Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470612
First received: October 21, 2011
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Ulcerative Colitis
Drug: CP-690,550
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety measured by the number of reported adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The proportion of subjects in remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects in partial Mayo score remission. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects who achieve mucosal healing. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • The proportion of subjects with total score in Inflammatory Bowel Disease Questionnaire greater than or equal to 170. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of subjects with serious infections. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with adjudicated cardiovascular events. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over read. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with addition of lipid lowering agents. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 900
Study Start Date: October 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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.
  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: NCT01470612

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Alabama
Surgicare of Mobile Recruiting
Mobile, Alabama, United States, 36606
United States, Arizona
Desert Sun Clinical Research, LLC Active, not recruiting
Tucson, Arizona, United States, 85710
Desert Sun Gastroenterology Active, not recruiting
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center Active, not recruiting
Tucson, Arizona, United States, 85710
United States, California
Investigational Drug Service Pharmacy Recruiting
La Jolla, California, United States, 92093
UCSD Medical Center Recruiting
La Jolla, California, United States, 92093
Cedars Sinai Medical Center -Thalians Bldg. Recruiting
Los Angeles, California, United States, 90048
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Cedars Sinai Surgery Center Recruiting
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
Alliance Clinical Research Recruiting
Oceanside, California, United States, 92056
Sharp Rees-Stealy Medical Group Active, not recruiting
San Diego, California, United States, 92101
Clinical Applications Laboratories, Inc. Recruiting
San Diego, California, United States, 92103
San Diego Endoscopy Center (Endoscopy Only) Recruiting
San Diego, California, United States, 92103
Sharp Rees-Stealy Medical Group Active, not recruiting
San Diego, California, United States, 92123
UCSF Endoscopy Unit at Mount Zion (Endoscopy Only) Recruiting
San Francisco, California, United States, 94115
UCSF/Medical Center at Mount Zion Recruiting
San Francisco, California, United States, 94115
United States, Connecticut
Bristol Hospital Recruiting
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Foundation Recruiting
Bristol, Connecticut, United States, 06010
Endoscopy Center of Connecticut, LLC Recruiting
Guilford, Connecticut, United States, 06437
Endoscopy Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Gastroenterology Center of Connecticut, PC Recruiting
Hamden, Connecticut, United States, 06518
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Yale New Haven Hospital Active, not recruiting
New Haven, Connecticut, United States, 06510
Yale University School of Medicine Active, not recruiting
New Haven, Connecticut, United States, 06510
Central Connecticut Endoscopy Center Recruiting
Plainville, Connecticut, United States, 06062
United States, Florida
Gastroenterology Associates (colonoscopy) Active, not recruiting
Crystal River, Florida, United States, 34429
Nature Coast Clinical Research Active, not recruiting
Inverness, Florida, United States, 34452
Suncoast Endoscopy Center (colonoscopy) Active, not recruiting
Inverness, Florida, United States, 34453
North Florida Gastroenterology Research, LLC Terminated
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center Terminated
Orlando, Florida, United States, 32806
Internal Medicine Specialists Terminated
Orlando, Florida, United States, 32806
Advanced Gastroenterology Center Recruiting
Port Orange, Florida, United States, 32127
Advanced Medical Research Center Recruiting
Port Orange, Florida, United States, 32127
Endoscopy Center Recruiting
Port Orange, Florida, United States, 32127
Port Orange Urgent Care Recruiting
Port Orange, Florida, United States, 32127
Florida Medical Clinic, P.A. Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center (COLONOSCOPY) Recruiting
