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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01458574
First received: October 21, 2011
Last updated: August 16, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis
Drug: Placebo
Drug: CP690,550
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Oral CP-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The proportion of subjects in remission at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects with mucosal healing at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096 [ Time Frame: week 24 & 52 ] [ Designated as safety issue: No ]

Enrollment: 593
Study Start Date: July 2012
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458574

  Hide Study Locations
Locations
United States, Alabama
Internal Medicine Center, LLC
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital (Endoscopy Only)
Mobile, Alabama, United States, 36608
United States, California
UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center
La Jolla, California, United States, 92037-0845
UCSD Medical Center
La Jolla, California, United States, 92093
Alliance Clinical Research
Oceanside, California, United States, 92056
Desert Advanced Imaging
Palm Springs, California, United States, 92262
Erik Palmer, DO
Palm Springs, California, United States, 92262
Homan A Zadeh, MD, MPH
Palm Springs, California, United States, 92262
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States, 92101
Clinical Applications Laboratories, Inc
San Diego, California, United States, 92103
San Diego Endoscopy Center
San Diego, California, United States, 92103
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
Medical Center at Mount Zion
San Francisco, California, United States, 94115
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, United States, 94115
University of California San Francisco
San Francisco, California, United States, 94115
United States, Connecticut
Bristol Hospital
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Foundation
Bristol, Connecticut, United States, 06010
Endoscopy Center of Connecticut, LLC
Guilford, Connecticut, United States, 06437
Endoscopy Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
Gastroenterology Center of Connecticut, PC
Hamden, Connecticut, United States, 06518
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States, 06518
Central Connecticut Endoscopy Center
Plainville, Connecticut, United States, 06062
United States, Florida
Citrus Surgery & Endoscopy Center (colonoscopy)
Crystal River, Florida, United States, 34429
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Suncoast Endoscopy Center (colonoscopy)
Inverness, Florida, United States, 34453
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States, 32073
Orange Park Surgery Center
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center
Orlando, Florida, United States, 32806
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Advanced Gastroenterology Center
Port Orange, Florida, United States, 32127
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Endoscopy Center
Port Orange, Florida, United States, 32127
Port Orange Urgent Care
Port Orange, Florida, United States, 32127
Florida Medical Clinic, P.A.
Zephyhills, Florida, United States, 33542
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center (COLONOSCOPY)
Alpharetta, Georgia, United States, 30005
GI Consultants (COLONOSCOPY)
Atlanta, Georgia, United States, 30342
Emory Healthcare Heart Center (EKG)
Johns Creek, Georgia, United States, 30097
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Specialists
Suwanee, Georgia, United States, 30024
Johns Creek Diagnostic Center (XRAY)
Suwanee, Georgia, United States, 30024
United States, Kansas
Cotton-O'Neil Clinical Research - Digestive Health
Topeka, Kansas, United States, 66606
Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas, United States, 66606
United States, Maryland
Digestive Disease Associates, PA
Baltimore, Maryland, United States, 21229
Gastrointestinal Diagnostic Center
Baltimore, Maryland, United States, 21229
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
Howard County GIDC
Columbia, Maryland, United States, 21044
United States, Michigan
Saint Joseph Mercy Hospital - Inpatient Pharmacy
Ann Arbor, Michigan, United States, 48106
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-5000
Michigan Clinical Research Unit - Univeristy of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-5872
Medical Science Research Building 1 - University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Center for Digestive Health
Troy, Michigan, United States, 48098
Surgical Centers of Michigan
Troy, Michigan, United States, 48098
Michigan Heart SJMH
Ypsilanti, Michigan, United States, 48106
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States, 48197
Saint Joseph Mercy Hospital Outpatient Laboratory
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbour Township, New Jersey, United States, 08234
South Jersey Gastroenterology
Marlton, New Jersey, United States, 08053
The Endo Center at Voorhees
Vorhees, New Jersey, United States, 08043
United States, New York
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States, 11021
Present, Chapman, Marion, Steinlauf, Lichtiger MD, PC
New York, New York, United States, 10028
The Private Practice of Simon Lichtiger, MD
New York, New York, United States, 10028
