A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis (OCTAVE)

April 7, 2017 updated by: Pfizer

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

593

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health-Box Hill Hospital
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
  • Austria
    • Vienna
      • Wien, Vienna, 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
      • 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, H3G 1A4
        • Montreal General Hospital - McGill University Health 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
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 12
        • Hepato-Gastroenterologie HK, s.r.o.
      • Strakonice, Czech Republic, 386 29
        • Nemocnice Strakonice, a.s., Interni oddeleni
      • Usti nad Labem, Czech Republic, 40113
        • Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Hospital
      • Aarhus C, Denmark, 8000
        • Aarhus University Hospital
      • Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital
      • Hvidovre, Denmark, 2650
        • Hvidovre Hospital
      • Odense C, Denmark, 5000
        • Odense University Hospital
  • Estonia
      • Tallin, Estonia, 10138
        • ECG Unit, East Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
      • Tallinn, Estonia, 10117
        • Innomedica OÜ
      • Tallinn, Estonia, 10617
        • ECG Unit of West Tallinn Central Hospital
      • Tallinn, Estonia, 10617
        • X-Ray Department of West Tallinn Central Hospital
      • Tallinn, Estonia, 10117
        • ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
      • Tallinn, Estonia, 13419
        • Mammograaf OU (Endoscopy Only)
      • Tallinn, Estonia, 101 38
        • X-Ray Unit, East Tallinn Central Hospital
      • Tallinn, Estonia, 10138
        • East Tallinn Central Hospital Internal Medical Clinic
      • Tallinn, Estonia, 10617
        • X- Ray Department of West Tallinn Central Hospital
  • France
      • Amiens Cedex 1, France, 80054
        • Chu Amiens Picardie - Hopital Sud
      • Bordeaux cedex, France, 33075
        • Hopital Saint André
      • Clichy Cedex, France, 92110
        • Hôpital Beaujon
      • Nantes cedex 01, France, 44093
        • Hotel-Dieu CHU Nantes
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75010
        • Hopital Saint Louis - Service d'hepato-gastoenterologie
      • Paris cedex 12, France, 75571
        • Hopital Saint Antoine - Service de Gastroenterologie
      • Reims cedex, France, 51092
        • C.H.U. de Reims - Hôpital Robert Debré
      • Saint Priest en Jarez, France, 42270
        • Hopital Nord
  • Germany
      • Berlin, Germany, 13353
        • Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
      • Halle, Germany, 06120
        • Universitatsklinikum Halle
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Lüneburg, Germany, 21339
        • Klinikum Lüneburg/Abteilung Gastroenterologie
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
    • Schlewig Holstein
      • Kiel, Schlewig Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat
      • Budapest, Hungary, 1125
        • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
      • Budapest, Hungary, H-1135
        • Pannonia Maganorvosi Centrum Kft.
      • Budapest, Hungary, 1032
        • Szent Margit Korhaz - III Belgyogyaszat
      • Budapest, Hungary, 1076
        • Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek
      • Gyula, Hungary, 5700
        • Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
      • Mosonmagyarovar, Hungary, 9200
        • Karolina Korhaz
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. sz. Belgyogyaszati Klinika
      • Vac, Hungary, 2600
        • Jávorszky Ödön Kórház
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center, Beilinson campus
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
  • Italy
      • Catanzaro, Italy, 88100
        • AOU Mater Domini - U.O. Fisiopatologia Digestiva
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas IRCSS
    • PA
      • Palermo, PA, Italy, 90146
        • AOR Villa Sofia-Cervello
  • Japan
      • Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center
      • Fukuoka, Japan, 830-0011
        • Kurume University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
    • Aichi
      • Nagakute, Aichi, Japan, 480-1195
        • Aichi Medical University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
        • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • The Hospital of Hyogo College of Medicine
    • 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
      • Takatsuki-shi, Osaka, Japan, 569-8686
        • Osaka Medical College Hospital
    • Shiga
      • Otsu-shi, 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, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Showa University Hospital
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Ntt Medical Center Tokyo
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center
      • Seoul, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital,
    • Gyeonggi-do
      • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