Alpharetta, Georgia, United States, 30005
Atlanta Center for Gastroenterology, P.C. Active, not recruiting
Decatur, Georgia, United States, 30033
Gastroenterology Associates of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Specialists, PC Recruiting
Suwanee, Georgia, United States, 30024
United States, Kansas
Cotton-O'Neil Clinical Research Center Digestive Health Recruiting
Topeka, Kansas, United States, 66606
United States, Maryland
Gastrointestinal Diagnostic Center Active, not recruiting
Baltimore, Maryland, United States, 21229
Digestive Disease Associates, PA Active, not recruiting
Catonsville, Maryland, United States, 21228
Gastrointestinal Diagnostic Center Active, not recruiting
Catonsville, Maryland, United States, 21228
Chevy Chase Clinical Research/Metropolitan Gastroenterology Group Recruiting
Chevy Chase, Maryland, United States, 20815
Chevy Chase Endoscopy Center Recruiting
Chevy Chase, Maryland, United States, 20815
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research Recruiting
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Saint Joseph Mercy Hospital - Inpatient Pharmacy (drug ship only) Recruiting
Ann Arbor, Michigan, United States, 48106
East Ann Arbor Health and Geriatrics Center -UMHS Recruiting
Ann Arbor, Michigan, United States, 48109-2701
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5000
Michigan Clinical Research Unit - UMHS Recruiting
Ann Arbor, Michigan, United States, 48109-5872
Medical Science Research Building 1 - UMHS Recruiting
Ann Arbor, Michigan, United States, 48109
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
Center for Digestive Health Recruiting
Troy, Michigan, United States, 48098
Surgical Centers of Michigan Recruiting
Troy, Michigan, United States, 48098
Michigan Heart SJMH (blood draw only) Recruiting
Ypsilanti, Michigan, United States, 48106
Huron Gastroenterology Associates Recruiting
Ypsilanti, Michigan, United States, 48197
Saint Joseph Mercy Hospital Outpatient Laboratory (blood draw only) Recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC Recruiting
Egg Harbor Township, New Jersey, United States, 08234
South Jersey Gastroenterology, P.A. Active, not recruiting
Marlton, New Jersey, United States, 08053
South Jersey Gastroenterology Active, not recruiting
Marlton, New Jersey, United States, 08053
The Gastroenterology Group of South Jersey Active, not recruiting
Vineland, New Jersey, United States, 08360
United States, New York
NYU Langone Long Island Clinical Research Associates Recruiting
Great Neck, New York, United States, 11021
NYU Langone Nassau Gastroenterology Associates Recruiting
Great Neck, New York, United States, 11021
The Private Practice of Simon Lichtiger, MD Recruiting
New York, New York, United States, 10028
IBD Center - The Mount Siani Hospital Recruiting
New York, New York, United States, 10029
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Ican School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Columbia University Medical Center (Endoscopy Only) Recruiting
New York, New York, United States, 10032
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
CUMC Research Pharmacy (Drug Shipment Only) Recruiting
New York, New York, United States, 10032
Kornbluth, Legnani, George MD, PC Recruiting
New York, New York, United States, 10128
University of Rochester Active, not recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Carolina Research, Carolina Digestive Diseases Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
Mentor Medical Campus Recruiting
Mentor, Ohio, United States, 44060
The Endoscopy Center of Lake County Recruiting
Mentor, Ohio, United States, 44060
United States, Tennessee
Vanderbilt University Medical Center - IBD Clinic Recruiting
Nashville, Tennessee, United States, 37212-1375
Vanderbilt University Medical Center - GI Research Office Recruiting
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center - Drug Shipment Recruiting
Nashville, Tennessee, United States, 37232-7610
Vanderbilt University Medical Center - GCRC Recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - Heart Station Recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - Laboratory (Chest X-Ray) Recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Clinical Research Institute Recruiting
Arlington, Texas, United States, 76012
Baylor College of Medicine (Drug Storage) Recruiting
Houston, Texas, United States, 77030
Baylor College of Medicine - Baylor Medical Center Recruiting
Houston, Texas, United States, 77030