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Mount Sinai School of Medicine Faculty Practice Associates
New York, New York, United States, 10029
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
CUMC Research Pharmacy
New York, New York, United States, 10032
Kornbluth, Legnani, George MD, PC
New York, New York, United States, 10128
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolina Research, Carolina Digestive Diseases
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195-0001
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States, 17604
United States, Texas
Professional Quality Research, Inc./Austin Gastroenterology PA
Austin, Texas, United States, 78705
Austin Endoscopy Center II
Austin, Texas, United States, 78745
Houston Hospital for Specialized Surgery (Endoscopy only)
Houston, Texas, United States, 77004
Baylor College of Medicine (Baylor Medical Center)
Houston, Texas, United States, 77030
Baylor College of Medicine - Baylor Medical Center (Drug Storage)
Houston, Texas, United States, 77030
Memorial Hermann Hospital - Ertan Digestive Disease Center
Houston, Texas, United States, 77030
The University of Texas at Houston Health Science Center
Houston, Texas, United States, 77030
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
United States, Utah
Alpine Medical Group
Salt Lake City, Utah, United States, 84102
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
Wasatch Endoscopy Center
Salt Lake City, Utah, United States, 84124
United States, Virginia
VCU Health System Digestive Health Center
Richmond, Virginia, United States, 23298
VCU Health System Endoscopy Suite
Richmond, Virginia, United States, 23298
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Liverpool Hospital Eastern Campus
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Eastern Health Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Australia
Liverpool Hospital
NSW, Australia, 2171
Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Wien, Vienna, Austria, 1090
AKH Wien Universitatsklinik fur Innere Medizin III
Wien, Austria, 1090
Belgium
GZA St. Vincentius
Antwerpen, Belgium, 2018
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, Belgium, 3000
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, Belgium, 8800
Brazil
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Canada, Alberta
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta - Zeidler Ledcor Centre
Edmonton, Alberta, Canada, T6G 2X8
Canada, Ontario
McMaster University Medical Center
Hamilton, Ontario, Canada, L8N 3Z5
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Instituto de Coloproctología ICO S.A.S.
Medellin, Antioquia, Colombia, 00000
Laboratorio Clinico y Reumatologico Reumalab
Medellin, Antioquia, Colombia
Quintiles, Ltd.
Marietta, GA, Colombia, 30067
Biomedical Systems
Brussels, Belgium, Colombia, 1160
Robarts Clinical Trials
London, Canada, Colombia
Croatia
University Hospital Center Zagreb
Zagreb, Croatia, 10 000
Czech Republic
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czech Republic, 500 12
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, Czech Republic, 386 29
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem
Usti nad Labem, Czech Republic, 40113
Denmark
Bispebjerg Hospital
Copenhagen, NV, Denmark, 2400
Aalborg Hospital
Aalborg, Denmark, 9000
Aalborg Hospital
Aalborg, Denmark, 9100
Aarhus University Hospital Department of Hepato Gastroenterrology V Aarhus
Aarhus C, Denmark, 8000
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense C, Denmark, 5000
Estonia
X-Ray Unit, East Tallinn Central Hospital
Tallinn, Estonia, 101 38
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Tallinn, Estonia, 10117
Innomedica OU
Tallinn, Estonia, 10117
East Tallinn Central Hospital Internal Medical Clinic
Tallinn, Estonia, 10138
ECG Unit of West Tallinn Central Hospital
Tallinn, Estonia, 10617
Internal Medicine Clinic
Tallinn, Estonia, 10617
X-Ray Department of West Tallinn Central Hospital
Tallinn, Estonia, 10617
Mammograaf OU (Endoscopy Only)
Tallinn, Estonia, 13419
ECG Unit, East Tallinn Central Hospital
Tallin, Estonia, 10138
France
CHU Amiens PICARDIE - Hopital SUD
Amiens Cedex 1, France, 80054
Hôpital Haut-Lévêque - Service pharmacie essais cliniques
Bordeaux, France, 33604
Hopital Beaujon
Clichy Cedex, France, 92110
Hotel-Dieu CHU Nantes
Nantes cedex 01, France, 44093
Hopital Saint Antoine - Service de Gastroenterologie
Paris cedex 12, France, 75571
Hopital Saint Louis - Service d'hepato-gastoenterologie
Paris, France, 75010
Hopital Saint Louis
Paris, France, 75010
C.H.U. de Reims - Hôpital Robert Debré
Reims cedex, France, 51092
Hopital Nord
Saint Priest en Jarez, France, 42270
Germany
Universitaetsklinikum Ulm
Ulm, Baden-wurttemberg, Germany, 89081
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, Germany, 24105
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum,
Berlin, Germany, 13353
Universitasklinikum Halle
Halle, Germany, 06120
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Klinikum Lüneburg/Abteilung Gastroenterologie
Lüneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Germany, 32423
Hungary
Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat
Bekescsaba, Hungary, 5600
Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont
Budapest, Hungary, 1076
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, Hungary, 1125
Szent Margit Korhaz - III Belgyogyaszat
Budapest, Hungary, H-1032
Pannonia Maganorvosi Centrum Kft.
