A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
NCT ID: NCT01620255
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
357 participants
INTERVENTIONAL
2012-11-02
2016-02-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
Drug Dose Level 1
PF-00547659 SC Injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
Drug Dose Level 2
PF-00547659 SC Injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
Drug Dose Level 3
PF-00547659 SC Injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
Drug Dose Level 4
PF-00547659 SC Injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Interventions
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Placebo
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
PF-00547659 SC Injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
PF-00547659 SC Injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
PF-00547659 SC Injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
PF-00547659 SC Injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Ulcerative colitis must be active beyond the rectum.
* Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points
Exclusion Criteria
* Diagnosis of indeterminate colitis or Crohn's Disease
* Subjects with history of colonic or small bowel obstruction or resection.
18 Years
65 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Office of Drs. Ranjit Andrew Singh and Jamie D. Papp
Victoria, British Columbia, Canada
PerCuro Clinical Research Limited
Victoria, British Columbia, Canada
Mayo Clinic Arizona
Scottsdale, Arizona, United States
UCSD Health System-Pharmacy only
La Jolla, California, United States
Clinical and Translational Research Institute
La Jolla, California, United States
Perlman Medical Offices
La Jolla, California, United States
Thornton Hospital
La Jolla, California, United States
Community Clinical Trials
Orange, California, United States
GastroDiagnostics - Community Clinical Trials Drug
Orange, California, United States
Rocky Mountain Clinical Research, LLC.
Denver, Colorado, United States
Clinical Research of the Rockies
Lafayette, Colorado, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, United States
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, United States
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, United States
Medical REsearch Center of CT Drug
Hamden, Connecticut, United States
Medical Research Network of Connecticut
Hamden, Connecticut, United States
Florida Surgery Center
Altamonte Springs, Florida, United States
Gastroenterology Associates
Crystal River, Florida, United States
Research Consultant Group
Hialeah, Florida, United States
Th Palmetto Surgery Center
Hialeah, Florida, United States
Citrus Memorial Hospital
Inverness, Florida, United States
Inverness Medical Imaging
Inverness, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Suncoast Endoscopy Center
Inverness, Florida, United States
Sand Lake Imaging
Maitland, Florida, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
University of Miami Hospital and Clinic - Local Lab
Miami, Florida, United States
University of Miami Hospital and Clinic
Miami, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Coral View Surgery Center
Miami, Florida, United States
Center for Diagnostic Imaging
Miami Beach, Florida, United States
First Quality Laboratory
Miramar, Florida, United States
FQL Research, LLC
Miramar, Florida, United States
Venutre Ambulatory Sugery Center
North Miami Beach, Florida, United States
Boston Diagnostic Imaging
Orlando, Florida, United States
Citrus Ambulatory Surgery Center
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Georgia Endoscopy Center
Alpharetta, Georgia, United States
GI Consultants
Atlanta, Georgia, United States
Atlanta Gastroenterology Specialist
Suwanee, Georgia, United States
Covance Central Laboratory Services Inc
Indianapolis, Indiana, United States
Covance Central Laboratory Services, Inc
Indianapolis, Indiana, United States
Covance Laboratory Services, Inc
Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Endoscopic Microsurgery Associates
Towson, Maryland, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
Signature Healthcare Brockton
Brockton, Massachusetts, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
East Valley Endoscopy
Grand Rapids, Michigan, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, United States
Metro Health Endoscopy Unit
Wyoming, Michigan, United States
Minneapolis Medical Eye Clinic
Minneapolis, Minnesota, United States
Noran Neurology Clinic
Minneapolis, Minnesota, United States
Minneapolis Heart Institute
Plymouth, Minnesota, United States
Consulting Radiology
Plymouth, Minnesota, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Surgery Center of Columbia
Columbia, Missouri, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, United States
Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)
St Louis, Missouri, United States
Barnes-Jewish Hospital Radiology (X-Ray Only)
St Louis, Missouri, United States
Center for Advanced Medicine
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nevada School of Medicine (UNSOM)
Las Vegas, Nevada, United States
Las Vegas Surgery Center
Las Vegas, Nevada, United States
Steinberg Diagnostic Medical Imaging Centers
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
New York Presbyterian Hospital - Weill Cornell Medical College
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, United States
Weill Cornell Medical College of Cornell University
New York, New York, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States
Premier Medical Group Research Department - Drug
Poughkeepsie, New York, United States
UNC Hospitals Endoscopy Center At Meadowmont
Chapel Hill, North Carolina, United States
Department of Pharmacy Investigational Drug Services
Chapel Hill, North Carolina, United States
UNC Memorial Hospital
Chapel Hill, North Carolina, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
The Oregon Clinic, PC - Gastroenterology West
Portland, Oregon, United States
Gastro One
Germantown, Tennessee, United States
Diagnostic Imaging
Memphis, Tennessee, United States
Vanderbilt University Medical Center: GI Clinical Research
Nashville, Tennessee, United States
Vanderbilt University Medical Center: IBD Clinic
Nashville, Tennessee, United States
Vanderbilt University Medical Center: Drug Shipment
Nashville, Tennessee, United States
Vanderbilt University Medical Center: Endoscopy Lab
Nashville, Tennessee, United States
Vanderbilt University Medical Center: Outpatient Radiology
Nashville, Tennessee, United States
Houston Hospital for Specialized Surgery
Houston, Texas, United States
Baylor Clinic (Drug Storage)
Houston, Texas, United States
Baylor College Of Medicine - Baylor Medical Center
Houston, Texas, United States
Spring Gastroenterology and Associates
Humble, Texas, United States
Spring Gastroenterology Drug
Humble, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Pioneer Research Solutions, Inc
Sugar Land, Texas, United States
McGuire DVAMC
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
PI Radiology
Milwaukee, Wisconsin, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
Dynacare Laboratories
Wauwatosa, Wisconsin, United States
GI associates drug
Wauwatosa, Wisconsin, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Mater Health Services
South Brisbane, Queensland, Australia
Alfred Hospital
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
The Canberra Hospital
Garran, , Australia
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Vienna, , Austria
AZ St-Elisabeth Herentals
Herentals, , Belgium
University Hospital Gasthuisberg
Leuven, , Belgium
Centre Hospitalier de Mouscron
Mouscron, , Belgium
4- MBAL
Sofia, , Bulgaria
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
Sofia, , Bulgaria
MBAL SofiaMed OOD
Sofia, , Bulgaria
GI Research Institute (GIRI)
Vancouver, British Columbia, Canada
Office of Dr. David C. Pearson
Victoria, British Columbia, Canada
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, Ontario, Canada
McMaster University Medical Center
Hamilton, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Oshawa Clinic
Oshawa, Ontario, Canada
Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Hepato-Gastroenterology HK s.r.o.
