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Trial record 1 of 1 for:    A3921094
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A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis (OCTAVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01465763
First Posted: November 7, 2011
Last Update Posted: June 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis Drug: tofacitinib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Remission at Week 8 [ Time Frame: 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:
  • Percentage of Participants Achieving Mucosal Healing at Week 8 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 614
Study Start Date: April 2012
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tofacitinib 10 mg BID Drug: tofacitinib
10 mg oral BID
Other Name: CP-690,550
Placebo Comparator: Placebo Drug: Placebo
Plabebo oral BID

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465763


  Hide Study Locations
Locations
United States, Alabama
Internal Medicine Center, LLC
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital
Mobile, Alabama, United States, 36608
United States, California
Investigational Drug Service Pharmacy
La Jolla, California, United States, 92093
UCSD Medical Center
La Jolla, California, United States, 92093
UCSD Medical Centre
La Jolla, California, United States, 92093
Cedars Sinai Medical Center - Thalians Bldg
Los Angeles, California, United States, 90048
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Cedars Sinai Surgery Center
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center
Los Angeles, California, United States, 90048
Desert Advanced Imaging
Palm Springs, California, United States, 92262
Erik Palmer, DO
Palm Springs, California, United States, 92262
Homan A Zadeh, MD, MPH
Palm Springs, California, United States, 92262
Hope Square Surgical Center
Rancho Mirage, California, United States, 92270
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group,Inc
San Diego, California, United States, 92123
United States, Connecticut
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, United States, 06437
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, United States, 06518
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
United States, Florida
Florida Surgery Center
Altamonte Springs, Florida, United States, 32701
Center for Advanced Gastroenterology
Maitland, Florida, United States, 32751
MNH Surgical Center
Maitland, Florida, United States, 32751
Sand Lake Imaging
Maitland, Florida, United States, 32751
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States, 32073
Orange Park Surgery Center
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center
Orlando, Florida, United States, 32806
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center (Colonoscopy only)
Alpharetta, Georgia, United States, 30005
GI Consultants (Colonoscopy only)
Atlanta, Georgia, United States, 30342
Emory Healthcare Heart Center (EKG)
Johns Creek, Georgia, United States, 30097
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States, 31201
Icahn School of Medicine at Mount Sinai
Marietta, Georgia, United States, 30067
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States, 30024
Johns Creek Diagnostic Center (X-Ray only)
Suwanee, Georgia, United States, 30024
United States, Illinois
Southwest Gastroenterology
Oak Lawn, Illinois, United States, 60453
United States, Michigan
Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)
Ann Arbor, Michigan, United States, 48106
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-5000
Michigan Clinical Research Unit - Univeristy of Michigan Health System
Ann Arbor, Michigan, United States, 48109-5872
Medical Science Research Building 1 - University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Michigan Heart SJMH (Blood draws and ECGs only)
Ypsilanti, Michigan, United States, 48106
Huron Gastroenterology Associates / Center for Digestive Care
Ypsilanti, Michigan, United States, 48197
Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)
Ypsilanti, Michigan, United States, 48197
United States, Missouri
Center for Advanced Medicine
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine - Division of Gastroenterology
Saint Louis, Missouri, United States, 63110
United States, New York
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States, 11021
The Private Practice of Simon Lichtiger, MD
New York, New York, United States, 10028
Mount Sinai Doctos Faculty Practice
New York, New York, United States, 10029
Mount Sinai Medical Center
New York, New York, United States, 10029
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
CUMC Research Pharmacy
New York, New York, United States, 10032
Kornbluth, Legnani, George MD, PC
New York, New York, United States, 10128
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
Mentor Medical Campus
Mentor, Ohio, United States, 44060
The Endoscopy Center of Lake County
Mentor, Ohio, United States, 44060
United States, Texas
Houston Hospital for Specialized Surgery
Houston, Texas, United States, 77004
Baylor College of Medicine (Baylor Medical Center)
Houston, Texas, United States, 77030
Baylor College of Medicine - Baylor Medical Center (Drug Storage)
Houston, Texas, United States, 77030
Gastroenterology Consultants, P.A.
