also be eligible for this study and treated as "responders". All subjects entering this study must have discontinued immunosuppressant therapy.

Subjects entering this study will be given a 75 mg SC dose at baseline and then every 4 weeks through Week 72. After the active treatment period, the subjects will enter a 24 month follow up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

268

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Brussels, Belgien, B-1070
        • Hospital Erasme
      • Leuven, Belgien, B-3000
        • UZ Gasthuisberg
      • Leuven, Belgien, B-3000
        • UZ Gasthuisberg - Pharmacy
      • Liege, Belgien, 4000
        • Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman
      • Mouscron, Belgien, 7700
        • Centre Hospitalier De Mouscron
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Inc.
  • Forenede Stater
    • California
      • La Jolla, California, Forenede Stater, 92037
        • UCSD Medical Center - Thorton Hospital
      • Orange, California, Forenede Stater, 92868
        • Community Clinical Trials
      • Orange, California, Forenede Stater, 92868
        • GastroDiagnostics
    • Colorado
      • Lafayette, Colorado, Forenede Stater, 80026
        • Clinical Research of the Rockies
      • Thornton, Colorado, Forenede Stater, 80229
        • Rocky Mountain Gastroenterology Associates
      • Thornton, Colorado, Forenede Stater, 80229
        • Rmga - Rmcr
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20006
        • MGG Group Co., Inc.
    • Florida
      • Largo, Florida, Forenede Stater, 33777
        • Florida Center for Gastroenterology
      • Miami, Florida, Forenede Stater, 33136
        • Sylvester Comprehensive Cancer Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Hospital
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Hospital and Clinic
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Crohn's and Colitis Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Hospital and Clinic (IP Shipment Only)
      • Orlando, Florida, Forenede Stater, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, Forenede Stater, 32806
        • Citrus Ambulatory Surgery Center
    • Iowa
      • Clive, Iowa, Forenede Stater, 50325
        • Iowa Digestive Disease Center
      • Clive, Iowa, Forenede Stater, 50325
        • Iowa Endoscopy Center (Colonoscopy Only)
      • Clive, Iowa, Forenede Stater, 50325
        • Heartland Medical Research, Inc.
    • Maryland
      • Chevy Chase, Maryland, Forenede Stater, 20815
        • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
    • Massachusetts
      • Worcester, Massachusetts, Forenede Stater, 01655
        • UMass Memorial Medical Center
      • Worcester, Massachusetts, Forenede Stater, 01655
        • University of Massachusetts Worcester
    • Michigan
      • Troy, Michigan, Forenede Stater, 48098
        • Center for Digestive Health
      • Troy, Michigan, Forenede Stater, 48098
        • Surgical Centers of Michigan
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Surgery Center of Columbia
      • Mexico, Missouri, Forenede Stater, 65265
        • Audrain Medical Center
      • Mexico, Missouri, Forenede Stater, 65265
        • Center for Digestive and Liver Diseases, Inc.
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Barnes-Jewish Hospital
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Center for Advanced Medicine
      • Saint Louis, Missouri, Forenede Stater, 63108
        • Barnes-Jewish Hospital - Investigational Drug Services
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Medical College
      • Flushing, New York, Forenede Stater, 11355
        • New York Hospital Queens
      • Great Neck, New York, Forenede Stater, 11021
        • Long Island Clinical Research Associates, LLP
      • Great Neck, New York, Forenede Stater, 11021
        • Nassau Gastroenterology Associates Office Based Surgery
      • Great Neck, New York, Forenede Stater, 11021
        • Nassau Gastroenterology Associates, P.C.
      • Great Neck, New York, Forenede Stater, 11021
        • North Shore Primary Care, P.C.
      • New York, New York, Forenede Stater, 10075
        • Lenox Hill Endoscopy Center
      • New York, New York, Forenede Stater, 11230
        • Synergy First
      • Poughkeepsie, New York, Forenede Stater, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • North Carolina Memorial Hospital Endoscopy Center
      • Chapel Hill, North Carolina, Forenede Stater, 27517
        • UNC Hospitals Endoscopy
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Unc Hospitals
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • CTRC Hospital, UNC Memorial Hospital
      • Hillsborough, North Carolina, Forenede Stater, 27278
        • Hillsborough Campus
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington
    • Wisconsin
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Allegiance Research Specialists
  • Frankrig
      • Clichy, Frankrig, 92110
        • Hopital Beaujon
      • Lille, Frankrig, 59037
        • CHRU de Lille, Pharamcie Centrale
      • Lille, Frankrig, 59037
        • CIC - Hopital Cardiologique
      • Lille Cedex, Frankrig, 59037
        • Hopital Huriez, CHRU de Lille
      • NICE Cedex 3, Frankrig, 06202
        • Hopital de l'Archet 2 - CHU de Nice
      • Paris, Frankrig, 75010
        • Hôpital Saint-Louis
      • St Priest En Jarez, Frankrig, 42270
        • Hôpital Nord
      • Toulouse Cedex 9, Frankrig, 31059
        • Hopital Rangueil
  • Holland
      • Amsterdam, Holland, 1105 AZ
        • Academic Medical Center
      • Groningen, Holland, 9713GZ
        • University Medical Center Groningen
      • Maastricht, Holland, 6229 HX
        • Maastricht University Medical Center
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
