Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis (OCTAVE)

A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: CP-690,550; Drug: CP-690,550

• Study Type: Interventional
• Enrollment (Actual): 944
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • The Canberra Hospital
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital eastern Campus
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health, Box Hill Hospital
    • Clayton, Victoria, Australia, 3168
      • Gastroenterology and Hepatology Unit
• Austria
  • Innsbruck, Austria, 6020
    • Landeskrankenhaus Innsbruck
  • St. Veit an der Glan, Austria, 9300
    • Krankenhaus Barmherzige Brueder St. Veit/Glan
  • Wien, Austria, 1090
    • AKH Wien, Universitaetsklinik fuer Innere Medizin III
• Belgium
  • Antwerpen, Belgium, 2018
    • GZA St Vincentius
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Leuven, Belgium, 3000
    • UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
  • Roeselare, Belgium, 8800
    • H-Hartziekenhuis Roeselare-Menen vzw
• Brazil
  • RIO Grande DO SUL
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90035-003
      • Hospital de Clinicas de Porto Alegre - HCPA
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary, Heritage Medical Research Clinic, TRW Building
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
    • Edmonton, Alberta, Canada, T6G 2X8
      • University of Alberta - Zeidler Ledcor Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Medical Center
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny
    • Montreal, Quebec, Canada, H3G 1A4
      • Montreal General Hospital - McGill University Health Care Centre
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
    • Saskatoon, Saskatchewan, Canada, S7K 0M7
      • Saskatoon City Hospital
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 00000
      • Instituto de Coloproctologia ICO S.A.S.
• Croatia
  • Zagreb, Croatia, 10 000
    • University hospital center Zagreb
• Czechia
  • Hradec Kralove, Czechia, 500 12
    • Hepato-Gastroenterologie HK, s.r.o.
  • Praha 7, Czechia, 170 04
    • Klinicke Centrum ISCARE I.V.F., Gastroenterologie
  • Strakonice, Czechia, 386 29
    • Nemocnice Strakonice, a.s., Interni oddeleni
  • Usti Nad Labem, Czechia, 401 13
    • Krajska Zdravotni, A.S.,
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Hospital
  • Aarhus C, Denmark, 8000
    • Aarhus University Hospital
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • Odense C, Denmark, 5000
    • Odense University Hospital
  • NV
    • Copenhagen, NV, Denmark, 2400
      • Bispebjerg Hospital
• Estonia
  • Tallinn, Estonia, 10117
    • Innomedica OÜ
  • Harjumaa
    • Tallinn, Harjumaa, Estonia, 10617
      • West Tallinn Central Hospital
• France
  • Amiens Cedex 01, France, 80054
    • CHU Amiens-Picardie - Hopital Sud
  • Clichy, France, 92110
    • Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive
  • Nantes, France, 44093
    • CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie
  • Paris, France, 75010
    • Hopital Saint Louis
  • Paris, France, 75010
    • Hôpital Saint Louis - Service d'hepato-gastroenterologie
  • Paris cedex 12, France, 75571
    • Hopital Saint Antoine - Service de Gastroenterologie
  • Pessac, France, 33604
    • Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique
  • Reims cedex, France, 51092
    • CHU de Reims - Hôpital Robert Debré
  • St Priest En Jarez, France, 42270
    • Hopital Nord
  • Toulouse Cedex 9, France, 31059
    • Hopital Rangueil
• Germany
  • Berlin, Germany, 13353
    • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit
  • Halle, Germany, 06120
    • Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Lüneburg, Germany, 21339
    • Klinikum Luneburg
  • Minden, Germany, 32423
    • Gastroenterologische Gemeinschaftspraxis Minden
  • Munich, Germany, 81377
    • University Hospital Munich-Grosshadern
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm
  • Schlewig Holstein
    • Kiel, Schlewig Holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein, Campus Kiel
• Hungary
  • Bekescsaba, Hungary, 5600
    • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.