Houston, Texas, United States, 77034
United States, Utah
Alpine Medical Group
Salt Lake City, Utah, United States, 84102
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Wasatch Endoscopy Center
Salt Lake City, Utah, United States, 84124
RGL Medical Services (x-ray only)
West Jordan, Utah, United States, 84084
United States, Wisconsin
Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Australia, Victoria
Eastern Health Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III,
Wien, Austria, 1090
Belgium
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, Belgium, 3000
Canada, Alberta
Hertiage Medical Research Clinic- University Of Calgary
Calgary, Alberta, Canada, T2N 4Z6
Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences Corporation - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4K1
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Colombia
Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A.
Barranquilla, Atlantico, Colombia, 00000
Croatia
General Hospital Zadar
Zadar, Croatia, 23 000
Czech Republic
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czech Republic, 500 12
Institut klinicke a experimentalni mediciny
Praha 4, Czech Republic, 140 21
Klinicke Centrum ISCARE I.V.F.
Praha 7, Czech Republic, 170 04
Denmark
Aalborg Hospital
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus C, Denmark, 8000
Estonia
ECG Unit of West Tallinn Central Hospital
Tallinn, Estonia, 10617
West Tallinn Central Hospital Internal Diseases Clinic
Tallinn, Estonia, 10617
X-Ray Department of West Tallinn Central Hospital
Tallinn, Estonia, 10617
France
CHU de Nantes - Hotel Dieu
Nantes, France, 44093
Hopital Saint-Louis
Paris, France, 75010
Hopital Rangueil
Toulouse Cedex 9, France, 31059
Germany
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
Berlin, Germany, 13353
Universitaetsklinikum Halle (Saale)
Halle, Germany, 06120
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Klinikum Luneburg/Abteilung Gastroenterologie
Lüneburg, Germany, 21339
Hungary
Szent Margit Korhaz III Belgyogyaszati Gasztroenterologiai Osztaly
Budapest, Hungary, 1032
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, Hungary, 7624
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar I. sz. Belgyogyaszati Klinika
Szeged, Hungary, 6720
Javorszky Odon Korhaz/Gasztroenterologiai Osztaly
Vac, Hungary, H-2600
Israel
Rabin Medical Center, Beilinson campus
Petah Tikva, Israel, 49100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
AOU Mater Domini - U.O. Fisiopatologia Digestiva
Catanzaro, CZ, Italy, 88100
Istituto Clinico Humanitas IRCSS
Rozzano, Milano, Italy, 20089
A.O.R. Villa Sofia- Cervello
Palermo, PA, Italy, 90146
Comitato Etico Palermo 2
Palermo, PA, Italy, 90146
SOC Gastroenterologia Centro di Riferimento Oncologico
Aviano, Italy, 33081
IBD Center - IRCCS Humanitas
Milan, Italy, 20089
Japan
Aichi Medical University Hospital
Nagakute, Aichi, Japan, 480-1195
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, Japan, 036-8545
Chiba University Hospital
Chiba-shi, Chiba, Japan, 260-8677
Toho University Sakura Medical Center
Sakura, Chiba, Japan, 285-8741
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan, 060-0033
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Mito Medical Center
Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
Kuniyoshi Hospital
Kochi-shi, Kochi, Japan, 780-0901
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan, 983-8520
Osaka Medical College Hospital
Takatsuki-shi, Osaka, Japan, 569-8686
Shiga University of Medical Science Hospital
Otsu-shi, Shiga, Japan, 520-2192
Tokai University Hachioji Hospital
Hachioji, Tokyo, Japan, 192-0032
Jikei University Hospital
Minato-ku, Tokyo, Japan, 105-8471
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan, 108-8642
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan, 141-8625
Showa University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Fukuoka University Chikushi Hospital
Fukuoka, Japan, 818-8502
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Sameshima Hospital
Kagoshima, Japan, 892-0846
Osaka City University Hospital
Osaka, Japan, 545-8586
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Tokyo, Japan, 113-8519
