A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
- Registration Number
- NCT01465763
- Lead Sponsor
- Pfizer
- Brief Summary
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 614
-
Subject must be at least 18 years of age.
-
Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
-
Subjects with moderately to severely active UC based on Mayo score criteria.
-
Subjects must have failed or be intolerant of at least one of the following treatments for UC:
- Corticosteroids (oral or intravenous).
- Azathioprine or 6 mercaptopurine (6 MP).
- Anti TNF-alpha therapy.
- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
- Subjects with disease limited to distal 15 cm.
- Subjects without previous treatment for UC (ie, treatment naïve).
- Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - tofacitinib 10 mg BID tofacitinib -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Remission at Week 8 Week 8 Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Mucosal Healing at Week 8 Week 8 Mucosal healing in participants was defined by Mayo endoscopic subscore of 0 or 1. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Percentage of Participants Achieving Clinical Response at Week 8 Week 8 Clinical response in participants was defined by a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Percentage of Participants With Endoscopic Remission at Week 8 Week 8 Endoscopic remission in participants was defined by Mayo endoscopic subscore of 0. The Mayo endoscopic subscore consisted of the findings of centrally read flexible proctosigmoidoscopy, graded from 0 to 3 with higher scores indicating more severe disease.
Percentage of Participants With Clinical Remission at Week 8 Week 8 Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Percentage of Participants With Symptomatic Remission at Week 8 Week 8 Symptomatic remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and 0 subscore for both rectal bleeding and stool frequency. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Percentage of Participants With Deep Remission at Week 8 Week 8 Deep remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and 0 subscore for both rectal bleeding and endoscopic subscores. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Partial Mayo Scores Baseline, Weeks 2, 4, 8 A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.
Change From Baseline in Partial Mayo Scores at Weeks 2, 4 and 8 Baseline, Weeks 2, 4, 8 Change in partial mayo scores at weeks 2, 4, 8 relative to baseline were reported. A Partial Mayo Score (mayo score without endoscopy) graded from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each grading from 0 to 3 with higher scores indicating more severe disease.
Change From Baseline in Total Mayo Scores at Week 8 Baseline, Week 8 Change in total Mayo scores at Week 8 relative to Baseline was reported. Mayo score is an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease.
Trial Locations
- Locations (177)
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Icahn School of Medicine at Mount Sinai
🇺🇸Marietta, Georgia, United States
GI Consultants (Colonoscopy only)
🇺🇸Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
NYU Langone Nassau Gastroenterology Associates
🇺🇸Great Neck, New York, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Baylor College of Medicine (Baylor Medical Center)
🇺🇸Houston, Texas, United States
Endocare Research Centre
🇿🇦Cape Town, Western Cape, South Africa
Springhill Memorial Hospital
🇺🇸Mobile, Alabama, United States
Cedars Sinai Medical Center - Thalians Bldg
🇺🇸Los Angeles, California, United States
Desert Advanced Imaging
🇺🇸Palm Springs, California, United States
Sharp Rees-Stealy Medical Group, Inc.
🇺🇸San Diego, California, United States
UCSD Medical Centre
🇺🇸La Jolla, California, United States
Hope Square Surgical Center
🇺🇸Rancho Mirage, California, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
Cedars Sinai Surgery Center
🇺🇸Los Angeles, California, United States
Internal Medicine Center, LLC
🇺🇸Mobile, Alabama, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
🇺🇸Los Angeles, California, United States
UCSD Medical Center
🇺🇸La Jolla, California, United States
Investigational Drug Service Pharmacy
🇺🇸La Jolla, California, United States
Citrus Ambulatory Surgery Center
🇺🇸Orlando, Florida, United States
A.O.R. Villa Sofia- Cervello
🇮🇹Palermo, PA, Italy
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Hopital Rangueil
🇫🇷Toulouse Cedex 9, France
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States
Hopital Saint-Louis
🇫🇷Paris, France
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
🇩🇪Berlin, Germany
Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
🇭🇺Budapest, Hungary
X-Ray Department of West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Rabin Medical Center, Beilinson campus
🇮🇱Petah Tikva, Israel
Baylor College of Medicine - Baylor Medical Center (Drug Storage)
🇺🇸Houston, Texas, United States
ECG Unit of West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Pecsi Tudomanyegyetem Klinikai Kozpont