    • Gunma
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Center
    • Kanagawa
      • Yokohama-Shi, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
    • Tokyo
      • Minato-Ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
    • Toyko
      • Aomori, Toyko, Japan, 036-8545
        • National Hospital Organization Hirosaki National Hospital
  • Korea, Republikken
      • Busan, Korea, Republikken, 602-739
        • Pusan National University Hospital
      • Daegu, Korea, Republikken, 705-717
        • Yeungnam University Hospital
      • Seoul, Korea, Republikken, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republikken, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republikken, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republikken, 110-746
        • Kangbuk Samsung Hospital
  • Norge
      • Gjettum, Norge, 1346
        • Sykehusapoteket Asker og Baerum
      • Oslo, Norge, 0424
        • Oslo Universitetssykehus
      • Oslo, Norge, 0440
        • Lovisenberg diakonale sykehus
      • Rud, Norge, 1309
        • Vestre Viken HF
  • Polen
      • Bydgoszcz, Polen, 85-168
        • Centrum Endoskopii Zabiegowej
      • Lodz, Polen, 90-302
        • NZOZ Centrum Medyczne Szpital Sw. Rodziny
      • Warszawa, Polen, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
      • Warszawa, Polen, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
      • Wroclaw, Polen, 53-114
        • LexMedica
  • Serbien
      • Belgrade, Serbien, 11000
        • Military Medical Academy
      • Belgrade, Serbien, 11080
        • Clinical Hospital Centre Bezanijska Kosa
      • Zemun, Serbien, 11080
        • Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology
  • Slovakiet
      • Bratislava, Slovakiet, 831 04
        • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
      • Bratislava, Slovakiet, 851 01
        • Medak s.r.o.
      • Nitra, Slovakiet, 949 01
        • KM Management spol. s r.o.
      • Nove Mesto nad Vahom, Slovakiet, 915 01
        • Synergy group, a.s.
  • Spanien
      • Madrid, Spanien, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spanien, 28007
        • Hospital General Universitario Gregorio Marañón
    • Barcelona
      • Sabadell, Barcelona, Spanien, 08208
        • Corporació Sanitària Parc Taulí de Sabadell
    • Cataluna
      • Sabadell, Cataluna, Spanien, 08208
        • Corporació Sanitària Parc Taulí de Sabadell
    • Madrid
      • Majadahonda, Madrid, Spanien, 28222
        • Hospital Puerta de Hierro Majadahonda
  • Sydafrika
    • Gauteng, South Africa
      • Johannesburg, Gauteng, South Africa, Sydafrika, 2193
        • Wits Clinical Research
    • KWA ZULU Natal
      • Durban, KWA ZULU Natal, Sydafrika, 4091
        • Parklands Medical Centre
    • Western CAPE
      • Cape Town, Western CAPE, Sydafrika, 7708
        • Kingsbury Hospital
  • Tyskland
      • Berlin, Tyskland, 13353
        • Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
      • Berlin, Tyskland, 10117
        • "Charite - Campus Berlin Mitte Medizinische Klinik
      • Halle, Tyskland, 06120
        • Krankenhaus Martha-Maria Halle-Doelau gGmbH
      • Kiel, Tyskland, 24105
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
      • Luebeck, Tyskland, 23538
        • Universitaetsfrauenklinikum Schleswig-Holstein
      • Minden, Tyskland, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Regensburg, Tyskland, 93042
        • Universitaetsklinik Regensburg
    • Baden-wuerttemberg
      • Stuttgart, Baden-wuerttemberg, Tyskland, 70376
        • Robert Bosch Krankenhaus GmbH
      • Ulm, Baden-wuerttemberg, Tyskland, 89081
        • Universitaetsklinikum Ulm
  • Østrig
      • Wien, Østrig, 1090
        • AKH Wien
      • Wien, Østrig, 1090
        • AKH Wien Universitaetsklinik fuer Innere Medizin III

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 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects between 18 and 76 years of age.
  • Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study.
  • Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Open-Label Treatment
Subjects eligible for this study will have completed the 12 week double blind induction period in study A7281006 and will be stratified by responders or non responders based on change in CDAI in that study, without unblinding treatment assignment from study A7281006. Additionally, subjects who have completed study A7281008
Medicin: PF-00547659
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Tidsramme: From start of study treatment up to Week 72 (Treatment Period)
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
From start of study treatment up to Week 72 (Treatment Period)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
Tidsramme: Baseline up to Week 96
Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (>=) 4.64 at at least one of the time points.
Baseline up to Week 96
Serum Trough Concentrations of PF-00547659 Versus Time
Tidsramme: Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96
Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.
Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96

Samarbejdspartnere og efterforskere

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

Sponsor

Shire

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.

Generelle publikationer

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 (Faktiske)

1. juli 2011

Primær færdiggørelse (Faktiske)

27. juli 2016

Studieafslutning (Faktiske)

27. juli 2016

Datoer for studieregistrering

Først indsendt

26. januar 2011

Først indsendt, der opfyldte QC-kriterier

16. februar 2011

Først opslået (Skøn)

17. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A7281007
  • 2010-024638-48 (EudraCT nummer)

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 .

Abonner