Budapest, Hungary, H-1135
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek
Debrecen, Hungary, 4032
Bekes Megyei Pandy Kalman Korhaz III. Gasztroenterologiai Osztaly
Gyula, Hungary, 5700
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, Hungary, 3526
Karolina Korhaz
Mosonmagyarovar, Hungary, 9200
Pecsi Tudomanyegyetem Klinikai Kozpont
Pecs, Hungary, 7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika
Szeged, Hungary, 6720
Javorszky Odon Korhaz
Vac, Hungary, 2600
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Rabin Medical Center, Beilinson campus
Petah Tikva, Israel, 49100
Kaplan Medical Center
Rehovot, Israel, 76100
Italy
Istituto Clinico Humanitas IRCSS
Rozzano, Milano, Italy, 20089
AOU Mater Domini
Catanzaro, Milan, Italy, 88100
AOR Villa Sofia-Cervello
Palermo, PA, Italy, 90146
AOU Mater Domini - U.O. Fisiopatologia Digestiva
Catanzaro, Italy, 88100
Japan
Aichi Medical University Hospital
Nagakute, Aichi, Japan, 480-1195
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan, 060-0033
The Hospital of Hyogo College of Medicine
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Mito Medical Center
Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
Sameshima Hospital
Kagoshima-shi, Kagoshima, Japan, 892-0846
Kuniyoshi Hospital
Kochi-shi, Kochi, Japan, 780-0901
National Hospital Organization Sendai Medical Center
Sendai, Miyagi, Japan, 983-8520
Osaka Medical College Hospital
Takatsuki-shi, Osaka, Japan, 569-8686
Shiga University of Medical Science Hospital
Otsu-shi, Shiga, Japan, 520-2192
Tokyo Medical And Dental University Hospital, Faculty of Medicine
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokai University Hachioji Hospital
Hachioji, Tokyo, Japan, 192-0032
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan, 108-8642
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan, 141-8625
Showa University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Chiba University Hospital
Chiba, Japan, 260-8677
Toho University Sakura Medical Center
Chiba, Japan, 285-8741
Kurume University Hospital
Fukuoka, Japan, 830-0011
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Osaka City University Hospital
Osaka, Japan, 545-8586
Korea, Republic of
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Kyung Hee University Hospital, Clinical Laboratory
Dongdaemun-gu, Seoul, Korea, Republic of, 130-872
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital,
Seoul, Korea, Republic of, 110-744
Kyung Hee University Hospital / Department of Gastroenterology
Seoul, Korea, Republic of, 130-872
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Latvia
ECG room Clinic Linezers (ECG only) Riga East University Hospital
Riga, Latvia, LV-1006
X-Ray Department, Clinic Linezers (radiology only)
Riga, Latvia, LV-1006
Digestive Diseases Center GASTRO
Riga, Latvia, LV1006
Netherlands
Leiden University Medical Center (LUMC)
Leiden, ZH, Netherlands, 2333 ZA
VU University Medical Center (VUMC)
Amsterdam, Netherlands, 1081 HV
Academic Medical Centre
Amsterdam, Netherlands, 1105 AZ
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9713 GZ
New Zealand
Shakespeare Specialist Group
Milford, Auckland, New Zealand, 0620
Tauranga Hospital
Tauranga, Bay of Plenty, New Zealand, 3143
Christchurch Hospital
Christchurch, Canterbury Region, New Zealand, 8011
Auckland City Hospital
Auckland, New Zealand, 1023
Southern District Health Board
Dunedin, New Zealand, 9016
Waikato Hospital
Hamilton, New Zealand, 3240
P3 Research Limited
Wellington, New Zealand, 6021
Pacific Radiology (X-rays only)
Wellington, New Zealand, 6021
Bowen Hospital
Wellington, New Zealand, 6035
Poland
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Lodz, Iodzkie, Poland, 90-302
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Gabinet Lekarski - Janusz Rudzinski
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Klinika Chorob Wewnetrznych i Gastroenterologii z
Warszawa, Mazowieckie, Poland, 02-507
H-T. Centrum Medyczne - ENDOTERAPIA
Tychy, Slaskie, Poland, 43-100
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital
Lodz, Poland, 90-153
Endoskopia Sp. Z O.O.