  • Budapest, Hungary, 1136
    • Pannonia Maganorvosi Centrum Kft.
  • Budapest, Hungary, 1076
    • Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet
  • Budapest, Hungary, 1125
    • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly
  • Budapest, Hungary, H-1032
    • Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyula, Hungary, 5700
    • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia
  • Miskolc, Hungary, 3526
    • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • Mosonmagyarovar, Hungary, 9200
    • Karolina Korhaz
  • Pecs, Hungary, 7624
    • Pécsi Tudományegyetem Klinikai Központ
  • Szeged, Hungary, 6720
    • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
  • Vac, Hungary, 2600
    • Javorszky Odon Korhaz
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Holon, Israel, 58100
    • The Edith Wolfson Medical Center/Gastroenterology Department
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center, Beilinson Campus
• Italy
  • Catanzaro, Italy, 88100
    • AOU Mater Domini - U.O. Fisiopatologia Digestiva
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas IRCCS-IBD Center
  • PA
    • Palermo, PA, Italy, 90146
      • AOR Villa Sofia-Cervello
• Japan
  • Fukuoka, Japan, 818-8502
    • Fukuoka University Chikushi Hospital
  • Hiroshima, Japan, 734-8551
    • Hiroshima University Hospital
  • Hyogo, Japan, 663-8501
    • The Hospital of Hyogo College of Medicine
  • Tokyo, Japan, 142-8666
    • Showa University Hospital
  • Aichi
    • Nagakute, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8545
      • National Hospital Organization Hirosaki National Hospital
  • Chiba
    • Sakura, Chiba, Japan, 285-8741
      • Toho University Sakura Medical Center
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0033
      • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
  • Ibaraki
    • Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
      • National hospital Organization Mito Medical Center
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 892-0846
      • Sameshima Hospital
  • Kochi
    • Kochi-shi, Kochi, Japan, 780-0901
      • Kuniyoshi Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 983-8520
      • National Hospital Organization Sendai Medical Center
  • Osaka
    • Osaka-City, Osaka, Japan, 545-8586
      • Osaka City University Hospital
    • Takatsuki-shi, Osaka, Japan, 569-8686
      • Osaka Medical College Hospital
  • Shiga
    • Otsu, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Tokyo Medical And Dental University Hospital, Faculty of Medicine
    • Hachioji, Tokyo, Japan, 192-0032
      • Tokai University Hachioji Hospital
    • Minato-ku, Tokyo, Japan, 105-8471
      • Jikei University Hospital
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital
• Korea, Republic of
  • Incheon, Korea, Republic of, 21565
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital,
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 11923
      • Hanyang University GURI Hospital
• Latvia
  • Riga, Latvia, LV-1006
    • Digestive Diseases Center GASTRO
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU University Medical Center
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center (AMC)
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen (UMCG)
  • Leiden, Netherlands, 2333 ZA
    • Leiden University Medical Center
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital
  • Auckland, New Zealand, 0620
    • North Shore Hospital (Waitemata District Health Board)
  • Dunedin, New Zealand, 9016
    • Southern District Health Board
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Wellington, New Zealand, 6021
    • P3 Research Limited
  • BAY OF Plenty
    • Tauranga, BAY OF Plenty, New Zealand, 3112
      • Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital
• Poland
  • Krakow, Poland, 31-009
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Lodz, Poland, 90-153
    • Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr
  • Sopot, Poland, 81-756
    • ENDOSKOPIA Sp. z o.o.