        • Hanyang University Guri Hospital
    • Republic of Korea
      • Seoul, Republic of Korea, Korea, Republic of, 130-872
        • Kyunghee University Hospital
  • Latvia
      • Riga, Latvia, LV-1006
        • ECG room Clinic Linezers (ECG only) Riga East University Hospital
      • Riga, Latvia, LV-1006
        • X-Ray Department, Clinic Linezers (radiology only)
      • Riga, Latvia, LV1006
        • Digestive Diseases Center GASTRO
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Centre
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center (VUMC)
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen (UMCG)
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center (LUMC)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Dunedin, New Zealand, 9016
        • Southern District Health Board
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Wellington, New Zealand, 6021
        • P3 Research Limited
      • Wellington, New Zealand, 6021
        • Pacific Radiology (X-rays only)
      • Wellington, New Zealand, 6035
        • Bowen Hospital
    • Auckland
      • Milford, Auckland, New Zealand, 0620
        • Shakespeare Specialist Group
    • Bay of Plenty
      • Tauranga, Bay of Plenty, New Zealand, 3143
        • Tauranga Hospital
    • Canterbury Region
      • Christchurch, Canterbury Region, New Zealand, 8011
        • Christchurch Hospital
  • Poland
      • Bydgoszcz, Poland, 85-681
        • Gabinet Lekarski - Janusz Rudzinski
      • Krakow, Poland, 31-009
        • Gabinet Endoskopii Przewodu Pokarmowego
      • Lodz, Poland, 90-153
        • Oddzial Kliniczny Gastroenterologii Ogólnej i Onkologicznej, Uniwersytecki Szpital
      • 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, 85-168
        • Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-507
        • Klinika Chorob Wewnetrznych i Gastroenterologii z
    • Slaskie
      • Tychy, Slaskie, Poland, 43-100
        • H-T. Centrum Medyczne - ENDOTERAPIA
  • Romania
      • Bucuresti, Romania, 050098
        • Spitalul Universitar de Urgenta Bucharest
    • Timis
      • Timisoara, Timis, Romania, 300002
        • Cabinet Particular Policlinic Algomed SRL
  • Russian Federation
      • Moscow, Russian Federation, 123423
        • Federal state budget institution "State scientific centre of coloproctology"
      • Nizhniy Novgorod, Russian Federation, 603126
        • State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
      • Novosibirsk, Russian Federation, 630091
        • State Budget Educational Institution of Higher Professional Education
      • Novosibirsk, Russian Federation, 630084
        • Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"
      • Novosibirsk, Russian Federation, 630117
        • Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental
      • Novosibirsk,, Russian Federation, 630068
        • Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",
      • 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"
      • Samara, Russian Federation, 443063
        • Limited Liability Company Medical Company "Hepatolog"
      • Yaroslavl, Russian Federation, 150062
        • State budget institution of healthcare of Yaroslavl region Regional clinical hospital
    • Russia
      • Saratov, Russia, Russian Federation, 410039
        • Municipal Institution of Healthcare City Clinical Hospital 12,
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Centre Zvezdara
      • Belgrade, Serbia, 11000
        • Military Medical Academy Belgrade
      • Kragujevac, Serbia, 34000
        • Clinical Centre of Kragujevac
      • 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""
    • Serbia, Europe
      • Belgrade, Serbia, Europe, Serbia, 11000
        • Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Medak s.r.o.
      • Nitra, Slovakia, 949 01
        • KM Management spol. s.r.o.
      • Nove Mesto nad Vahom, Slovakia, 91501
        • Aura SA, s.r.o.
      • Presov, Slovakia, 080 01
        • GASTRO I., s.r.o.
  • South Africa
      • Western Cape, South Africa, 7646
        • Endocare Research Centre
    • Cape Town
      • Claremont, Cape Town, South Africa, 7708
        • Dr John Philip Wright
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2013
        • Chris Hani Baragwanath Academic Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
        • Louis Leipoldt Medical Centre
      • Cape Town, Western Cape, South Africa, 7500
        • Panorama MediClinic
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínic I Provincial de Barcelona
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge, Servicio de Digestivo
  • 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,
      • Dniepropetrovsk, Ukraine, 49074
        • State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of
      • Kharkiv, Ukraine, 61037
        • Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
      • Kharkiv, Ukraine, 61039
        • State Institution "National L.T. Malaya Therapy Institute of National Academy of
      • 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, 65010
        • SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
      • Odesa, Ukraine, 65025
        • Municipal Institution "Odesa Regional Clinical Hospital"
      • Uzhgorod, Ukraine, 88009
        • SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,
      • Zaporizhzhia, Ukraine, 69068
        • Motor-Sich clinic, LLC
      • Zaporizhzhia, Ukraine, 69118
        • Minicipal Institution City Hospital 7, Therapevtic Department,
      • Zaporizhzhia, Ukraine, 69118
        • Municipal Institution "City Hospital #7", Zaporizhzhia State Medical University
    • Ar Krym
      • Simferopol, Ar Krym, Ukraine, 95017
        • Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB20QQ
        • Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust
    • England
      • Bristol, England, United Kingdom, BS2 8HW
        • Department of Gastroenterology, Old Building
    • Greater London
      • London, Greater London, United Kingdom, NW1 2BU
        • University College Hospital
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • The North West London Hospitals NHS Trust
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • NWLH NHS trust
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Internal Medicine Center, LLC
      • Mobile, Alabama, United States, 36608
        • Springhill Memorial Hospital (Endoscopy Only)
    • California
      • La Jolla, California, United States, 92093
        • UCSD Medical Center
      • La Jolla, California, United States, 92037-0845
        • UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center
      • Oceanside, California, United States, 92056
        • Alliance Clinical Research
      • Palm Springs, California, United States, 92262
        • Desert Advanced Imaging
      • Palm Springs, California, United States, 92262
        • Erik Palmer, DO
      • Palm Springs, California, United States, 92262
        • Homan A Zadeh, MD, MPH
      • Rancho Mirage, California, United States, 92270
        • Hope Square Surgical Center
      • 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
        • San Diego Endoscopy Center
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc
      • San Francisco, California, United States, 94115
        • University of California San Francisco
      • San Francisco, California, United States, 94115
        • UCSF Endoscopy Unit at Mount Zion
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Connecticut Clinical Research Foundation
      • Bristol, Connecticut, United States, 06010
        • Bristol Hospital
      • 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
      • Plainville, Connecticut, United States, 06062
        • Central Connecticut Endoscopy Center
    • Florida
      • Crystal River, Florida, United States, 34429
        • Citrus Surgery & Endoscopy Center (colonoscopy)
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Inverness, Florida, United States, 34453
        • Suncoast Endoscopy Center (colonoscopy)
      • 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
      • Zephyhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Alpharetta, Georgia, United States, 30005
        • Georgia Endoscopy Center
      • Atlanta, Georgia, United States, 30342
        • GI Consultants
      • Johns Creek, Georgia, United States, 30097
        • Emory Healthcare Heart Center
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates Of Central Georgia, LLC
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialists, PC
      • Suwanee, Georgia, United States, 30024
        • Johns Creek Diagnostic Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neal Clinical Research Center Digestive Health
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates, PA
      • Baltimore, Maryland, United States, 21229
        • Gastrointestinal Diagnostic Center
      • Catonsville, Maryland, United States, 21228
        • Digestive Disease Associates, PA
      • Columbia, Maryland, United States, 21044
        • Howard County GIDC
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • University of Michigan Health Systems
      • Ann Arbor, Michigan, United States, 48109-5872
        • Michigan Clinical Research Unit - UMHS
      • Ann Arbor, Michigan, United States, 48109
        • Medical Science Research Building 1 - UMHS
      • Ann Arbor, Michigan, United States, 48106
        • Saint Joseph Mercy Hospital - Inpatient Pharmacy
      • Ann Arbor, Michigan, United States, 48109-2701
        • East Ann Arbor Health and Geriatrics Center - 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
      • Utica, Michigan, United States, 48317
        • Utica Surgery Center (Endoscopy Only)
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
      • Ypsilanti, Michigan, United States, 48106
        • Michigan Heart SJMH
      • Ypsilanti, Michigan, United States, 48197
        • Saint Joseph Mercy Hospital Outpatient Laboratory
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Egg Harbour Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
      • Marlton, New Jersey, United States, 08053
        • South Jersey Gastroenterology
      • Vorhees, New Jersey, United States, 08043
