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A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis (OCTAVE)

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.
ClinicalTrials.gov Identifier: NCT01458951
Recruitment Status : Completed
First Posted : October 25, 2011
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: tofacitinib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 547 participants
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.
Study Start Date : June 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tofacitinib 10 mg BID Drug: tofacitinib
10 mg oral BID
Other Name: CP-690,550

Placebo Comparator: Placebo BID Drug: Placebo
Placebo oral BID




Primary Outcome Measures :
  1. 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 . 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 :
  1. 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.

  2. 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 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.

  3. 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.

  4. 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 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.

  5. Percentage of Participants With Symptomatic Remission at Week 8 [ Time Frame: 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.

  6. 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 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.

  7. Partial Mayo Scores [ Time Frame: 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.

  8. 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) 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.

  9. Change From Baseline in Total Mayo Score 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 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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.

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): NCT01458951


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Locations
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United States, Arizona
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
Desert Sun Gastroenterology
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center
Tucson, Arizona, United States, 85710
United States, California
Alliance Clinical Research
Oceanside, California, United States, 92056
Clinical Application Laboratories
San Diego, California, United States, 92103
San Diego Endoscopy Center
San Diego, California, United States, 92103
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, United States, 94115
University of California San Francisco
San Francisco, California, United States, 94115
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502
United States, Connecticut
Bristol Hospital
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States, 06010
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Central Connecticut Endoscopy Center
Plainville, Connecticut, United States, 06062
United States, Florida
Citrus Surgery & Endoscopy Center (Colonoscopy)
Crystal River, Florida, United States, 34429
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Suncoast Endoscopy Center (colonoscopy)
Inverness, Florida, United States, 34453
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Advanced Gastroenterology Center
Port Orange, Florida, United States, 32127
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Endoscopy Center
Port Orange, Florida, United States, 32127
Port Orange Urgent Care
Port Orange, Florida, United States, 32127
United States, Georgia
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States, 30033
United States, Kansas
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States, 66606
United States, Louisiana
Gastrointestinal Specialists, A.M.C.
Shreveport, Louisiana, United States, 71103
Shreveport Endoscopy Center, A.M.C.
Shreveport, Louisiana, United States, 71103
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
United States, Maryland
Chevy Chase Endoscopy Center (Endoscopies Only)
Chevy Chase, Maryland, United States, 20815
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Center for Digestive Health
Troy, Michigan, United States, 48098
Surgical Centers of Michigan
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Surgery Center of Columbia
Columbia, Missouri, United States, 65201
Hannibal Regional Hospital
Hannibal, Missouri, United States, 63401
Audrain Medical Center
Mexico, Missouri, United States, 65265
Center for Digestive & Liver Disease, Inc.
Mexico, Missouri, United States, 65265
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
South Jersey Gastroenterology
Marlton, New Jersey, United States, 08053
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States, 08360
The Endo Center at Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolina Research - Carolina Digestive Diseases
