A Study To Monitor Long-Term Treatment With PF-00547659

Last updated: May 11, 2021
Sponsor: Shire
Overall Status: Completed

Phase

2

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Bowel Dysfunction

Treatment

PF-00547659

Clinical Study ID

NCT01298492
A7281007
2010-024638-48
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 havedemonstrated a clinical response as defined by that protocol.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 268
Treatment Group(s): 1
Primary Treatment: PF-00547659
Phase: 2
Study Start date:
July 01, 2011
Estimated Completion Date:
July 27, 2016

Study Description

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.

Connect with a study center

  • Pfizer Investigational Site

    Linz, 4020
    Austria

    Site Not Available

  • Pfizer Investigational Site

    St. Poelten, 3100
    Austria

    Site Not Available

  • Pfizer Investigational Site

    St. Polten, 3100
    Austria

    Site Not Available

  • AKH Wien

    Wien, 1090
    Austria

    Site Not Available

  • AKH Wien Universitaetsklinik fuer Innere Medizin III

    Wien, 1090
    Austria

    Site Not Available

  • Hospital Erasme

    Brussels, B-1070
    Belgium

    Site Not Available

  • UZ Gasthuisberg

    Leuven, B-3000
    Belgium

    Site Not Available

  • UZ Gasthuisberg - Pharmacy

    Leuven, B-3000
    Belgium

    Site Not Available

  • Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman

    Liege, 4000
    Belgium

    Site Not Available

  • Centre Hospitalier de Mouscron

    Mouscron, 7700
    Belgium

    Site Not Available

  • Pfizer Investigational Site

    Sofia, 1000
    Bulgaria

    Site Not Available

  • Pfizer Investigational Site

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Oshawa Clinic

    Oshawa, Ontario L1H 1B9
    Canada

    Site Not Available

  • Toronto Digestive Disease Associates Inc.

    Vaughan, Ontario L4L 4Y7
    Canada

    Site Not Available

  • Hopital Rangueil

    Toulouse, Cedex 9 31059
    France

    Site Not Available

  • Pharmacy

    Avenue Albert Raymond, Saint Priest en jarez 42270
    France

    Site Not Available

  • Pharmacy

    Tsa 50032, Toulouse 31059 Cedex 9
    France

    Site Not Available

  • Hopital Beaujon

    Clichy, 92110
    France

    Site Not Available

  • Hopital Beaujon

    Clichy Cedex, 92110
    France

    Site Not Available

  • CHRU de Lille, Pharamcie Centrale

    Lille, 59037
    France

    Site Not Available

  • CIC - Hopital Cardiologique

    Lille, 59037
    France

    Site Not Available

  • Hopital Huriez, CHRU de Lille

    Lille Cedex, 59037
    France

    Site Not Available

  • Hopital de l'Archet 2 - CHU de Nice

    NICE Cedex 3, 06202
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Hopital Nord

    St Priest En Jarez, 42270
    France

    Site Not Available

  • Institut Federatif de Biologie

    Tolouse, 31059 Cedex 9
    France

    Site Not Available

  • Hopital Rangueil

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • CHU de Toulouse-Hopital Rangueil

    Toulouse cedex 09, 31059
    France

    Site Not Available

  • Robert Bosch Krankenhaus GmbH

    Stuttgart, Baden-wuerttemberg 70376
    Germany

    Site Not Available

  • Universitaetsklinikum Ulm

    Ulm, Baden-wuerttemberg 89081
    Germany

    Site Not Available

  • "Charite - Campus Berlin Mitte Medizinische Klinik

    Berlin, 10117
    Germany

    Site Not Available

  • Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum

    Berlin, 13353
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120
    Germany

    Site Not Available

  • Krankenhaus Martha-Maria Halle-Doelau GmbH

    Halle (Saale), 06120
    Germany

    Site Not Available

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Universitaetsfrauenklinikum Schleswig-Holstein

    Luebeck, 23538
    Germany

    Site Not Available

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423
    Germany

    Site Not Available

  • Universitaetsklinik Regensburg

    Regensburg, 93042
    Germany

    Site Not Available

  • Pfizer Investigational Site

    Nagakute, Aichi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Nagoya, Aichi
    Japan

    Site Not Available

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, Aomori 036-8545
    Japan

    Site Not Available

  • National Hospital Organization Takasaki General Medical Center

    Takasaki, Gunma 370-0829
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama, Kanagawa 232-0024
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama-Shi, Kanagawa 232-0024
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • The Jikei University Hospital