Hradec Králové, , Czechia
Klinické Centrum ISCARE I.V.F
Prague, , Czechia
Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.
Ústí nad Labem, , Czechia
CHU Amiens - Hôpital Nord
Amiens, , France
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
Caen, , France
Hopital Huriez CHRU de Lille
Lille, , France
Hôpital l'Archet 2 CHU de Nice
Nice, , France
Hopital Haut Leveque
Pessac, , France
Hôpital Nord Service de Gastro-entérologie
Saint-Priest-en-Jarez, , France
CHU Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, , Germany
Universitaetsklinik Regensburg
Regensburg, , Germany
Robert-Bosch-Krankenhaus GmbH
Stuttgart, , Germany
Pannonia Maganorvosi Centrum Kft
Budapest, , Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, , Hungary
Digestive Disease Institute
Jerusalem, , Israel
Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital
Jerusalem, , Israel
Dept. of Gastroenterology & Hepatology, Meir Medical Center
Kfar Saba, , Israel
Gastroenterology Division, Rabin Medical Center, Beilinson Campus
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva
Catanzaro, , Italy
IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS
Milan, , Italy
IRCCS Policlinico San Donato
Milan, , Italy
Azienda Ospedaliera -Università di Padova
Padua, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
Roma, , Italy
Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"
Roma, , Italy
AOS San Camillo Forlanini
Rome, , Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Academic Medical Center - University of Amsterdam
Amsterdam, North Holland, Netherlands
University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Christchurch Hospital
Christchurch, , New Zealand
Southern Endoscopy Centre
Christchurch, , New Zealand
Midland Neurology & EMG Ltd.
Hamilton, , New Zealand
The Hamilton Eye Clinic
Hamilton, , New Zealand
Cardiac Services Ltd.
Hamilton, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
Bydgoszcz, , Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, , Poland
Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.
Lodz, , Poland
Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa
Poznan, , Poland
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem
Warsaw, , Poland
NZOZ Vivamed
Warsaw, , Poland
Wojskowy Szpital Kliniczny z Poliklinika SPOZ
Wroclaw, , Poland
Lexmedica
Wroclaw, , Poland
SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "
Saint Petersburg, , Russia
Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine
Belgrade, , Serbia
Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology
Belgrade, , Serbia
Military medical Academy
Belgrade, , Serbia
Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department
Belgrade, , Serbia
Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
Niš, , Serbia
Gastro I., s.r.o.
Prešov, Slovak Republic, Slovakia
Gastroenterological Centre Thalion
Bratislava, , Slovakia
KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra
Nitra, , Slovakia
Ustredna vojenska nemocnice SNP Ruzomberok
Ružomberok, , Slovakia
Kingsbury Hospital
Claremont, CAPE TOWN, South Africa
Pusan National University Hospital
Busan, , South Korea
Yeungnam University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Yonsei University College of Medicine, Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Parc de Salut Mar-Hospital del Mar
Barcelona, , Spain
Centro Medico Teknon
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Countries
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References
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Zhou H, Xi L, Ziemek D, O'Neil S, Lee J, Stewart Z, Zhan Y, Zhao S, Zhang Y, Page K, Huang A, Maciejewski M, Zhang B, Gorelick KJ, Fitz L, Pradhan V, Cataldi F, Vincent M, Von Schack D, Hung K, Hassan-Zahraee M. Molecular Profiling of Ulcerative Colitis Subjects from the TURANDOT Trial Reveals Novel Pharmacodynamic/Efficacy Biomarkers. J Crohns Colitis. 2019 May 27;13(6):702-713. doi: 10.1093/ecco-jcc/jjy217.
Vermeire S, Sandborn WJ, Danese S, Hebuterne X, Salzberg BA, Klopocka M, Tarabar D, Vanasek T, Gregus M, Hellstern PA, Kim JS, Sparrow MP, Gorelick KJ, Hinz M, Ahmad A, Pradhan V, Hassan-Zahraee M, Clare R, Cataldi F, Reinisch W. Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jul 8;390(10090):135-144. doi: 10.1016/S0140-6736(17)30930-3. Epub 2017 May 17.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2012-002030-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TURANDOT
Identifier Type: OTHER
Identifier Source: secondary_id
A7281009
Identifier Type: -
Identifier Source: org_study_id
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