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

11 maggio 2021 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

268

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Shire

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2011

Completamento primario (Effettivo)

27 luglio 2016

Completamento dello studio (Effettivo)

27 luglio 2016

Date di iscrizione allo studio

Primo inviato

26 gennaio 2011

Primo inviato che soddisfa i criteri di controllo qualità

16 febbraio 2011

Primo Inserito (Stima)

17 febbraio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2021

Ultimo verificato

1 maggio 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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