A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
- Registration Number
- NCT01458951
- 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
- 547
-
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 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 BID 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 . 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 score 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 sub score of at least 1 point or an absolute rectal bleeding sub score 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 flexible centrally read 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 score 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 flexible centrally read 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 score indicating more severe disease.
Percentage of Participants With Symptomatic Remission at Week 8 Week 8 Symptomatic remission 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 flexible centrally read 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 score 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 flexible centrally read 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 score indicating more severe disease.
Partial Mayo Scores Baseline, Weeks 2, 4, 8 A partial mayo score (mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) and 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) ranges 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 graded from 0 to 3 with higher scores indicating more severe disease.
Change From Baseline in Total Mayo Score 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 flexible centrally read 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 score indicating more severe disease.
Trial Locations
- Locations (181)
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
H-T Centrum Medyczne sp. z o.o. sp. komandytowa
🇵🇱Tychy, Slaskie, Poland
Atlanta Center for Gastroenterology, P.C.
🇺🇸Decatur, Georgia, United States
Texas Clinical Research Institiute
🇺🇸Arlington, Texas, United States
The Louis Leipoldt Medical Centre
🇿🇦Cape Town, Western Cape, South Africa
Citrus Surgery & Endoscopy Center (Colonoscopy)
🇺🇸Crystal River, Florida, United States
Shreveport Endoscopy Center, A.M.C.
🇺🇸Shreveport, Louisiana, United States
Desert Sun Surgery Center
🇺🇸Tucson, Arizona, United States
Central Connecticut Endoscopy Center
🇺🇸Plainville, Connecticut, United States
Austin Gastroenterology PA
🇺🇸Austin, Texas, United States
Austin Endoscopy Center II
🇺🇸Austin, Texas, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Suncoast Endoscopy Center (colonoscopy)
🇺🇸Inverness, Florida, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
South Jersey Gastroenterology
🇺🇸Marlton, New Jersey, United States
The Endo Center at Voorhees
🇺🇸Voorhees, New Jersey, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Cotton-O'Neil Clinical Research Center, Digestive Health
🇺🇸Topeka, Kansas, United States
Gastrointestinal Specialists, A.M.C.
🇺🇸Shreveport, Louisiana, United States
Chevy Chase Endoscopy Center (Endoscopies Only)
🇺🇸Chevy Chase, Maryland, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Alliance Clinical Research
🇺🇸Oceanside, California, United States
Connecticut Clinical Research Foundation
🇺🇸Bristol, Connecticut, United States
Port Orange Urgent Care
🇺🇸Port Orange, Florida, United States
AZ Groeninge, Campus Kennedylaan
🇧🇪Kortrijk, Belgium
Austin Gastroenterology PA/Professional Quality Research, Inc.
🇺🇸Austin, Texas, United States
Hannibal Regional Hospital
🇺🇸Hannibal, Missouri, United States
Liverpool Hospital Eastern Campus
🇦🇺Liverpool, New South Wales, Australia
Surgical Centers of Michigan
🇺🇸Troy, Michigan, United States
Digestive Health Specialists of Tyler
🇺🇸Tyler, Texas, United States
Center for Digestive & Liver Disease, Inc.
🇺🇸Mexico, Missouri, United States
Carolina Research - Carolina Digestive Diseases
🇺🇸Greenville, North Carolina, United States
VCU Health System Digestive Health Center
🇺🇸Richmond, Virginia, United States
VCU Medical Center Investigational Drug Service (IDS)
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University, Clinical Research Services (CRSU)
🇺🇸Richmond, Virginia, United States
VCU Health System Endoscopy Suite
🇺🇸Richmond, Virginia, United States
The Canberra Hospital
🇦🇺Garran, Australian Capital Territory, Australia
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand
Gabinet Endoskopii Przewodu Pokarmowego
🇵🇱Krakow, Poland
Endoskopia Sp. z.o.o.