    Minato-Ku, Tokyo 105-8471
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-Ku, Tokyo 160-8582
    Japan

    Site Not Available

  • National Hospital Organization Hirosaki National Hospital

    Aomori, Toyko 036-8545
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Kanagawa, 232-0024
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Guri-si, Gyeonggi-do 471-701
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Jongno-gu, Seoul 110-746
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, 602-739
    Korea, Republic of

    Site Not Available

  • Yeungnam University Hospital

    Daegu, 705-717
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul, 110-746
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • University Medical Center Groningen

    Groningen, 9713GZ
    Netherlands

    Site Not Available

  • Maastricht University Medical Center

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

  • Sykehusapoteket Asker og Baerum

    Gjettum, 1346
    Norway

    Site Not Available

  • Oslo Universitetssykehus

    Olso, 0424
    Norway

    Site Not Available

  • Lovisenberg Diakonale Sykehus

    Oslo, 0440
    Norway

    Site Not Available

  • Oslo Universitetssykehus

    Oslo, 0424
    Norway

    Site Not Available

  • Vestre Viken HF

    Rud, 1309
    Norway

    Site Not Available

  • Centrum Endoskopii Zabiegowej

    Bydgoszcz, 85-168
    Poland

    Site Not Available

  • Pfizer Investigational Site

    Bydgoszczy, 85-168
    Poland

    Site Not Available

  • NZOZ Centrum Medyczne Szpital Sw. Rodziny

    Lodz, 90-302
    Poland

    Site Not Available

  • Pfizer Investigational Site

    Lublin, 20-954
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie

    Warszawa, 02-507
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

    Warszawa, 02-507
    Poland

    Site Not Available

  • Lexmedica

    Wroclaw, 53-114
    Poland

    Site Not Available

  • Pfizer Investigational Site

    Coimbra, 3000-075
    Portugal

    Site Not Available

  • Clinical Hospital Centre Bezanijska Kosa

    Belgrade, 11080
    Serbia

    Site Not Available

  • Military Medical Academy

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology

    Zemun, 11080
    Serbia

    Site Not Available

  • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

    Bratislava, 831 04
    Slovakia

    Site Not Available

  • Medak s.r.o.

    Bratislava, 851 01
    Slovakia

    Site Not Available

  • KM Management spol. s r.o.

    Nitra, 949 01
    Slovakia

    Site Not Available

  • Synergy group, a.s.

    Nove Mesto nad Vahom, 915 01
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Trnava, 917 01
    Slovakia

    Site Not Available

  • Pfizer Investigational Site

    Overport, Durban 4091
    South Africa

    Site Not Available

  • Wits Clinical Research

    Johannesburg, Gauteng, South Africa 2193
    South Africa

    Site Not Available

  • Parklands Medical Centre

    Durban, KWA ZULU Natal 4091
    South Africa

    Site Not Available

  • eResearch Technology (ERT) Laboratory

    Philadelphia, PA 19103
    South Africa

    Site Not Available

  • Kingsbury Hospital

    Cape Town, Western CAPE 7708
    South Africa

    Site Not Available

  • Quintiles Laboratories South Africa

    Gauteng, 2193
    South Africa

    Site Not Available

  • Corporacio Sanitaria Parc Tauli de Sabadell

    Sabadell, Barcelona 08208
    Spain

    Site Not Available

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Pfizer Investigational Site

    Goteborg, 413 45
    Sweden

    Site Not Available

  • Pfizer Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • UCSD Medical Center - Thorton Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • Community Clinical Trials

    Orange, California 92868
    United States

    Site Not Available

  • GastroDiagnostics

    Orange, California 92868
    United States

    Site Not Available

  • Pfizer Investigational Site

    Redlands, California 92374
    United States

    Site Not Available

  • Pfizer Investigational Site

    Whittier, California 90603
    United States

    Site Not Available

  • Clinical Research of the Rockies

    Lafayette, Colorado 80026
    United States

    Site Not Available

  • Rmga - Rmcr

    Thornton, Colorado 80229
    United States

    Site Not Available

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado 80229
    United States

    Site Not Available

  • Pfizer Investigational Site

    Bridgeport, Connecticut 06606
    United States

    Site Not Available

  • Pfizer Investigational Site

    Bristol, Connecticut 06010
    United States

    Site Not Available

  • Pfizer Investigational Site

    Fairfield, Connecticut 06824
    United States

    Site Not Available

  • MGG Group Co., Inc.