        • The Endo Center at Voorhees
    • New York
      • Great Neck, New York, United States, 11021
        • NYU Langone Long Island Clinical Research Associates
      • Great Neck, New York, United States, 11021
        • NYU Langone Nassau Gastroenterology Associates
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10028
        • The Private Practice of Simon Lichtiger, MD
      • New York, New York, United States, 10032
        • CUMC Research Pharmacy
      • 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, 44195-0001
        • Cleveland Clinic
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology
      • Mentor, Ohio, United States, 44060
        • The Endoscopy Center of Lake County
      • Mentor, Ohio, United States, 44060
        • Mentor Medical Campus
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterology Associates of Lancaster, Ltd.
    • Texas
      • Austin, Texas, United States, 78745
        • Austin Gastroenterology PA
      • Austin, Texas, United States, 78705
        • Professional Quality Research, Inc.- Austin Gastroenterology PA
      • Austin, Texas, United States, 78745
        • Austin Endoscopy Center II
      • 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
        • Baylor College of Medicine - Baylor Medical Center (Drug Storage)
      • Houston, Texas, United States, 77030
        • McGovern Medical School -The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77004
        • Houston Hospital for Specialized Surgery (Endoscopy only)
      • Tyler, Texas, United States, 75701
        • Digestive Health Specialists of Tyler
    • 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, 84124
        • Wasatch Endoscopy Center
    • 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
      • Milwaukee, Wisconsin, United States, 53215
        • The Center for Digestive Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 met study entry criteria and completed 8-week induction treatment from Study A3921094 or A3921095
  • Subjects who achieved clinical response in Study A3921094 or A3921095
  • Women of childbearing potential must test negative for pregnancy prior to study enrollment
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator
Drug: Placebo
Placebo 10 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 5 mg Arm
Drug: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 10 mg Arm
Drug: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants In Remission at Week 52
Time Frame: Week 52
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 was 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 sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12 where higher score indicating higher disease severity.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Mucosal Healing at Week 52
Time Frame: Week 52
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 sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Week 52
Percentage of Participants With Sustained Steroid-Free Remission (Defined as Being in Remission and Steroid-Free at Both Week 24 and 52), Among Participants With Remission at Baseline
Time Frame: Week 24, 52
Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission (among participants with remission at baseline) were reported in this outcome measure.
Week 24, 52
Percentage of Participants in Remission at Week 24
Time Frame: Week 24
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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24
Percentage of Participants in Sustained Remission
Time Frame: Week 24, 52
Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher subscores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Week 24, 52
Percentage of Participants With Mucosal Healing at Week 24
Time Frame: Week 24
Mucosal healing in participants was defined by a mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Week 24
Percentage of Participants With Sustained Mucosal Healing
Time Frame: Week 24, 52
Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants With Mucosal Healing at Week 24 and 52, Among Participants With Mucosal Healing at Baseline
Time Frame: Week 24, 52
Mucosal healing in participants was defined as achieving mayo endoscopic subscore of 0 or 1. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants With Sustained Mucosal Healing, Among Participants With Mucosal Healing at Baseline
Time Frame: Week 24, 52
Sustained mucosal healing in participants was defined by achieving mayo endoscopic subscore of 0 or 1 at both Week 24 and Week 52. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants With Clinical Response at Week 24 and 52
Time Frame: Week 24, 52
Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in Mayo score of at least 3 points and at least 30%, 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with clinical response at Week 24 and 52 have been reported in this outcome measure.
Week 24, 52
Percentage of Participants With Sustained Clinical Response
Time Frame: Week 24, 52