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Wroclaw, Poland, 53-114
    • Lexmedica
  • Iodzkie
    • Lodz, Iodzkie, Poland, 90-302
      • Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
      • Gabinet Lekarski - Janusz Rudzinski
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 02-507
      • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-950
      • Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital
  • Slaskie
    • Tychy, Slaskie, Poland, 43-100
      • H-T. Centrum Medyczne - ENDOTERAPIA
• Romania
  • Bucuresti, Romania, 050098
    • Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie
  • Timis
    • Timisoara, Timis, Romania, 300002
      • Cabinet Particular Policlinic Algomed SRL
• Russian Federation
  • Moscow, Russian Federation, 129110
    • State budget Healthcare Institution Moscow regional scientific research clinical institute
  • Moscow, Russian Federation, 123423
    • Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"
  • Nizhniy Novgorod, Russian Federation, 603126
    • State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
  • Novosibirsk, Russian Federation, 630084
    • Municipal Budget Institution of Healthcare of Novosibirsk
  • Novosibirsk, Russian Federation, 630117
    • Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental
  • Novosibirsk, Russian Federation, 630117
    • FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"
  • Samara, Russian Federation, 443093
    • Limited Liability Company Medical Company "Hepatolog"
  • Samara, Russian Federation, 443093
    • Samara Diagnostic center, X-ray Department
  • Samara, Russian Federation, 443029
    • Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
  • Yaroslavl, Russian Federation, 150062
    • State budget institution of healthcare of Yaroslavl region Regional clinical hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
  • Kragujevac, Serbia, 34000
    • Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
  • Novi Sad, Serbia, 21000
    • Clinical Centre of Vojvodina Emergency Internal Medicine Division
  • Zrenjanin, Serbia, 23000
    • General Hospital Djordje Joanovic
  • Central Serbia
    • Belgrade, Central Serbia, Serbia, 11000
      • Military Medical Academy
• Slovakia
  • Bratislava, Slovakia, 85101
    • Medak s.r.o.
  • Nitra, Slovakia, 949 01
    • "KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra
  • Nove Mesto nad Vahom, Slovakia, 915 01
    • Poliklinika Libris, Synergy group, a.s.,
  • Presov, Slovakia, 080 01
    • Gastro I., s.r.o.
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2013
      • Chris Hani Baragwanath Academic hospital
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7500
      • Panorama Medi-Clinic
    • Cape Town, Western CAPE, South Africa, 7530
      • Louis Leipoldt Medical Centre
    • Cape Town, Western CAPE, South Africa, 7708
      • Dr JP Wright
    • Paarl, Western CAPE, South Africa, 7646
      • Endocare Research Centre
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08208
    • Corporacio Sanitaria Parc Tauli
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
  • Madrid,
    • Fuenlabrada, Madrid,, Spain, 28942
      • Hospital Universitario de Fuenlabrada
• Taiwan
  • Taipei City, Taiwan, 10002
    • National Taiwan University Hospital
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
  • Chernivtsi, Ukraine, 58001
    • Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'
  • Dnipropetrovsk, Ukraine, 49074
    • SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases
  • Kharkiv, Ukraine, 61037
    • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2
  • Kharkiv, Ukraine, 61039
    • State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"
  • Kyiv, Ukraine, 01030
    • Kyiv Municipal Clinical Hospital #18, Proctology Department
  • Lviv, Ukraine, 79019
    • LTD "St. Paraskeva Medical Center"
  • Lviv, Ukraine, 79059
    • Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
  • Odesa, Ukraine, 65025
    • Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department
  • Odesa, Ukraine, 65059
    • "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian
  • Uzhgorod, Ukraine, 88009
    • CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod
  • Vinnytsia, Ukraine, 21005
    • Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2
  • Zaporizhzhia, Ukraine, 69118
    • Minicipal Institution City Hospital #7, Therapeutic Department,
• United Kingdom
  • England
    • Bristol, England, United Kingdom, BS2 8HW
      • Bristol Royal Infirmary
    • Cambridge, England, United Kingdom, CB2 0QQ
      • Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • The North West London Hospitals NHS Trust
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich University Hospitals NHS Foundation Trust
  • W1t 7ha
    • London, W1t 7ha, United Kingdom
      • UCLH NIHR Clinical Research Facility
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Alabama Medical Group, P.C.
