A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
NCT ID: NCT01393626
Last Updated: 2017-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
280 participants
INTERVENTIONAL
2011-10-31
2015-03-31
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 BID
Placebo
oral tablets twice daily
5mg BID
CP-690,550
oral tablets twice daily
10mg BID
CP-690,550
oral tablets twice daily
Interventions
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Placebo
oral tablets twice daily
CP-690,550
oral tablets twice daily
CP-690,550
oral tablets twice daily
Eligibility Criteria
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Inclusion Criteria
* Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
* Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.
Exclusion Criteria
* Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
* Subjects receiving the following treatment for Crohn's disease:
* Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
* Anti-TNFα therapy within 8 weeks prior to baseline.
* Interferon therapy within 8 weeks prior to baseline.
* Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
* Intravenous corticosteroids within 2 weeks prior to baseline.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Clinical Research Institute of Michigan LLC
Chesterfield, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Charlotte Radiology (Chest X-Ray Only)
Charlotte, North Carolina, United States
University Hospitals Chagrin Highlands Health Center
Beachwood, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Dayton Gastroenterology, Inc.
Dayton, Ohio, United States
Great Lakes Gastroenterology
Mentor, Ohio, United States
The Endoscopy Center of Lake County
Mentor, Ohio, United States
University Hospitals Westlake Medical Center
Westlake, Ohio, United States
Great Lakes Gastroenterology
Willoughby, Ohio, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
UT Health Science Center
Houston, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Cardiology Consultants (ECG Site Only)
Norfolk, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
MRI & CT Diagnostics
Virginia Beach, Virginia, United States
The Center for Digestive Health
Milwaukee, Wisconsin, United States
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Medical Diagnostic Imaging (MDI) X-ray and MRI only
Milwaukee, Wisconsin, United States
Allegiance Research Specialists
Wauwatosa, Wisconsin, United States
GI Associates
Wauwatosa, Wisconsin, United States
Nepean Public Hospital
Kingswood, New South Wales, Australia
Monash Medical Center
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
AKH Wien Universitaetsklinik fuer Innere Medizin III
Vienna, , Austria
4-MBAL, Parvo vatreshno otdelenie
Sofia, , Bulgaria
MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
Sofia, , Bulgaria
MBAL Voennomeditsinska Akademia
Sofia, , Bulgaria
MBAL Sofiamed OOD, Otdelenie po gastroenterologia
Sofia, , Bulgaria
University of Calgary
Calgary, Alberta, Canada
Office of Dr. David C. Pearson
Victoria, British Columbia, Canada
Office of Drs. Ranjith Andrew Singh and Jamie D. Papp
Victoria, British Columbia, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada
Inflammatory Bowel Disease Centre, Montreal General Hospital, McGill University Health Centre
Montreal, Quebec, Canada
University Hospital Centre Rijeka
Rijeka, , Croatia
University Hospital Center Zagreb
Zagreb, , Croatia
Medial Pharma spol.s.r.o.
Hradec Králové, , Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
RDG centrum s.r.o.
Hradec Králové, , Czechia
Hopital Huriez, CHRU de Lille
Lille, , France
Hopital Haut-Leveque
Pessac, , France
Hopital Robert Debre
Reims, , France
Charite - Campus Berlin Mitte
Berlin, , Germany
Charite Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Gastroenterologische Gemeinschaftspraxis Minden
Minden, , Germany
Universitaetsklinikum Ulm, Klinik fuer Innere Medizin I
Ulm, , Germany
General Hospital of Athens "Evangelismos",1st Gastroenterology Department
Kolonaki Athens, , Greece
Magyar Honvedseg Honvedkorhaz II. telephely/Gasztroenterologiai Osztaly
Budapest, , Hungary
Peterfy Sandor Utcai Korhaz, Rendelointezet es Baleseti Kozpont, I. sz. Belgyogyaszat
Budapest, , Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak/I. Belgyogyaszat es Gastroenterologia
Budapest, , Hungary
Pannonia Maganorvosi Centrum Kft
Budapest, , Hungary
Laboratorium Kft. Fovarosi es Pest Megyei Mikrobiologiai Laboratorium
Budapest, , Hungary
Bugat Pal Korhaz Egeszsegugyi Szolgaltato Kozhasznu Nonprofit Kft
Gyöngyös, , Hungary
Somogy megyei Kaposi Mor Oktato Korhaz / Belgyogyaszati osztaly
Kaposvár, , Hungary
Clinfan Kft.