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, United States, 37212-1375
Vanderbilt University Medical Center - GI Research Office
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center - Drug Shipment
Nashville, Tennessee, United States, 37232-7610
Vanderbilt University Medical Center - GCRC
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - Heart Station
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - Radiology
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Clinical Research Institiute
Arlington, Texas, United States, 76012
Austin Gastroenterology PA/Professional Quality Research, Inc.
Austin, Texas, United States, 78705
Austin Gastroenterology PA
Austin, Texas, United States, 78745
Austin Endoscopy Center II
Austin, Texas, United States, 78746
Memorial Hermann Hospital
Houston, Texas, United States, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Virginia
VCU Health System Digestive Health Center
Richmond, Virginia, United States, 23298
VCU Health System Endoscopy Suite
Richmond, Virginia, United States, 23298
VCU Medical Center Investigational Drug Service (IDS)
Richmond, Virginia, United States, 23298
Virginia Commonwealth University, Clinical Research Services (CRSU)
Richmond, Virginia, United States, 23298
Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord Hospital -Concord Repatriation Hospital
Concord, New South Wales, Australia, 2139
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Liverpool Hospital Eastern Campus
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austria
Medizinische Universitat Innsbruck
Innsbruck, Austria, 6020
Krankenhaus Barmherzige Brueder St. Veit/Glan
St. Veit an der Glan, Austria, 9300
Belgium
GZA St Vincentius
Antwerpen, Belgium, 2018
AZ Groeninge, Campus Kennedylaan
Kortrijk, Belgium, 8500
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, Belgium, 8800
Brazil
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Canada, Alberta
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta - Zeidler Ledcor Centre
Edmonton, Alberta, Canada, T6G 2X8
Canada, Quebec
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Instituto de Coloproctologia ICO S.A.S.
Medellin, Antioquia, Colombia, 00000
Croatia
University Hospital Center Osijek, Clinic of Internal Medicine,
Osijek, Croatia, 31000
University Hospital Center Rijeka
Rijeka, Croatia, 51000
University Hospital Center Zagreb,Department of Gastroenterology
Zagreb, Croatia, 10000
Czech Republic
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, Czech Republic, 386 29
Krajska Zdravotni a.s., Masarykova nemocnice Usti nad Labem, o.z.
Usti nad Labem, Czech Republic, 40113
Denmark
Bispebjerg Hospital
Copenhagen, NV, Denmark, 2400
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense C, Denmark, 5000
Estonia
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Tallinn, Estonia, 10117
Innomedica OU
Tallinn, Estonia, 10117
X-Ray Unit, Qualitas AS (X-Ray Only)
Tallinn, Estonia, 10117
East Tallinn Central Hospital Internal Medicine Clinic
Tallinn, Estonia, 10138
ECG Unit, East Tallinn Central Hospital
Tallinn, Estonia, 10138
X-Ray Unit, East Tallinn Central Hospital
Tallinn, Estonia, 10138
Quattromed HTI Laboratorid OU
Tallinn, Estonia, 12618
Mammograaf OU (Endoscopy Only)
Tallinn, Estonia, 13419
France
CHU Amiens PICARDIE - Hopital SUD
Amiens Cedex 1, France, 80054
Hopital Saint Andre
Bordeaux cedex, France, 33075
Hopital Beaujon
Clichy Cedex, France, 92110
Hopital Saint Antoine
Paris Cedex 12, France, 75571
C.H.U. de Reims - Hôpital Robert Debré
Reims cedex, France, 51092
Hopital Nord
St Priest En Jarez, France, 42270
Germany
Universitäetsklinik Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, Germany, 24105
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, Germany, 60590
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Germany, 32423
University Hospital Munich-Grosshadern
Munich, Germany, 81377
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Hungary
Dr. Rethy Pal Korhaz-Rendelointezet- III. Belgyogyaszat
Bekescsaba, Europe, Hungary, 5600
Szent Janos Korhaz és Eszak-budai Egyesített Korhazak I Belgyogyaszat-Gasztroenterologiai Osztaly
Budapest, Hungary, 1125
Peterfy Sandor utcai Korhaz- Rendelointezet es Baleseti Kozpontl. Belgyogyaszat
Budapest, Hungary, H-1076
MH Honvedkorhaz
Budapest, Hungary, H-1134
Pannonia Maganorvosi Centrum Kft.
Budapest, Hungary, H-1135
Debreceni Egyetem Klinikai Központ Belgyógyászati Intézet, Gasztroenterológiai Tanszék
Debrecen, Hungary, 4032
Bekes Megyei Pandy Kalman Korhaz
Gyula, Hungary, H-5700
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
"Karolina Korhaz Rendelointezet,Belgyogyaszat
Mosonmagyarovar, Hungary, 9200
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
The Edith Wolfson Medical Center/Gastroenterology Institute