    Washington, District of Columbia 20006
    United States

    Site Not Available

  • MGG Group Co., Inc.

    Washington, D.C., District of Columbia 20006
    United States

    Site Not Available

  • Shands Hospital at the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Shands Endoscopy Center

    Gainsville, Florida 32608
    United States

    Site Not Available

  • Pfizer Investigational Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Florida Center for Gastroenterology

    Largo, Florida 33777
    United States

    Site Not Available

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Crohn's and Colitis Center

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Hospital and Clinic

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami Hospital and Clinic (IP Shipment Only)

    Miami, Florida 33136
    United States

    Site Not Available

  • Citrus Ambulatory Surgery Center

    Orlando, Florida 32806
    United States

    Site Not Available

  • Internal Medicine Specialists

    Orlando, Florida 32806
    United States

    Site Not Available

  • Heartland Medical Research, Inc.

    Clive, Iowa 50325
    United States

    Site Not Available

  • Iowa Digestive Disease Center

    Clive, Iowa 50325
    United States

    Site Not Available

  • Iowa Endoscopy Center (Colonoscopy Only)

    Clive, Iowa 50325
    United States

    Site Not Available

  • Pfizer Investigational Site

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Chevy Chase Clinical Research/Metropolitan Gastroenterology Group

    Chevey Chase, Maryland 20815
    United States

    Site Not Available

  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • UMass Memorial Medical Center

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • University of Massachusetts Worcester

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Center for Digestive Health

    Troy, Michigan 48098
    United States

    Site Not Available

  • Surgical Centers of Michigan

    Troy, Michigan 48098
    United States

    Site Not Available

  • Pfizer Investigational Site

    Plymouth, Minnesota 55446
    United States

    Site Not Available

  • Pfizer Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Surgery Center of Columbia

    Columbia, Missouri 65201
    United States

    Site Not Available

  • Audrain Medical Center

    Mexico, Missouri 65265
    United States

    Site Not Available

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri 65265
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Barnes-Jewish Hospital - Investigational Drug Services

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Center for Advanced Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine - Division of Gastroenterology

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Pfizer Investigational Site

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Albany Medical College

    Albany, New York 12208
    United States

    Site Not Available

  • Pfizer Investigational Site

    Brooklyn, New York 11230
    United States

    Site Not Available

  • New York Hospital Queens

    Flushing, New York 11355
    United States

    Site Not Available

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York 11021
    United States

    Site Not Available

  • Nassau Gastroenterology Associates Office Based Surgery

    Great Neck, New York 11021
    United States

    Site Not Available

  • Nassau Gastroenterology Associates, P.C.

    Great Neck, New York 11021
    United States

    Site Not Available

  • North Shore Primary Care, P.C.

    Great Neck, New York 11021
    United States

    Site Not Available

  • Pfizer Investigational Site

    Manhasset, New York 11030
    United States

    Site Not Available

  • Lenox Hill Endoscopy Center

    New York, New York 10075
    United States

    Site Not Available

  • Synergy First

    New York, New York 11230
    United States

    Site Not Available

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York 12601
    United States

    Site Not Available

  • Pfizer Investigational Site

    Boone, North Carolina 28607
    United States

    Site Not Available

  • CTRC Hospital, UNC Memorial Hospital

    Chapel, North Carolina 27514
    United States

    Site Not Available

  • CTRC Hospital, UNC Memorial Hospital

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • North Carolina Memorial Hospital Endoscopy Center

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC Hospitals

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • UNC Hospitals Endoscopy

    Chapel Hill, North Carolina 27517
    United States

    Site Not Available

  • University Of North Carolina At Chapel Hill

    Chapell Hill, North Carolina 7080
    United States

    Site Not Available

  • Hillsborough Campus

    Hillsborough, North Carolina 27278
    United States

    Site Not Available

  • Pfizer Investigational Site

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • Pfizer Investigational Site

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Pfizer Investigational Site

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Pfizer Investigational Site

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Pfizer Investigational Site

    Pasadena, Texas 77505
    United States

    Site Not Available

  • Pfizer Investigational Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Pfizer Investigational Site

    Charlottesville, Virginia 22911
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin 53226
    United States

    Site Not Available

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