Szekszárd, , Hungary
Digestive Diseases Institute, Shaare Zedek Medical Center
Jerusalem, , Israel
Dept. of Gastroenterology & Hepatology, Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyo-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Toho University Sakura Medical Center
Chiba, , Japan
VU University Medical Center
Amsterdam, , Netherlands
Academisch Medisch Centrum
Amsterdam, , Netherlands
Kingsbury Hospital
Cape Town, Western Cape, South Africa
Parklands Medical Centre
Durban, , South Africa
Severance Hospital, Yeonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
ASAN Medical Center
Seoul, , South Korea
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
State Institution "Institute of Gastroenterology of AMS of Ukraine"
Dnipropetrovsk, , Ukraine
Donetsk National Medical University n.a M. Gorky, Faculty of Internal Medicine #2,
Donetsk, , Ukraine
State Institution "Institute of Therapy n.a. L.T. Mala of AMS of Ukraine"
Kharkiv, , Ukraine
Lviv National Medical University n.a Danylo Halytsky, Faculty of Surgery#1 with Proctology Course
Lviv, , Ukraine
Municipal Institution "Odesa Regional Clinical Hospital". Odesa Regional Centre of Gastroenterology.
Odesa, , Ukraine
Medical Clinical Research Center Health Clinic on base LLC "Medical Diagnostic Center Slaomed"
Vinnitsa, , Ukraine
ACRI - Phase 1, LLC
Anaheim, California, United States
Advanced Clinical Research Institute - Phase 1, LLC
Anaheim, California, United States
AGMG Endoscopy Center
Anaheim, California, United States
Alliance Clinical Research
Oceanside, California, United States
Alliance Clinical Research, LLC
Poway, California, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States
Clinical Research Of The Rockies
Lafayette, Colorado, United States
Endoscopy Center of the Rockies - Longmont
Longmont, 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 Connecticut, LLC
Hamden, Connecticut, United States
Metropolitan Gastroenterology Group, PC
Washington D.C., District of Columbia, United States
Gasteroenterology Consultants of Clearwater
Clearwater, Florida, United States
West Coast Endoscopy Center
Clearwater, Florida, United States
Clinical Research of West Florida, Inc
Clearwater, Florida, United States
Citrus Surgery & Endoscopy Center (Colonoscopy & Biopsy Only)
Crystal River, Florida, United States
Shands Endoscopy Center
Gainesville, Florida, United States
Shands Hospital at the University of Florida
Gainesville, Florida, United States
Investigational Drug Service
Gainesville, Florida, United States
Shands Medical Plaza and Cancer Center
Gainesville, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Suncoast Endoscopy Center (Colonoscopy Only)
Inverness, Florida, United States
FQL Research, LLC
Miramar, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida, United States
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Heartland Medical Research, Inc (Administrative Only)
Clive, Iowa, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
Iowa Endoscopy Center (Colonoscopy Only)
Clive, Iowa, United States
Iowa Radiology (MRI, X-Ray Only)
Clive, Iowa, United States
Cotton-O'Neil Clinical (X-Ray)
Topeka, Kansas, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States
Stormont-Vail MRI Center of Kansas
Topeka, Kansas, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States
Metropolitan Gastroenterology Group, PC
Chevy Chase, Maryland, United States
East Ann Arbor Health and Geriatrics Center
Ann Arbor, Michigan, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Countries
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References
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Panes J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.
Related Links
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Other Identifiers
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2011-001733-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921083
Identifier Type: -
Identifier Source: org_study_id
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