Holon, Israel, 58100
Kaplan Medical Center
Rehovot, Israel, 76100
Korea, Republic of
Hanyang University Guri Hospital, Clinical Laboratory
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Latvia
Daugavpils Regional Hospital
Daugavpils, Latvia, LV-5417
Netherlands
VU University Medical Center (VUMC)
Amsterdam, Netherlands, 1081 HV
Academic Medical Centre (AMC),
Amsterdam, Netherlands, 1105AZ
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9713 GZ
New Zealand
Christchurch Hospital
Christchurch, Canterbury, New Zealand, 8011
Auckland City Hospital
Auckland, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3240
P3 Research Limited
Wellington, New Zealand, 6021
Pacific Radiology (X-rays only)
Wellington, New Zealand, 6021
Bowen Hospital
Wellington, New Zealand, 6035
Poland
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Lodz, Iodzkie, Poland, 90-302
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Oddzial Chorob Wewnetrznych i Gastroenterologii,
Bialystok, Podlaskie, Poland, 15-950
H-T Centrum Medyczne sp. z o.o. sp. komandytowa
Tychy, Slaskie, Poland, 43100
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
Endoskopia Sp. z.o.o.
Sopot, Poland, 81-756
Nzoz Vivamed
Warszawa, Poland, 03-580
Romania
Spitalul Universitar de Urgenta Bucuresti, Sectia de Medicina Interna 2 si Gastroenterologie
Bucuresti, Sector 5, Romania, cod 050098
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie
jud. Mures, Romania, 540103
Russian Federation
State budget institution of healthcare "City Clinical Hospital # 51 healthcare department of Moscow"
Moscow, Russia, Russian Federation, 121309
Municipal institution of healthcare "Clinical Hospital # 2"
Yaroslavl, Russia, Russian Federation, 150010
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo"
Yaroslavl, Russia, Russian Federation, 150040
Federal state budget institution "State scientific centre of coloproctology"
Moscow, Russian Federation, 123423
State budget Healthcare Institution Moscow regional scientific research clinical institute
Moscow, Russian Federation, 129110
Federal State Budgetary Institution "Scientific Research Institute of Physiology and
Novosibirsk, Russian Federation, 630117
Municipal institution of healthcare "City clinical hospital 12"
Saratov, Russian Federation, 410039
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
Yaroslavl, Russian Federation, 150062
Serbia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, Serbia, 11000
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
Novi Sad, Serbia, 21000
Clinical Centre of Vojvodina, Emergency Internal Medicine Division
Novi Sad, Serbia, 21000
General Hospital Subotica
Subotica, Serbia, 24000
Slovakia
Lama Medical Care s.r.o., Gastroenterologicko-Hepatologicke centrum Thalion
Bratislava, Slovakia, 831 04
KM Management spol. s r.o.
Nitra, Slovakia, 949 01
Aura SA, s.r.o.
Nove Mesto Nad Vahom, Slovakia, 91501
Gastro I., s.r.o.
Presov, Slovakia, 08001
South Africa
Panorama Medi-Clinic
Cape Town, Western Cape, South Africa, 7500
The Louis Leipoldt Medical Centre
Cape Town, Western Cape, South Africa, 7530
Dr JP Wright
Claremont, Cape Town, Western Cape, South Africa, 7708
Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital Universitario de Bellvitge
Barcelona, Spain, 08907
Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
National Taiwan University Hospital
Taipei City, Taiwan, 10002
Ukraine
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi,, Ukraine, 58001
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Ukraine, 58001
State Institution Institute of Gastroenterology of the National Academy of Medical Sciences
Dnipropetrovsk, Ukraine, 49074
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
Kharkiv, Ukraine, 61037
Kyiv City Clinical Hospital #8,
Kiev, Ukraine, 04201
Municipal Institution "Odesa Regional Clinical Hospital"
Odesa, Ukraine, 65025
Medical Clinical Research Center "Health Clinic" on the base of
Vinnytsya, Ukraine, 21029
Motor-Sich clinic, LLC
Zaporizhzhia, Ukraine, 69068
Minicipal Institution "City Hospital #7" Therapeutic Department,
Zaporizhzhia, Ukraine, 69118
United Kingdom
Department of Gastroenterology, Old Building
Bristol, England, United Kingdom, BS2 8HW
St Mark's Hospital
Harrow, Middlesex, United Kingdom, HA1 3UJ
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458951     History of Changes
Other Study ID Numbers: A3921095
2011-004579-35 ( EudraCT Number )
OCTAVEINDUCTION2 ( Other Identifier: Alias Study Number )
First Posted: October 25, 2011    Key Record Dates
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016
Last Verified: April 2016

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

Additional relevant MeSH terms:
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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