Keio University Hospital
Tokyo, Japan, 160-8582
Latvia
Digestive Diseases Center GASTRO
Riga, Latvia, LV-1006
ECG room, Clinic "Linezers"
Riga, Latvia, LV-1006
X-Ray Department, Clinic "Linezers"
Riga, Latvia, LV-1006
Netherlands
Leiden University Medical Center
Leiden, ZH, Netherlands, 2333 ZA
New Zealand
Shakespeare Specialist Group
Milford, Auckland, New Zealand, 0620
Southern District Health Board
Dunedin, New Zealand, 9016
Bop Clinical School Clinical Trials Unit
Tauranga, New Zealand, 3143
Poland
Gabinet Lekarski - Janusz Rudzinski
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia
Warszawa, Mazowieckie, Poland, 02-507
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SP ZOZ Uniwersytecki
Lodz, Poland, 90-153
Lexmedica
Wroclaw, Poland, 53-114
Romania
Cabinet Particular Policlinic Algomed SRL
Timisoara, Jud Timis, Romania, 300002
Russian Federation
Municipal budget institution of healthcare "Central City Hospital of Pyatigorsk"
Pyatigorsk, Stavropol Region, Russian Federation, 357500
State budgetInstitution ofHealthcare Nizhniy NovgorodRegionalClinicalHospital namedafterN.A.Semashko
Nizhniy Novgorod, Russian Federation, 603126
Federal State Institution "Sibirian regional Medical Centre of Federal Medicobiologic Agency"
Novosibirsk, Russian Federation, 630068
Municipal budget institution of healthcare of Novosibirsk "City Clinical Hospital
Novosibirsk, Russian Federation, 630084
State Budget Educational Institution of Higher Professional Education
Novosibirsk, Russian Federation, 630091
GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov"
Saint-Petersburg, Russian Federation, 191015
GUZ City Hospital #26
Saint-Petersburg, Russian Federation, 196247
Non-State Healthcare Institution "Road Clinical Hispital at the station Samara" of Open Joint-Stock
Samara, Russian Federation, 443029
Limited Liability Company Medical Company "Hepatolog"
Samara, Russian Federation, 443093
Samara Diagnostic center, X-ray Department
Samara, Russian Federation, 443093
Federal State Budgetary Military Educational Institution of High Professional Education
St. Petersburg, Russian Federation, 191015
Serbia
General Hospital "Djordje Joanovic" Department for Gastroenterology and Hepatology
Zrenjanin, Serbia, Europe, Serbia, 23000
Clinical Hospital Centre Zvezdara
Belgrade, Serbia, 11000
Military Medical Academy
Belgrade, Serbia, 11000
Clinical Centre of Kragujevac
Kragujevac, Serbia, 34000
Slovakia
Medak s.r.o.
Bratislava, Slovakia, 85101
South Africa
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa, 2013
Endocare Research Centre
Cape Town, Western Cape, South Africa, 7646
Spain
Hospital Clínic i provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Ukraine
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity"University
Simferopol, Ar Krym, Ukraine, 95017
State Institution "National L.T. Malaya Therapy Institute of National Academy
Kharkov, Ukraine, 61039
Kyiv Municipal Clinical Hospital #18, Proctology Department
Kyiv, Ukraine, 01030
LTD "St. Paraskeva Medical Center"
Lviv, Ukraine, 79019
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
Lviv, Ukraine, 79059
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
Odesa, Ukraine, 65010
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI
Uzhgorod, Ukraine, 88009
Vinnytsia National Medical University
Vinnytsia, Ukraine, 21005
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2
Vinnytsia, Ukraine, 21005
United Kingdom
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
University College London Hospital
London, United Kingdom, NW1 2BU
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01465763     History of Changes
Other Study ID Numbers: A3921094
2011-004578-27 ( EudraCT Number )
OCTAVEINDUCTION1 ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2011
First Posted: November 7, 2011
Results First Submitted: May 1, 2016
Results First Posted: June 7, 2016
Last Update Posted: June 7, 2016
Last Verified: May 2016

Keywords provided by Pfizer:
tofacitinib
CP-690
550
Moderate to severe ulcerative colitis
phase 3 clinical trial
Mayo score

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action