🇭🇺Pecs, Hungary
CHU de Nantes - Hotel Dieu
🇫🇷Nantes, France
Klinikum Luneburg/Abteilung Gastroenterologie
🇩🇪Lüneburg, Germany
Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
🇭🇺Vac, Hungary
General Hospital Zadar
🇭🇷Zadar, Croatia
West Tallinn Central Hospital Internal Diseases Clinic
🇪🇪Tallinn, Estonia
Gabinet Lekarski - Janusz Rudzinski
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Chiba University Hospital
🇯🇵Chiba-shi, Chiba, Japan
McMaster University Medical Center
🇨🇦Hamilton, Ontario, Canada
Sameshima Hospital
🇯🇵Kagoshima, Japan
Universitaetsklinikum Halle (Saale)
🇩🇪Halle, Germany
AOU Mater Domini - U.O. Fisiopatologia Digestiva
🇮🇹Catanzaro, CZ, Italy
Istituto Clinico Humanitas IRCSS
🇮🇹Rozzano, Milano, Italy
Tokai University Hachioji Hospital
🇯🇵Hachioji, Tokyo, Japan
SOC Gastroenterologia Centro di Riferimento Oncologico
🇮🇹Aviano, Italy
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
IBD Center - IRCCS Humanitas
🇮🇹Milan, Italy
Shiga University of Medical Science Hospital
🇯🇵Otsu-shi, Shiga, Japan
Tokyo Medical And Dental University Hospital, Faculty of Medicine
🇯🇵Tokyo, Japan
Comitato Etico Palermo 2
🇮🇹Palermo, PA, Italy
State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
Leiden University Medical Center
🇳🇱Leiden, ZH, Netherlands
X-Ray Department, Clinic "Linezers"
🇱🇻Riga, Latvia
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
🇵🇱Lodz, Poland
Fukuoka University Chikushi Hospital
🇯🇵Fukuoka, Japan
State Budget Educational Institution of Higher Professional Education
🇷🇺Novosibirsk, Russian Federation
National Hospital Organization Hirosaki National Hospital
🇯🇵Hirosaki, Aomori, Japan
Samara Diagnostic center, X-ray Department
🇷🇺Samara, Russian Federation
GUZ City Hospital #26
🇷🇺Saint-Petersburg, Russian Federation
ECG room, Clinic "Linezers"
🇱🇻Riga, Latvia
Clinical Hospital Centre Zvezdara
🇷🇸Belgrade, Serbia
Medak s.r.o.
🇸🇰Bratislava, Slovakia
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
🇵🇱Warszawa, Mazowieckie, Poland
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
🇺🇦Lviv, Ukraine
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
🇯🇵Sapporo, Hokkaido, Japan
GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
🇷🇺Saint-Petersburg, Russian Federation
Military Medical Academy
🇷🇸Belgrade, Serbia
Chris Hani Baragwanath Academic Hospital
🇿🇦Johannesburg, Gauteng, South Africa
Clinical Centre of Kragujevac
🇷🇸Kragujevac, Serbia
LTD "St. Paraskeva Medical Center"
🇺🇦Lviv, Ukraine
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
🇺🇦Odesa, Ukraine
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
🇺🇦Uzhgorod, Ukraine
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Hospital Universitario de Fuenlabrada
🇪🇸Madrid, Spain
Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Limited Liability Company Medical Company "Hepatolog"
🇷🇺Samara, Russian Federation
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
🇺🇦Simferopol, Ar Krym, Ukraine
Cambridge University Hospitals Nhs Foundation Trust
🇬🇧Cambridge, United Kingdom
Kyiv Municipal Clinical Hospital #18, Proctology Department
🇺🇦Kyiv, Ukraine
Vinnytsia National Medical University
🇺🇦Vinnytsia, Ukraine
Toho University Sakura Medical Center
🇯🇵Sakura, Chiba, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki-shi, Osaka, Japan
National Hospital Organization Sendai Medical Center
🇯🇵Sendai, Miyagi, Japan
Osaka City University Hospital
🇯🇵Osaka, Japan
Keio University Hospital
🇯🇵Tokyo, Japan
Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
🇷🇺Samara, Russian Federation
Federal State Budgetary Military Educational Institution of High Professional Education
🇷🇺St. Petersburg, Russian Federation
Hospital Clínic i provincial de Barcelona
🇪🇸Barcelona, Spain
Kornbluth, Legnani, George MD, PC
🇺🇸New York, New York, United States
Bop Clinical School Clinical Trials Unit
🇳🇿Tauranga, New Zealand
Hertiage Medical Research Clinic- University Of Calgary
🇨🇦Calgary, Alberta, Canada
Hiroshima University Hospital
🇯🇵Hiroshima, Japan
Erik Palmer, DO
🇺🇸Palm Springs, California, United States
Homan A Zadeh, MD, MPH
🇺🇸Palm Springs, California, United States
Sharp Rees-Stealy Medical Group,Inc
🇺🇸San Diego, California, United States
Endoscopy Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Gastroenterology Center of Connecticut, PC
🇺🇸Hamden, Connecticut, United States
Florida Surgery Center
🇺🇸Altamonte Springs, Florida, United States
Medical Research Center of Connecticut, LLC
🇺🇸Hamden, Connecticut, United States
Center for Advanced Gastroenterology
🇺🇸Maitland, Florida, United States
MNH Surgical Center
🇺🇸Maitland, Florida, United States
North Florida Gastroenterology Research, LLC
🇺🇸Orange Park, Florida, United States
Orange Park Surgery Center
🇺🇸Orange Park, Florida, United States
Internal Medicine Specialists
🇺🇸Orlando, Florida, United States
Sand Lake Imaging
🇺🇸Maitland, Florida, United States
Georgia Endoscopy Center (Colonoscopy only)
🇺🇸Alpharetta, Georgia, United States
Florida Medical Clinic, P.A.