Sopot, Poland, 81-756
Nzoz Vivamed
Warszawa, Poland, 03-580
Lexmedica
Wroclaw, Poland, 53-114
Romania
Spitalul Universitar de Urgenta Bucuresti, Sectia De Medicina Intema II si Gastroenterologie
Bucuresti, Sector 5, Romania, 050098
Cabinet Particular Policlinic Algomed Srl
Timisoara, Timis, Romania, 300002
Russian Federation
Municipal Institution of Healthcare City Clinical Hospital 12,
Saratov, Russia, Russian Federation, 410039
Federal state budget institution "State scientific centre of coloproctology"
Moscow, Russian Federation, 123423
State Budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
Nizhniy Novgorod, Russian Federation, 603126
Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency",
Novosibirsk,, Russian Federation, 630068
Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12"
Novosibirsk, Russian Federation, 630084
State Budget Educational Institution of Higher Professional Education
Novosibirsk, Russian Federation, 630091
Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental
Novosibirsk, Russian Federation, 630117
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"
Samara, Russian Federation, 443029
Limited Liability Company Medical Company "Hepatolog"
Samara, Russian Federation, 443093
Samara Diagnostic center, X-ray Department
Samara, Russian Federation, 443093
State budget institution of healthcare of Yaroslavl region Regional clinical hospital
Yaroslavl, Russian Federation, 150062
Serbia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, Serbia, Europe, Serbia, 11000
Clinical Hospital Centre Zvezdara
Belgrade, Serbia, 11000
Military Medical Academy Belgrade
Belgrade, Serbia, 11000
Clinical Centre of Kragujevac
Kragujevac, Serbia, 34000
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology
Novi Sad, Serbia, 21000
Clinical Centre of Vojvodina, Emergency Internal Medicine Division
Novi Sad, Serbia, 21000
Slovakia
Medak s.r.o.
Bratislava, Slovakia, 851 01
KM Management spol. s.r.o.
Nitra, Slovakia, 949 01
Aura SA, s.r.o.
Nove Mesto nad Vahom, Slovakia, 91501
Gastro I., s.r.o.
Presov, Slovakia
South Africa
Dr John Philip Wright
Claremon, Cape Town Western Cape, South Africa, 7708
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa, 2013
Panorama MediClinic
Cape Town, Western Cape, South Africa, 7500
The Loius Leipoldt Medical Centre Alida Thorpe
Cape Town, Western Cape, South Africa, 7530
Endocare Research Centre
Western Cape, South Africa, 7646
Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 10002
Ukraine
Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community"
Simferopol, Ar Krym, Ukraine, 95017
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, Ukraine, 58001
Regional Municipal Institution ¿Chernivtsi Regional Clinical Hospital¿,
Chernivtsi, Ukraine, 58001
State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of
Dniepropetrovsk, Ukraine, 49074
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department
Kharkiv, Ukraine, 61037
State Institution "National L.T. Malaya Therapy Institute of National Academy of
Kharkov, Ukraine, 61039
Kyiv Municipal Clinical Hospital #18, Proctology Department
Kyiv, Ukraine, 01030
LTD "St. Paraskeva Medical Center"
Lviv, Ukraine, 79019
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,
Lviv, Ukraine, 79059
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department,
Odesa, Ukraine, 65010
Municipal Institution "Odesa Regional Clinical Hospital"
Odesa, Ukraine, 65025
SI "Railway Hospital of the State Institution "Odesa Railway" Odesa National Medical University,
Odessa, Ukraine, 65010
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat.
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2,
Vinnytsia, Ukraine, 21005
Motor-Sich clinic, LLC
Zaporizhzhia, Ukraine, 69068
Minicipal Institution City Hospital 7, Therapevtic Department,
Zaporizhzhia, Ukraine, 69118
United Kingdom
Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
Department of Gastroenterology, Old Building
Bristol, England, United Kingdom, BS2 8HW
University College Hospital
London, Greater London, United Kingdom, NW1 2BU
NWLH NHS trust
Harrow, Middlesex, United Kingdom, HA1 3UJ
The North West London Hospitals NHS Trust
Harrow, Middlesex, United Kingdom, HA1 3UJ
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 0QQ
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458574     History of Changes
Other Study ID Numbers: A3921096  2011-004580-79  OCTAVESUSTAIN 
Study First Received: October 21, 2011
Last Updated: August 16, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Janus kinase inhibitor
JAK 3 inhibitor
inflammatory bowel disease
ulcerative colitis
OCTAVE
CP-690
550
tofacitinib
Xeljanz

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

ClinicalTrials.gov processed this record on August 30, 2016