🇵🇱Sopot, Poland
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Medical Clinical Research Center "Health Clinic" on the base of
🇺🇦Vinnytsya, Ukraine
Clinical Application Laboratories
🇺🇸San Diego, California, United States
San Diego Endoscopy Center
🇺🇸San Diego, California, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Rochester
🇺🇸Rochester, New York, United States
Hospital de Clinicas de Porto Alegre - HCPA
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil
Vanderbilt University Medical Center - GI Research Office
🇺🇸Nashville, Tennessee, United States
UCSF Endoscopy Unit at Mount Zion
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center - Heart Station
🇺🇸Nashville, Tennessee, United States
University of California San Francisco
🇺🇸San Francisco, California, 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 - GCRC
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center - Radiology
🇺🇸Nashville, Tennessee, United States
Krankenhaus Barmherzige Brueder St. Veit/Glan
🇦🇹St. Veit an der Glan, Austria
Saskatoon City Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
🇷🇴jud. Mures, Romania
Nemocnice Strakonice, a.s., Interni oddeleni
🇨🇿Strakonice, Czech Republic
ECG Unit, East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
General Hospital Subotica
🇷🇸Subotica, Serbia
Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
🇷🇴Bucuresti, Sector 5, Romania
Clinical Centre of Vojvodina, Emergency Internal Medicine Division
🇷🇸Novi Sad, Serbia
Oddzial Chorob Wewnetrznych i Gastroenterologii,
🇵🇱Bialystok, Podlaskie, Poland
National Taiwan University Hospital
🇨🇳Taipei City, Taiwan
Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
🇸🇰Bratislava, Slovakia
Department of Gastroenterology, Old Building
🇬🇧Bristol, England, United Kingdom
"Karolina Korhaz Rendelointezet,Belgyogyaszat
🇭🇺Mosonmagyarovar, Hungary
Advanced Medical Research Center
🇺🇸Port Orange, Florida, United States
Desert Sun Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Desert Sun Gastroenterology
🇺🇸Tucson, Arizona, United States
Advanced Gastroenterology Center
🇺🇸Port Orange, Florida, United States
Gastroenterology Group of Naples
🇺🇸Naples, Florida, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Surgery Center of Columbia
🇺🇸Columbia, Missouri, United States
AGA Clinical Research Associates, LLC
🇺🇸Egg Harbor Township, New Jersey, United States
The Gastroenterology Group of South Jersey
🇺🇸Vineland, New Jersey, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
GZA St Vincentius
🇧🇪Antwerpen, Belgium
Medizinische Universitat Innsbruck
🇦🇹Innsbruck, Austria
H-Hartziekenhuis Roeselare-Menen vzw
🇧🇪Roeselare, Belgium
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
University Hospital Center Rijeka
🇭🇷Rijeka, Croatia
Montreal General Hospital - McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
University of Alberta - Zeidler Ledcor Centre
🇨🇦Edmonton, Alberta, Canada
Instituto de Coloproctologia ICO S.A.S.
🇨🇴Medellin, Antioquia, Colombia
University Hospital Center Osijek, Clinic of Internal Medicine,
🇭🇷Osijek, Croatia
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
🇨🇿Usti nad Labem, Czech Republic
University Hospital Center Zagreb,Department of Gastroenterology
🇭🇷Zagreb, Croatia
Bispebjerg Hospital
🇩🇰Copenhagen, NV, Denmark
Hvidovre University Hospital
🇩🇰Hvidovre, Denmark
Hopital Beaujon
🇫🇷Clichy Cedex, France
Odense University Hospital
🇩🇰Odense C, Denmark
Quattromed HTI Laboratorid OU
🇪🇪Tallinn, Estonia
X-Ray Unit, East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
🇪🇪Tallinn, Estonia
Innomedica OU
🇪🇪Tallinn, Estonia
X-Ray Unit, Qualitas AS (X-Ray Only)
🇪🇪Tallinn, Estonia
East Tallinn Central Hospital Internal Medicine Clinic
🇪🇪Tallinn, Estonia
CHU Amiens PICARDIE - Hopital SUD
🇫🇷Amiens Cedex 1, France
Mammograaf OU (Endoscopy Only)
🇪🇪Tallinn, Estonia
Hopital Saint Antoine
🇫🇷Paris Cedex 12, France
Hopital Saint Andre
🇫🇷Bordeaux cedex, France
Klinikum der Johann Wolfgang Goethe-Universitaet
🇩🇪Frankfurt, Germany
Universitäetsklinik Schleswig-Holstein, Campus Kiel
🇩🇪Kiel, Schlewig Holstein, Germany
Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
🇭🇺Bekescsaba, Europe, Hungary
Universitaetsklinikum Ulm
🇩🇪Ulm, Germany
Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
🇭🇺Budapest, Hungary
MH Honvedkorhaz
🇭🇺Budapest, Hungary
Pannonia Maganorvosi Centrum Kft.
