A Study To Monitor Long-Term Treatment With PF-00547659
- Registration Number
- NCT01298492
- Lead Sponsor
- Shire
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-Label Treatment PF-00547659 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
- Primary Outcome Measures
Name Time Method Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies 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.
Serum Trough Concentrations of PF-00547659 Versus Time 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.
Trial Locations
- Locations (110)
Albany Medical College
🇺🇸Albany, New York, United States
Nassau Gastroenterology Associates Office Based Surgery
🇺🇸Great Neck, New York, United States
Nassau Gastroenterology Associates, P.C.
🇺🇸Great Neck, New York, United States
North Shore Primary Care, P.C.
🇺🇸Great Neck, New York, United States
Kingsbury Hospital
🇿🇦Cape Town, Western CAPE, South Africa
Oshawa Clinic
🇨🇦Oshawa, Ontario, Canada
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier de Mouscron
🇧🇪Mouscron, Belgium
AKH Wien Universitaetsklinik fuer Innere Medizin III
🇦🇹Wien, Austria
Hopital de l'Archet 2 - CHU de Nice
🇫🇷NICE Cedex 3, France
Yokohama City University Medical Center
🇯🇵Yokohama-Shi, Kanagawa, Japan
Chiba University Hospital
🇯🇵Chiba, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
University of Miami Hospital
🇺🇸Miami, Florida, United States
Hopital Saint-Louis
🇫🇷Paris, France
Vestre Viken HF
🇳🇴Rud, Norway
Lovisenberg Diakonale Sykehus
🇳🇴Oslo, Norway
NZOZ Centrum Medyczne Szpital Sw. Rodziny
🇵🇱Lodz, Poland
Rocky Mountain Gastroenterology Associates
🇺🇸Thornton, Colorado, United States
Clinical Research of the Rockies
🇺🇸Lafayette, Colorado, United States
Rmga - Rmcr
🇺🇸Thornton, Colorado, United States
Hospital Erasme
🇧🇪Brussels, Belgium
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
UCSD Medical Center - Thorton Hospital
🇺🇸La Jolla, California, United States
Community Clinical Trials
🇺🇸Orange, California, United States
GastroDiagnostics
🇺🇸Orange, California, United States
MGG Group Co., Inc.
🇺🇸Washington, District of Columbia, United States
Florida Center for Gastroenterology
🇺🇸Largo, Florida, United States
University of Miami Crohn's and Colitis Center
🇺🇸Miami, Florida, United States
University of Miami Hospital and Clinic (IP Shipment Only)
🇺🇸Miami, Florida, United States
University of Miami Hospital and Clinic
🇺🇸Miami, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Citrus Ambulatory Surgery Center
🇺🇸Orlando, Florida, United States
Heartland Medical Research, Inc.
🇺🇸Clive, Iowa, United States
Iowa Endoscopy Center (Colonoscopy Only)
🇺🇸Clive, Iowa, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Massachusetts Worcester
🇺🇸Worcester, Massachusetts, United States
Center for Digestive and Liver Diseases, Inc.
🇺🇸Mexico, Missouri, United States
Barnes-Jewish Hospital - Investigational Drug Services
🇺🇸Saint Louis, Missouri, United States
Surgery Center of Columbia
🇺🇸Columbia, Missouri, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Surgical Centers of Michigan
🇺🇸Troy, Michigan, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
Audrain Medical Center
🇺🇸Mexico, Missouri, United States
Center for Advanced Medicine
🇺🇸Saint Louis, Missouri, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
New York Hospital Queens
🇺🇸Flushing, New York, United States
Lenox Hill Endoscopy Center
🇺🇸New York, New York, United States
Synergy First
🇺🇸New York, New York, United States
CTRC Hospital, UNC Memorial Hospital
🇺🇸Chapel Hill, North Carolina, United States
Premier Medical Group of the Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
UNC Hospitals Endoscopy
🇺🇸Chapel Hill, North Carolina, United States
UNC Hospitals
🇺🇸Chapel Hill, North Carolina, United States
North Carolina Memorial Hospital Endoscopy Center
🇺🇸Chapel Hill, North Carolina, United States
Hillsborough Campus
🇺🇸Hillsborough, North Carolina, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Allegiance Research Specialists
🇺🇸Wauwatosa, Wisconsin, United States
AKH Wien
🇦🇹Wien, Austria
Centre Hospitalier Universitaire De Liege-Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
UZ Gasthuisberg - Pharmacy
🇧🇪Leuven, Belgium
Toronto Digestive Disease Associates Inc.
🇨🇦Vaughan, Ontario, Canada
Hopital Huriez, CHRU de Lille
🇫🇷Lille Cedex, France
Hopital Beaujon
🇫🇷Clichy, France
CHRU de Lille, Pharamcie Centrale
🇫🇷Lille, France
CIC - Hopital Cardiologique
🇫🇷Lille, France
Hopital Nord
🇫🇷St Priest En Jarez, France
Charite, Universitaetsmedizin Berlin, Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Hopital Rangueil
🇫🇷Toulouse Cedex 9, France
Robert Bosch Krankenhaus GmbH
🇩🇪Stuttgart, Baden-wuerttemberg, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
🇩🇪Halle, Germany
Universitaetsfrauenklinikum Schleswig-Holstein
🇩🇪Luebeck, Germany
"Charite - Campus Berlin Mitte Medizinische Klinik
🇩🇪Berlin, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden-wuerttemberg, Germany
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Germany
Gastroenterologische Gemeinschaftspraxis Minden
🇩🇪Minden, Germany
Universitaetsklinik Regensburg
🇩🇪Regensburg, Germany
National Hospital Organization Takasaki General Medical Center
🇯🇵Takasaki, Gunma, Japan
The Jikei University Hospital
🇯🇵Minato-Ku, Tokyo, Japan
National Hospital Organization Hirosaki National Hospital
🇯🇵Aomori, Toyko, Japan
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Oslo Universitetssykehus
🇳🇴Oslo, Norway
Sykehusapoteket Asker og Baerum
🇳🇴Gjettum, Norway
Centrum Endoskopii Zabiegowej
🇵🇱Bydgoszcz, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
🇵🇱Warszawa, Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych W Warszawie
🇵🇱Warszawa, Poland
Lexmedica
🇵🇱Wroclaw, Poland
Military Medical Academy
🇷🇸Belgrade, Serbia
Clinical Hospital Centre Bezanijska Kosa
🇷🇸Belgrade, Serbia
Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.
🇸🇰Bratislava, Slovakia
Medak s.r.o.
🇸🇰Bratislava, Slovakia
Clinical Hospital Center Zemun, Clinical Department for Gastroenterology and Hepatology
🇷🇸Zemun, Serbia
KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
Synergy group, a.s.
🇸🇰Nove Mesto nad Vahom, Slovakia
Parklands Medical Centre
🇿🇦Durban, KWA ZULU Natal, South Africa
Wits Clinical Research
🇿🇦Johannesburg, Gauteng, South Africa, South Africa
Hospital Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Corporacio Sanitaria Parc Tauli de Sabadell
🇪🇸Sabadell, Cataluna, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain