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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01470612
Recruitment Status : Active, not recruiting
First Posted : November 11, 2011
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: CP-690,550 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 946 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label Study Of Cp-690,550 In Subjects With Moderate To Severe Ulcerative Colitis
Actual Study Start Date : October 1, 2012
Estimated Primary Completion Date : July 27, 2018
Estimated Study Completion Date : July 27, 2018

Resource links provided by the National Library of Medicine


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

Experimental: CP-690,550 10 mg BID
10 mg BID
Drug: CP-690,550
10 mg tablets, BID, for at least 12 months




Primary Outcome Measures :
  1. Safety measured by the number of reported adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The proportion of subjects in remission. [ Time Frame: 12 months ]
  2. The proportion of subjects in partial Mayo score remission. [ Time Frame: 12 months ]
  3. The proportion of subjects who achieve mucosal healing. [ Time Frame: 12 months ]
  4. The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170. [ Time Frame: 12 months ]
  5. Number of subjects with serious infections. [ Time Frame: 12 months ]
  6. Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ]
  7. Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ]
  8. Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470612


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Locations
United States, Alabama
Alabama Medical Group, P.C.
Mobile, Alabama, United States, 36608
United States, Arizona
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
Desert Sun Gastroenterology
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center
Tucson, Arizona, United States, 85710
United States, California
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92037-0897
Investigational Drug Service Pharmacy
La Jolla, California, United States, 92037
Perlman Medical Offices - UC San Diego Health System
La Jolla, California, United States, 92037
UCSD Medical Center
La Jolla, California, United States, 92093
Cedars Sinai Medical Center -Thalians Bldg.
Los Angeles, California, United States, 90048
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Cedars Sinai Surgery Center
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center Inflammatory Bowel Disease Center
Los Angeles, California, United States, 90048
Alliance Clinical Research
Oceanside, California, United States, 92056
Center for Endoscopy- Covenant Surgical Partners
Oceanside, California, United States, 92056
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group
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
UCSF Endoscopy Unit at Mount Zion
San Francisco, California, United States, 94115
UCSF/Medical Center 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
Connecticut Clinical Research Institute
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
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Central Connecticut Endoscopy Center
Plainville, Connecticut, United States, 06062
United States, Florida
Gastroenterology Associates
Crystal River, Florida, United States, 34429
Suncoast Endoscopy Center
Inverness, Florida, United States, 34453
North Florida Gastroenterology Research, LLC
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center
Orlando, Florida, United States, 32806
Internal Medicine Specialists
Orlando, Florida, United States, 32806
Advanced Gatroenterology 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.
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center (COLONOSCOPY)
Alpharetta, Georgia, United States, 30005
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States, 30033
Emory University Hospital Midtown
Johns Creek, Georgia, United States, 30097
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States, 30024
United States, Kansas
Cotton-O'Neal Clinical Research Center Digestive Health
Topeka, Kansas, United States, 66606
United States, Maryland
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
Gastrointestinal Diagnostic Center
Catonsville, Maryland, United States, 21228
Chevy Chase Endoscopy Center
Chevy Chase, Maryland, United States, 20815
Metropolitan Gastroenterology Group, PC- Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
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 -UMHS
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems
Ann Arbor, Michigan, United States, 48109-5000
Michigan Clinical Research Unit - UMHS
Ann Arbor, Michigan, United States, 48109-5872
Medical Science Research Building 1 - UMHS
Ann Arbor, Michigan, United States, 48109
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Eastside Endoscopy Center
Macomb, Michigan, United States, 48044
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-Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
South Jersey Gastroenterology, P.A.
Marlton, New Jersey, United States, 08053
South Jersey Radiology Associates
Marlton, New Jersey, United States, 08053
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States, 08360
United States, New York
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates
Great Neck, New York, United States, 11021
The Private Practice of Simon Lichtiger, MD
New York, New York, United States, 10028
IBD Center - The Mount Siani Hospital
New York, New York, United States, 10029
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Colombia University Medical Center
New York, New York, United States, 10032
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
Great Lakes Gastroenterology
Mentor, Ohio, United States, 44060
Mentor Medical Campus
Mentor, Ohio, United States, 44060
The Endoscopy Center of Lake County
Mentor, Ohio, United States, 44060
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1375
GI Clinical Research
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Baylor College of Medicine - Baylor Medical Center
Houston, Texas, United States, 77030
Baylor College of Medicine- Baylor Medical Center
Houston, Texas, United States, 77030
Baylor St. Luke's Medical Center Endoscopy - McNair Campus
Houston, Texas, United States, 77030
Ertan Digestive Disease Center - Memorial Hermann Hospital
Houston, Texas, United States, 77030
McGovern Medical School -The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Digestive Health Specialists of Tyler
Tyler, Texas, United States, 75701
Trinity Mother Frances Endoscopy Center
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
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
Center for Digestive Health
Milwaukee, Wisconsin, United States, 53215
Wisconsin Center for Advanced Research - a division of GI Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Australia, Australian Capital Territory
The Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Liverpool Hospital eastern Campus
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Eastern Health-Box Hill Hospital 1
Box Hill, Victoria, Australia, 3128
Gastroenterology and Hepatology Unit, Monash Medical Centre
Clayton, Victoria, Australia, 3168
Austria
Landeskrankenhaus Innsbruck
Innsbruck, Austria, 6020
Krankenhaus Barmherzige Brueder St. Veit/Glan
St. Veit an der Glan, Austria, 9300
AKH Wien, Universitaetsklinik fuer Innere Medizin III
Wien, Austria, 1090
Belgium
GZA St Vincentius
Antwerpen, Belgium, 2018
AZ Groeninge
Kortrijk, Belgium, 8500
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
University Hospital Gasthuisberg
Leuven, Belgium, 3000
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg
Leuven, Belgium, 3000
H-Hartziekenhuis Roeselare-Menen vzw
Roeselare, Belgium, 8800
H.-Hart Ziekenhuis Roeselare-Menen vzw
Roeselare, Belgium, 8800
Brazil
Hospital de Clinicas de Porto Alegre - HCPA
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-003
Canada, Alberta
University of Calgary, Heritage Medical Research Clinic, TRW Building
Calgary, Alberta, Canada, T2N 4Z6
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 - MUHC
Montreal,, Quebec, Canada, H3G 1A4
Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny
Montreal, Quebec, Canada, H1T 2M4
Montreal General Hospital-McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada, S7K 0M7
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Instituto de Coloproctologia ICO S.A.S.
Medellin, Antioquia, Colombia, 00000
Croatia
University Hospital Center Zagreb
Zagreb, Croatia, 10 000
Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 500 12
Klinicke Centrum ISCARE I.V.F., Gastroenterologie
Praha 7, Czechia, 170 04
Nemocnice Strakonice, a.s., Interni oddeleni
Strakonice, Czechia, 386 29
Krajska Zdravotni, A.S.,
Usti Nad Labem, Czechia, 401 13
Denmark
Bispebjerg Hospital
Copenhagen, NV, Denmark, 2400
Aalborg Hospital
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus C, Denmark, 8000
Hvidovre Hospital
Hvidovre, Denmark, 2650
Odense University Hospital
Odense C, Denmark, 5000
Estonia
West Tallinn Central Hospital
Tallinn, Harjumaa, Estonia, 10617
ECG Unit, Innomedica OU and Qualitas AS (ECG Only)
Tallinn, Estonia, 10117
Innomedica OU
Tallinn, Estonia, 10117
West Tallinn Central Hospital Internal Diseases Clinic
Tallinn, Estonia, 10617
Mammograaf OU (Endoscopy Only)
Tallinn, Estonia, 13419
France
CHU Amiens-Picardie - Hopital Sud
Amiens Cedex 01, France, 80054
Hopital Beaujon, Gastroenterologie
Clichy, France, 92110
CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie
Nantes, France, 44093
Hopital Saint Antoine - Service de Gastroenterologie
Paris cedex 12, France, 75571
Hôpital Saint Louis - Service d'hepato-gastroenterologie
Paris, France, 75010
Hôpital Saint Louis
Paris, France, 75010
Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique
Pessac, France, 33604
CHU de Reims - Hopital Robert Debre
Reims cedex, France, 51092
Hopital Nord
St Priest En Jarez, France, 42270
Hopital Rangueil
Toulouse Cedex 9, France, 31059
Germany
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Schlewig Holstein, Germany, 24105
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit
Berlin, Germany, 13353
Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I
Halle, Germany, 06120
Hannover Medical School
Hannover, Germany, 30625
Medizinische Hochschule hannover
Hannover, Germany, 30625
Klinikum Lueneburg
Lueneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Germany, 32423
University Hospital Munich-Grosshadern
Munich, Germany, 81377
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Hungary
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.
Bekescsaba, Hungary, 5600
Pannonia Maganorvosi Centrum Kft.
Budapest, Hungary, 1136
Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály
Budapest, Hungary, H-1032
Peterfy Sandor utcai Korhaz
Budapest, Hungary, H-1076
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly
Budapest, Hungary, H-1125
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia
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 Gasztroenterologiai osztaly
Vac, Hungary, 2600
Javorszky Odon Korhaz
Vac, Hungary, 2600
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
The Edith Wolfson Medical Center/Gastroenterology Department
Holon, Israel, 58100
Rabin Medical Center, Beilinson campus
Petah Tikva, Israel, 49100
Italy
Istituto Clinico Humanitas IRCCS-IBD Center
Rozzano, Milano, Italy, 20089
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
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori, Japan, 036-8545
Toho University Medical Center Sakura Hospital
Sakura, Chiba, Japan, 285-8741
Toho University Sakura Medical Center
Sakura, Chiba, Japan, 285-8741
Kurume University Hospital
Kurume, Fukuoka, Japan, 830-0011
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital
Sapporo, Hokkaido, Japan, 060-0033
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 City University Hospital
Osaka-City, Osaka, Japan, 545-8586
Osaka Medical College Hospital
Takatsuki-shi, Osaka, Japan, 569-8686
Shiga University of Medical Science Hospital
Otsu, 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
Jikei University Hospital
Minato-ku, Tokyo, Japan, 105-8471
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, Japan, 108-8642
Keio University Hospital
Shinjuku-ku, Tokyo, Japan, 160-8582
Fukuoka University Chikushi Hospital
Fukuoka, Japan, 818-8502
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
The Hospital of Hyogo College of Medicine
Hyogo, Japan, 663-8501
Showa University Hospital
Tokyo, Japan, 142-8666
Korea, Republic of
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 11923
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Kyung Hee University Hospital
Seoul, Korea, Republic of, 02447
Severance Hospital, Yeonsei University Health System
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 06351
Seoul National University Hospital,
Seoul, Korea, Republic of, 110-744
Latvia
Digestive Diseases Center GASTRO
Riga, Latvia, LV-1006
ECG room, Clinic "Linezers"
Riga, Latvia, LV-1006
X-Ray Department, Clinic "Linezers"
Riga, Latvia, LV-1006
Netherlands
VU University Medical Center
Amsterdam, Netherlands, 1081 HV
Academic Medical Center (AMC)
Amsterdam, Netherlands, 1105 AZ
University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9713 GZ
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
New Zealand
Shakespeare Specialist Group
Milford, Auckland, New Zealand, 0620
Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School
Tauranga, BAY OF Plenty, New Zealand, 3112
Tauranga Hospital - Bay of Plenty Clinical School
Tauranga, BAY OF Plenty, New Zealand, 3143
Tauranga Hospital
Tauranga, BAY OF Plenty, New Zealand, 3143
Christchurch Hospital
Christchurch, Cantebury, New Zealand, 8011
Christchurch Hospital
Christchurch, Canterbury, New Zealand, 8011
Christchurch Hospital
Christchurch, Canterbury, New Zealand, 8140
Robarts Clinical Trials
London, Ontario, New Zealand, N6A5K8
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
Wellington, New Zealand, 6021
Poland
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.
Lodz, Iodzkie, Poland, 90-302
Centrum Endoskopii Zabiegowej
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Gabinet Lekarski - Janusz Rudzinski
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob
Warszawa, Mazowieckie, Poland, 02-507
Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital
Bialystok, Podlaskie, Poland, 15-950
H-T. Centrum Medyczne - ENDOTERAPIA
Tychy, Slaskie, Poland, 43-100
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego-
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
Cabinet Particular Policlinic Algomed SRL
Timisoara, Timis, Romania, 300002
Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie
Bucuresti, Romania, 050098
Russian Federation
"Federal state budget institution ""State scientific centre of coloproctology""
Moscow, Russian Federation, 123423
State budget Healthcare Institution Moscow regional scientific research clinical institute
Moscow, Russian Federation, 129110
State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.
Nizhniy Novgorod, Russian Federation, 603126
Municipal Budget Institution of Healthcare of Novosibirsk
Novosibirsk, Russian Federation, 630084
"Federal State Budgetary Institution ""Scientific Research Institute of Physiology and Fundamental
Novosibirsk, Russian Federation, 630117
FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"
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
Military Medical Academy
Belgrade, Central Serbia, Serbia, 11000
Clincial Centre of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology
Belgrade, Serbia, 11000
Clinical Centre of Kragujevac
Kragujevac, Serbia, 34000
Clinical Centre of Vojvodina
Novi Sad, Serbia, 21000
"General Hospital ""Djordje Joanovic"""
Zrenjanin, Serbia, 23000
Slovakia
Medak s.r.o.
Bratislava, Slovakia, 85101
"KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra
Nitra, Slovakia, 949 01
Poliklinika Libris, Synergy group, a.s.,
Nove Mesto nad Vahom, Slovakia, 915 01
Gastro L., s.r.o.
Presov, Slovakia, 080 01
South Africa
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa, 2013
Panorama Medi-Clinic
Cape Town, Western CAPE, South Africa, 7500
Louis Leipoldt Medical Centre
Cape Town, Western CAPE, South Africa, 7530
Dr JP Wright
Cape Town, Western CAPE, South Africa, 7708
Endocare Research Centre
Paarl, Western CAPE, South Africa, 7646
Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid,, Spain, 28942
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Corporacio Sanitaria Parc Tauli
Barcelona, Spain, 08208
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Hospital Clinico San Carlos
Madrid, Spain, 28040
Taiwan
National Taiwan University Hospital
Taipei City, Taiwan, 10002
Ukraine
Motor-Sich clinic, LLC
Zaporizhzhia, Ukrain, Ukraine, 69068
"Regional Municipal Institution ""Chernivtsi Regional Clinical Hospital"",
Chernivtsi, Ukraine, 58001
Bukovinian State Medical University/Chernivtsi Regional Clinical Hospital
Chernivtsi, Ukraine, 58001
Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'
Chernivtsi, Ukraine, 58001
Regional Municipal Institution Chernivtsi Regional Clinical Hospital
Chernivtsi, Ukraine, 58001
SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases
Dnipropetrovsk, Ukraine, 49074
Municipal Healthcare Institution 'Kharkiv City Clinical Hospital #2'
Kharkiv, Ukraine, 61037
State Institution "National L.T. Malaya Therapy Institute of National Academy of Medical Sciences 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
Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department
Odesa, Ukraine, 65025
"Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC
Odesa, Ukraine, 65059
"CI of Uzhgorod Regional Rada ""Uzhgorod Central Regional Hospital"",
Uzhgorod, Ukraine, 88009
"CI of Uzhgorod Regional Rada ""Uzhgorod Central Regional Hospital"". SHEI ""Uzhgorod National
Uzhgorod, Ukraine, 88009
Therapy Department. SHEI "Uzhgorod National University"Faculty of Postgraduate Education and
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War,
Vinnytsia, Ukraine, 21005
Minicipal Institution City Hospital #7, Therapeutic Department,
Zaporizhzhia, Ukraine, 69118
United Kingdom
Bristol Royal Infirmary
Bristol, England, United Kingdom, BS2 8HW
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 0QQ
NWLH NHS Trust, Northwick Park Hospital, Pharmacy Clinical Trials, Pharmacy Stores
Harrow, Middlesex, United Kingdom, HA1 3UJ
The North West London Hospitals NHS Trust
Harrow, Middlesex, United Kingdom, HA1 3UJ
Norfolk and Norwich University Hospitals NHS Foundation Trust.
Norwich, Norfolk, United Kingdom, NR4 7UY
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
UCLH NIHR Clinical Research Facility
London, W1t 7ha, United Kingdom
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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470612     History of Changes
Other Study ID Numbers: A3921139
2011-004581-14 ( EudraCT Number )
OCTAVEOPEN ( Other Identifier: Alias Study Number )
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018

Keywords provided by Pfizer:
Ulcerative colitis
open-label
long term treatment

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