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Desert Sun Clinical Research, LLC
    • Tucson, Arizona, United States, 85710
      • Desert Sun Gastroenterology
    • Tucson, Arizona, United States, 85710
      • Desert Sun Surgery Center
  • California
    • La Jolla, California, United States, 92093
      • UCSD Medical Center
    • La Jolla, California, United States, 92037-0897
      • Altman Clinical and Translational Research Institute
    • La Jolla, California, United States, 92037
      • Perlman Medical Offices - UC San Diego Health System
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Surgery Center
    • Oceanside, California, United States, 92056
      • Alliance Clinical Research
    • Oceanside, California, United States, 92056
      • Center for Endoscopy- Covenant Surgical Partners
    • San Diego, California, United States, 92101
      • Sharp Rees-Stealy Medical Group, Inc.
    • San Diego, California, United States, 92123
      • Sharp Rees-Stealy Medical Group
    • San Diego, California, United States, 92103
      • Clinical Applications Laboratories, Inc
    • San Francisco, California, United States, 94115
      • UCSF Center for Colitis and Crohn's Disease
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Institute
    • Guilford, Connecticut, United States, 06437
      • Endoscopy Center of Connecticut, LLC
    • Hamden, Connecticut, United States, 06518
      • Medical Research Center of Connecticut, LLC
    • Hamden, Connecticut, United States, 06518
      • Gastroenterology Center of Connecticut, PC
    • Hamden, Connecticut, United States, 06518
      • Endoscopy Center of Connecticut, LLC
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • Florida
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Orange Park, Florida, United States, 32073
      • North Florida Gastroenterology Research, LLC
    • Orlando, Florida, United States, 32806
      • Internal Medicine Specialists
    • Orlando, Florida, United States, 32806
      • Citrus Ambulatory Surgery Center
    • Port Orange, Florida, United States, 32127
      • Advanced Medical Research Center
    • Port Orange, Florida, United States, 32127
      • Advanced Gastroenterology Center
    • Port Orange, Florida, United States, 32127
      • Endoscopy Center
    • Port Orange, Florida, United States, 32127
      • Port Orange Urgent Care
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, P.A.
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia, LLC
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialists, PC
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Clinical Research Center, Digestive Health
  • Maryland
    • Catonsville, Maryland, United States, 21228
      • Digestive Disease Associates, PA
    • Catonsville, Maryland, United States, 21228
      • Gastrointestinal Diagnostic Center
    • Chevy Chase, Maryland, United States, 20815
      • MGG Group Co., Inc., Chevy Chase Clinical Research
    • Columbia, Maryland, United States, 21044
      • Howard County GIDC
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health Systems
    • Ann Arbor, Michigan, United States, 48109-2701
      • East Ann Arbor Health and Geriatrics Center -UMHS
    • Ann Arbor, Michigan, United States, 48109-5872
      • Michigan Clinical Research Unit - UMHS
    • Ann Arbor, Michigan, United States, 48109
      • Medical Science Research Building 1 - UMHS
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
    • Troy, Michigan, United States, 48098
      • Surgical Centers of Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Huron Gastroenterology Associates - Center for Digestive Care
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Egg Harbor Township, New Jersey, United States, 08234
      • AGA Clinical Research Associates, LLC
    • Marlton, New Jersey, United States, 08053
      • South Jersey Gastroenterology, P.A.
