Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
330 participants
INTERVENTIONAL
2013-03-18
2017-12-13
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
NONE
Study Groups
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SHP647 75 mg
Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.
SHP647 225 mg
Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
225mg SHP647 (PF-00547659)
225 mg sterile liquid injected subcutaneously every 4 weeks.
Interventions
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75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.
225mg SHP647 (PF-00547659)
225 mg sterile liquid injected subcutaneously every 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.
Exclusion Criteria
* Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
18 Years
66 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Shire Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Mayo Clinic Arizona - Scottsdale
Scottsdale, Arizona, United States
UCSD Altman Clinical and Translational Research Institute
La Jolla, California, United States
Community Clinical Trials
Orange, California, United States
Rocky Mountain Gastroenterology
Thornton, Colorado, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Bassan and Bloom M.D.s
Miramar, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Minnesota Gastroenterology, PA
Plymouth, Minnesota, United States
Center for Digestive and Liver Diseases
Mexico, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, 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
UNC Memorial Hospital
Chapel Hill, North Carolina, United States
The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
Portland, Oregon, United States
Gastro One
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College Of Medicine - Baylor Medical Center
Houston, Texas, United States
McGuire DVAMC
Richmond, Virginia, United States
Univeristy of Washington
Seattle, Washington, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
The Canberra Hospital
Garran, Australian Capital Territory, Australia
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
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
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
Sofia, , Bulgaria
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada
Percuro Clinical Research, Ltd
Victoria, British Columbia, Canada
Hamilton Health Sciences Corp, McMaster Univ Medical Centre
Hamilton, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Taunton Surgical Centre
Oshawa, Ontario, Canada
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Hepato-Gastroenterologie HK s.r.o. Poliklinika III
Hradec Králové, , Czechia
IBD Clinical and Research Centre
Prague, , Czechia
Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem
Ústí nad Labem, , Czechia
CHU Amiens-Picardie - Hopital Sud
Amiens, , France
Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
Caen, , France
Hopital Huriez CHRU de Lille
Lille, , France
CHU De Nice Hopital De L'Archet II
Nice, , France
CHU de Saint-Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
CHU de Nancy - Hopital Brabois
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
Regensburg, , Germany
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes, Csongrád megye, Hungary
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Universita' degli Studi "Magna Graecia" di Catanzaro
Catanzaro, , Italy
Milan University, Humanitas Clinical Institute
Milan, , Italy
Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
Roma, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Universita Cattolica del Sacro Cuore
Roma, , Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Academic Medical Center
Amsterdam, , Netherlands
University Medical Center Groningen (UMCG)
Groningen, , Netherlands
Maastricht University Medical Center
Maastricht, , Netherlands
Christchurch Hospital
Christchurch, Canterbury, New Zealand
Waikato Hospital
Hamilton, , New Zealand
Centrum Endoskopii Zabiegowej
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
Lodz, Wojlodzkie, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, , Poland
NZOZ Centrum Medyczne HCP sp. z o.o
Poznan, , Poland
Klinika Chorob Wewnetrznych I Gastroenterologii
Warsaw, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
Warsaw, , Poland
Lexmedica
Wroclaw, , Poland
St. Petersburg State Medical Academy for Postgraduate Education
Saint Petersburg, , Russia
Military Medical Academy
Belgrade, , Serbia
Clinical Hospital Center Zemun
Belgrade, , Serbia
Clinical Hospital Centre Bezanijska Kosa
Belgrade, , Serbia
Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
Nitra, , Slovakia
Gastro L., s.r.o.
Prešov, , Slovakia
Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
Ružomberok, , Slovakia
Kingsbury Hospital
Claremont, Cape Town, South Africa
Yeungnam University Medical Center
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Centro Medico Teknon-Institut de la Macula i de la Retina
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Parc de Salut Mar-Hospital del Mar
Barcelona, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2012-002031-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TURANDOT II
Identifier Type: OTHER
Identifier Source: secondary_id
A7281010
Identifier Type: -
Identifier Source: org_study_id
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