🇺🇸Zephyrhills, Florida, United States
Emory Healthcare Heart Center (EKG)
🇺🇸Johns Creek, Georgia, United States
Atlanta Gastroenterology Specialists, PC
🇺🇸Suwanee, Georgia, United States
Johns Creek Diagnostic Center (X-Ray only)
🇺🇸Suwanee, Georgia, United States
Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
🇺🇸Ann Arbor, Michigan, United States
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
Michigan Clinical Research Unit - Univeristy of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Medical Science Research Building 1 - University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
University of Michigan Health Systems
🇺🇸Ann Arbor, Michigan, United States
Huron Gastroenterology Associates / Center for Digestive Care
🇺🇸Ypsilanti, Michigan, United States
Center for Advanced Medicine
🇺🇸Saint Louis, Missouri, United States
Michigan Heart SJMH (Blood draws and ECGs only)
🇺🇸Ypsilanti, Michigan, United States
The Private Practice of Simon Lichtiger, MD
🇺🇸New York, New York, United States
Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
🇺🇸Ypsilanti, Michigan, United States
Mount Sinai Doctos Faculty Practice
🇺🇸New York, New York, United States
Washington University School of Medicine - Division of Gastroenterology
🇺🇸Saint Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
The Endoscopy Center of Lake County
🇺🇸Mentor, Ohio, United States
CUMC Research Pharmacy
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Houston Hospital for Specialized Surgery
🇺🇸Houston, Texas, United States
Mentor Medical Campus
🇺🇸Mentor, Ohio, United States
Gastroenterology Consultants, P.A.
🇺🇸Houston, Texas, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
Alpine Medical Group
🇺🇸Salt Lake City, Utah, United States
Wasatch Endoscopy Center
🇺🇸Salt Lake City, Utah, United States
Wisconsin Center for Advanced Research - GI Associates, LLC
🇺🇸Milwaukee, Wisconsin, United States
RGL Medical Services (x-ray only)
🇺🇸West Jordan, Utah, United States
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
🇧🇪Leuven, Belgium
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Eastern Health Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Hamilton Health Sciences Corporation - McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
AKH Wien, Universitaetsklinik fuer Innere Medizin III,
🇦🇹Wien, Austria
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
🇨🇴Barranquilla, Atlantico, Colombia
Institut klinicke a experimentalni mediciny
🇨🇿Praha 4, Czech Republic
Aarhus University Hospital
🇩🇰Aarhus C, Denmark
Hepato-Gastroenterologie HK, s.r.o.
🇨🇿Hradec Kralove, Czech Republic
Aalborg Hospital
🇩🇰Aalborg, Denmark
Klinicke Centrum ISCARE I.V.F.
🇨🇿Praha 7, Czech Republic
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
🇭🇺Szeged, Hungary
Aichi Medical University Hospital
🇯🇵Nagakute, Aichi, Japan
Kuniyoshi Hospital
🇯🇵Kochi-shi, Kochi, Japan
National Hospital Organization Mito Medical Center
🇯🇵Higashi-ibaraki-gun, Ibaraki, Japan
Showa University Hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
The Hospital of Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
🇷🇺Pyatigorsk, Stavropol Region, Russian Federation
Southern District Health Board
🇳🇿Dunedin, New Zealand
Shakespeare Specialist Group
🇳🇿Milford, Auckland, New Zealand
Cabinet Particular Policlinic Algomed SRL
🇷🇴Timisoara, Jud Timis, Romania
Lexmedica
🇵🇱Wroclaw, Poland
General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
🇷🇸Zrenjanin, Serbia, Europe, Serbia
Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"
🇷🇺Novosibirsk, Russian Federation
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
State Institution "National L.T. Malaya Therapy Institute of National Academy
🇺🇦Kharkov, Ukraine
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2
🇺🇦Vinnytsia, Ukraine
University College London Hospital
🇬🇧London, United Kingdom
Digestive Diseases Center GASTRO
🇱🇻Riga, Latvia
Kitasato University Kitasato Institute Hospital
🇯🇵Minato-ku, Tokyo, Japan
NTT Medical Center Tokyo
🇯🇵Shinagawa-ku, Tokyo, Japan