    • Vineland, New Jersey, United States, 08360
      • The Gastroenterology Group of South Jersey
  • New York
    • Lake Success, New York, United States, 11042
      • NYU Langone Long Island Clinical Research Associates
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • New York, New York, United States, 10128
      • Kornbluth, Legnani, George MD, PC
    • New York, New York, United States, 10029
      • IBD Center - The Mount Sinai Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Carolina Research, Carolina Digestive Diseases
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology Research, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37212-1375
      • Vanderbilt University Medical Center
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine- Baylor Medical Center
    • Houston, Texas, United States, 77030
      • McGovern Medical School -The University of Texas Health Science Center at Houston
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Alpine Medical Group
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
    • Salt Lake City, Utah, United States, 84102
      • Salt Lake Regional Hospital
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
    • Richmond, Virginia, United States, 23298
      • VCU Health System Digestive Health Center
    • Richmond, Virginia, United States, 23298
      • VCU Health System Endoscopy Suite
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research - a division of GI Associates, LLC
    • Milwaukee, Wisconsin, United States, 53215
      • Center for Digestive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
• Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

• Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
• Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CP-690,550 5 mg BID; 5 mg BID	Drug: CP-690,550; 5 mg tablets, BID, for at least 12 months; Drug: CP-690,550; 10 mg tablets, BID, for at least 12 months
EXPERIMENTAL: CP-690,550 10 mg BID; 10 mg BID	Drug: CP-690,550; 5 mg tablets, BID, for at least 12 months; Drug: CP-690,550; 10 mg tablets, BID, for at least 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs)	Serious infections were treated infections that required parenteral antimicrobial therapy or hospitalization for treatment or; met other criteria that required the infection to be classified as a serious adverse event (SAE). SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Laboratory Test Abnormalities	Laboratory abnormalities: Hemoglobin, hematocrit, RBC: <0.8* LLN; reticulocytes (absolute [Abs], %): <0.5* LLN, >1.5* ULN; MCV, MCH: <0.9* LLN, >1.1* ULN; platelets:<0.5* LLN, >1.75* ULN; WBC:<0.6* LLN,>1.5* ULN; lymphocytes (Abs, %), total neutrophils (Abs,%):<0.8* LLN, >1.2* ULN; Basophils (Abs,%),eosinophils(Abs, %),monocytes(Abs, %):>1.2* ULN; total bilirubin,direct bilirubin,indirect bilirubin:>1.5* ULN; AST,ALT,gamma GT, LDH,ALP: >3.0* ULN; total protein,albumin: <0.8* LLN,>1.2* ULN: BUN,creatinine: >1.3* ULN;uric acid:>1.2* ULN; cholesterol,triglycerides: >1.3* ULN; cholesterol (HDL: <0.8* LLN; LDL: >1.2* ULN); sodium: <0.95* LLN, >1.05* ULN; potassium, chloride, calcium, bicarbonate: <0.9* LLN, >1.1* ULN; glucose: <0.6* LLN; creatine kinase >2.0* ULN; urine specific gravity: <1.003; urine pH: <4.5; urine (glucose,protein,blood,nitrite,leukocyte,esterase): >=1; Urine (RBC,WBC): >=20; urine epithelial cells:>=6; urine (casts,granular casts,hyaline casts): >1; urine bacteria:>20.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Vital Sign Abnormalities	Vital sign abnormalities included greater than or equal to (>=) 30 millimeter of mercury [mmHg] increase in systolic blood pressure (BP), >=30 mmHg decrease in systolic BP, Systolic BP (less than [<] 90 mmHg), >=20 mmHg increase in diastolic BP, >=20 mmHg decrease in diastolic BP, diastolic BP (<50 mmHg), pulse rate (<40 beats per minute [BPM]), pulse rate (greater than [>] 120 BPM).	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline	Physical examinations included weight, general appearance, head, ears, eyes, nose, mouth, throat, thyroid, skin (presence of rash), lungs (auscultation), heart (auscultation for presence of murmurs, gallops, rubs, peripheral edema), abdominal (palpation and auscultation), perianal, musculoskeletal, extremities, neurologic (mental status, gait, reflexes, motor and sensory function, coordination) and lymph nodes. Clinically significant changes were judged by the investigator.	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Number of Participants With Electrocardiogram (ECG) Abnormalities	ECG abnormalities criteria: maximum PR interval (>=300 millisecond); maximum QRS complex (>=200 millisecond); and maximum QT interval (>=500 millisecond).	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)
Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events	Incidence rates for adjudicated cardiovascular (major adverse cardiovascular event [MACE]), malignancy (non-melanoma skin cancer [NMSC], malignancies excluding NMSC, opportunistic infections (OIs) (both herpes zoster and non herpes zoster OIs) and thromboembolic (venous thromboembolism) safety events were analyzed. This outcome measure was measured in participants with events per 100 participants-years (pt with events/100 pts-yrs).	Baseline up to 28 days after last dose of study drug (up to 81 months for Tofacitinib 5 mg BID group and up to 85 months for Tofacitinib 10 mg BID group)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Remission at Months 2, 12, 24 and 36: Observed Cases	Remission in participants was defined as a total Mayo score of less than or equals to (<=) 2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and physician global assessment (PGA), each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Number of Participants in Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	Remission in participants was defined as a total Mayo score of <=2, with no individual sub score exceeding 1 point and a rectal bleeding sub score of 0. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Observed Cases	Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Number of Participants in Clinical Remission at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	Clinical remission in participants was defined as a total Mayo score of <=2 with no individual sub score exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total Mayo score range of 0 to 12, where higher score indicated more severe disease.	Months 2, 12, 24 and 36
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Observed Cases	PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.	Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Number of Participants in Partial Mayo Score (PMS) Remission at Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	PMS was an instrument designed to measure disease activity of UC without endoscopy. It consisted of 3 sub scores: stool frequency, rectal bleeding and PGA, each sub score graded from 0 to 3 with higher scores indicated higher disease severity. These sub scores were summed up to give a total PMS score range of 0 to 9, where higher score indicated more severe disease. PMS remission was defined as a partial Mayo score <=2 with no individual sub score >1.	Months 1, 4, 6, 9, 15, 18, 21, 27, 30, 33, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81 and 84
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Observed Cases	Mucosal healing in participants was defined as Mayo endoscopic sub score of 0 or 1. The Mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicated higher disease severity.	Months 2, 12, 24 and 36
Number of Participants Who Achieved Mucosal Healing at Months 2, 12, 24 and 36: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	Mucosal healing in participants was defined as mayo endoscopic sub score of 0 or 1. The mayo endoscopic sub score consisted of the findings of flexible sigmoidoscopy, graded from 0 to 3 with higher sub scores indicating higher disease severity.	Months 2, 12, 24 and 36
Number of Participants With Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score >=170 at Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84: Non-responder Imputation- Last Observation Carried Forward (NRI-LOCF)	IBDQ was a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease-specific quality of life in participants with inflammatory bowel disease (IBD), including ulcerative colitis consisted of 32 items scored from 1 (worst response) to 7 (best response). For each domain, higher score indicates better quality of life (QOL). Total IBDQ score was the sum of each item score, and ranged from 32 to 224 with a higher score indicated better QOL.	Months 2, 6, 12, 18, 24, 30, 36, 48, 60, 72 and 84

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.
• Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.
• Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
• Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
• Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.
• Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.
• Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.
• Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):27-41. doi: 10.1093/ibd/izac084.
• Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2022 Nov 7. doi: 10.1007/s40271-022-00603-w. Online ahead of print.
• Winthrop KL, Vermeire S, Long MD, Panes J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2023 Jan 5;29(1):85-96. doi: 10.1093/ibd/izac063.
• Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.
• Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan(R) Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.
• Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.
• Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panes J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.
• Biedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panes J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2022 Oct 15:izac222. doi: 10.1093/ibd/izac222. Online ahead of print.
• Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.
• Panes J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.
• Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.
• Sands BE, Armuzzi A, Marshall JK, Lindsay JO, Sandborn WJ, Danese S, Panes J, Bressler B, Colombel JF, Lawendy N, Maller E, Zhang H, Chan G, Salese L, Tsilkos K, Marren A, Su C. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther. 2020 Jan;51(2):271-280. doi: 10.1111/apt.15555. Epub 2019 Oct 29.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): August 6, 2020
• Study Completion (ACTUAL): August 6, 2020

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: November 9, 2011
• First Posted (ESTIMATE): November 11, 2011

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: open-label; Ulcerative colitis; long term treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921139; 2011-004581-14 (EUDRACT_NUMBER); OCTAVEOPEN (OTHER: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.