Sustained clinical response in participants was defined as showing clinical response at both Week 24 and Week 52. Clinical response was defined by a decrease from induction study (A3921094 [NCT01465763] or A3921095 [NCT01458951]) baseline in mayo score of at least 3 points and at least 30%, 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained clinical response are reported in this outcome measure.
Week 24, 52
Percentage of Participants in Clinical Remission at Week 24 and 52
Time Frame: Week 24, 52
Clinical remission in participants was defined as a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Sustained Clinical Remission
Time Frame: Week 24, 52
Sustained clinical remission in participants was defined as being in clinical remission at both Week 24 and Week 52. Clinical remission was defined by a total mayo score of 2 points or lower, with no individual subscore exceeding 1 point. Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Deep Remission at Week 24 and 52
Time Frame: Week 24, 52
Deep remission in participants was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Sustained Deep Remission
Time Frame: Week 24, 52
Sustained deep remission was defined by being in deep remission at both Week 24 and Week 52. Deep remission in participants was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Symptomatic Remission at Week 24 and 52
Time Frame: Week 24, 52
Symptomatic remission in participants was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 sub-scores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Sustained Symptomatic Remission
Time Frame: Week 24, 52
Sustained symptomatic remission in participants was defined as being in symptomatic remission at both Week 24 and Week 52. Symptomatic remission was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Endoscopic Remission at Week 24 and 52
Time Frame: Week 24, 52
Endoscopic remission in participants was defined as a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Week 24, 52
Percentage of Participants in Sustained Endoscopic Remission
Time Frame: Week 24, 52
Sustained endoscopic remission in participants was defined as being in endoscopic remission at both Week 24 and Week 52. Endoscopic remission was defined by a mayo endoscopic subscore of 0. The mayo endoscopic subscore consisted of the findings of centrally read flexible sigmoidoscopy, graded from 0 to 3 with higher subscores indicating higher disease severity.
Week 24, 52
Total Mayo Score at Baseline, Week 24 and 52
Time Frame: Baseline, Week 24, 52
Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity.
Baseline, Week 24, 52
Change From Baseline in Total Mayo Score at Week 24 and 52
Time Frame: Baseline, Week 24, 52
Mayo score was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Change from baseline in total mayo score at Week 24 and 52 was reported.
Baseline, Week 24, 52
Percentage of Participants in Remission, Among Participants With Remission at Baseline
Time Frame: Week 24, 52
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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Week 24, 52
Percentage of Participants in Sustained Remission, Among Participants With Remission at Baseline
Time Frame: Week 24, 52
Sustained remission in participants was defined by being in remission at both Week 24 and Week 52. Remission was defined as 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher score indicating higher disease severity.
Week 24, 52
Percentage of Participants in Steroid-free Remission, Among Participants in Remission at Baseline
Time Frame: Week 24, 52
Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants in steroid-free remission were reported in this outcome measure.
Week 24, 52
Percentage of Participants in Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Time Frame: Week 24, 52
Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with steroid-free remission were reported in this outcome measure.
Week 24, 52
Percentage of Participants in Sustained Steroid-Free Remission, Among Participants Receiving Steroids at Baseline
Time Frame: Week 24, 52
Sustained steroid-free remission was defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid-free remission was defined by being in remission, in addition to no requirement of any treatment with steroid for at least 4 weeks prior to the visit. Remission 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 was an instrument designed to measure disease activity of UC. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible sigmoidoscopy and PGA, each graded from 0 to 3 with higher scores indicating higher disease severity. These subscores were summed up to give a total score range of 0 to 12, where higher scores indicating higher disease severity. Percentage of participants with sustained steroid-free remission were reported in this outcome measure.
Week 24, 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2012

Primary Completion (Actual)

May 27, 2016

Study Completion (Actual)

May 27, 2016

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921096
  • 2011-004580-79 (EudraCT Number)
  • OCTAVESUSTAIN (Other Identifier: Alias Study Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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