🇭🇺Budapest, Hungary
Hanyang University Guri Hospital, Clinical Laboratory
🇰🇷Guri-si, Gyeonggi-do, Korea, Republic of
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
🇭🇺Miskolc, Hungary
Kaplan Medical Center
🇮🇱Rehovot, Israel
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
The Edith Wolfson Medical Center/Gastroenterology Institute
🇮🇱Holon, Israel
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Daugavpils Regional Hospital
🇱🇻Daugavpils, Latvia
VU University Medical Center (VUMC)
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen (UMCG)
🇳🇱Groningen, Netherlands
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
🇵🇱Lodz, Iodzkie, Poland
Christchurch Hospital
🇳🇿Christchurch, Canterbury, New Zealand
Academic Medical Centre (AMC),
🇳🇱Amsterdam, Netherlands
Waikato Hospital
🇳🇿Hamilton, New Zealand
Pacific Radiology (X-rays only)
🇳🇿Wellington, New Zealand
Bowen Hospital
🇳🇿Wellington, New Zealand
Nzoz Vivamed
🇵🇱Warszawa, Poland
Municipal institution of healthcare "Clinical Hospital # 2"
🇷🇺Yaroslavl, Russia, Russian Federation
State budget Healthcare Institution Moscow regional scientific research clinical institute
🇷🇺Moscow, Russian Federation
Federal state budget institution "State scientific centre of coloproctology"
🇷🇺Moscow, Russian Federation
Federal State Budgetary Institution "Scientific Research Institute of Physiology and
🇷🇺Novosibirsk, Russian Federation
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
🇷🇸Belgrade, Serbia
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
🇷🇺Yaroslavl, Russian Federation
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
🇷🇸Novi Sad, Serbia
KM Management spol. s r.o.
🇸🇰Nitra, Slovakia
Aura SA, s.r.o.
🇸🇰Nove Mesto Nad Vahom, Slovakia
Gastro I., s.r.o.
🇸🇰Presov, Slovakia
Panorama Medi-Clinic
🇿🇦Cape Town, Western Cape, South Africa
Dr JP Wright
🇿🇦Claremont, Cape Town, Western Cape, South Africa
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Chung Shan Medical University Hospital
🇨🇳Taichung, Taiwan
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
🇺🇦Chernivtsi,, Ukraine
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
🇺🇦Chernivtsi, Ukraine
State Institution Institute of Gastroenterology of the National Academy of Medical Sciences
🇺🇦Dnipropetrovsk, Ukraine
Kyiv City Clinical Hospital #8,
🇺🇦Kiev, Ukraine
Municipal Institution "Odesa Regional Clinical Hospital"
🇺🇦Odesa, Ukraine
Motor-Sich clinic, LLC
🇺🇦Zaporizhzhia, Ukraine
Minicipal Institution "City Hospital #7" Therapeutic Department,
🇺🇦Zaporizhzhia, Ukraine
St Mark's Hospital
🇬🇧Harrow, Middlesex, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Concord Hospital -Concord Repatriation Hospital
🇦🇺Concord, New South Wales, Australia
Audrain Medical Center
🇺🇸Mexico, Missouri, United States
Bristol Hospital
🇺🇸Bristol, Connecticut, United States
Endoscopy Center
🇺🇸Port Orange, Florida, United States
C.H.U. de Reims - Hôpital Robert Debré
🇫🇷Reims cedex, France
University Hospital Munich-Grosshadern
🇩🇪Munich, Germany
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Gastroenterologische Gemeinschaftspraxis Minden
🇩🇪Minden, Germany
Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
🇭🇺Budapest, Hungary
Hopital Nord
🇫🇷St Priest En Jarez, France
Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
🇭🇺Debrecen, Hungary
Rambam Health Care Campus
🇮🇱Haifa, Israel
Bekes Megyei Pandy Kalman Korhaz
🇭🇺Gyula, Hungary
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
P3 Research Limited
🇳🇿Wellington, New Zealand
State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
🇷🇺Moscow, Russia, Russian Federation
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
🇷🇺Yaroslavl, Russia, Russian Federation
Municipal institution of healthcare "City clinical hospital 12"
🇷🇺Saratov, Russian Federation
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
🇺🇦Kharkiv, Ukraine
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States