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
The University of Texas Houston Health Science Center Recruiting
Houston, Texas, United States, 77030
Tyler Research Institute, LLC Recruiting
Tyler, Texas, United States, 75701
United States, Utah
Alpine Medical Group Recruiting
Salt Lake City, Utah, United States, 84102
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Wasatch Endoscopy Center Recruiting
Salt Lake City, Utah, United States, 84124
United States, Virginia
VCU Health System Digestive Health Center Recruiting
Richmond, Virginia, United States, 23298
VCU Health System Endoscopy Suite Recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
United States, Wisconsin
Wisconsin Center for Advanced Research - GI Associates, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Australia, Australian Capital Territory
The Canberra Hospital Active, not recruiting
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Nepean Hospital Active, not recruiting
Kingswood, New South Wales, Australia, 2747
Liverpool Hospital eastern Campus Recruiting
Liverpool, New South Wales, Australia, 2170
Australia, Victoria
Eastern Health-Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Monash Health, Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Austria
Landeskrankenhaus Innsbruck Active, not recruiting
Innsbruck, Austria, 6020
Krankenhaus Barmherzige Brueder St. Veit/Glan Active, not recruiting
St. Veit an der Glan, Austria, 9300
AKH Wien Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Austria, 1090
Belgium
GZA St Vincentius Recruiting
Antwerpen, Belgium, 2018
GZA St. Vincentius Antwerpen Recruiting
Antwerpen, Belgium, 2018
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
H-Hartziekenhuis Roeselare-Menen vzw Active, not recruiting
Roeselare, Belgium, 8800
Brazil
Hospital de Clinicas de Porto Alegre - HCPA Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Canada, Alberta
University of Calgary, Heritage Medical Research Clinic, TRW Building Active, not recruiting
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta - Zeidler Ledcor Centre Active, not recruiting
Edmonton, Alberta, Canada, T6G 2X8
Canada, Ontario
McMaster University Medical Center Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Canada, Quebec
Hopital Maisonneuve-Rosemont/Pavillon Rachel-Tourigny Active, not recruiting
Montreal, Quebec, Canada, H1T 2M4
Montreal General Hospital-McGill University Health Centre Active, not recruiting
Montreal, Quebec, Canada, H3G 1A4
Canada, Saskatchewan
Saskatoon City Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Instituto de Coloproctologia ICO S.A.S. Active, not recruiting
Medellin, Antioquia, Colombia, 00000
Croatia
University Hospital Center Zagreb Active, not recruiting
Zagreb, Croatia, 10 000
Czech Republic
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czech Republic, 500 12
Klinicke Centrum ISCARE I.V.F., Gastroenterologie Recruiting
Praha 7, Czech Republic, 170 04
Nemocnice Strakonice, a.s., Interni oddeleni Recruiting
Strakonice, Czech Republic, 386 29
Krajska zdravotni, a.s., Masarykova nemocnice Usti nad Labem, o.z. Recruiting
Usti nad Labem, Czech Republic, 40113
Denmark
Bispebjerg Hospital Active, not recruiting
Copenhagen, NV, Denmark, 2400
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Aarhus University Hospital Recruiting
Aarhus C, Denmark, 8000
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Odense University Hospital Recruiting
Odense C, Denmark, 5000
Estonia
ECG Unit, Innomedica OU and Qualitas AS (ECG Only) Active, not recruiting
Tallinn, Estonia, 10117
Innomedica OU Active, not recruiting
Tallinn, Estonia, 10117
West Tallinn Central Hospital Internal Diseases Clinic Recruiting
Tallinn, Estonia, 10617
Mammograaf OU (Endoscopy Only) Active, not recruiting
Tallinn, Estonia, 13419
France
CHU Amiens-Picardie - Hopital Sud Recruiting
Amiens, France, 80054
Hôpital Haut-Lévêque - Service pharmacie essais clinique Recruiting
Bordeaux, France, 33604
Hopital Beaujon Gastroenterologie, MICI et Assistance Nutritive Recruiting
Clichy Cedex, France, 92110
CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie Recruiting
Nantes, France, 44093
Hopital Saint Antoine - Service de Gastroenterologie Recruiting
Paris cedex 12, France, 75571
Hôpital Saint Louis - Service d'hepato-gastroenterologie Active, not recruiting
Paris, France, 75010
Hôpital Saint Louis Active, not recruiting
Paris, France, 75010
Hôpital Haut-Lévêque - CMC Magellan Recruiting
PESSAC cedex 6, France, 33604
CHU de Reims - Hopital Robert Debre Recruiting
Reims cedex, France, 51092
Hopital Nord Recruiting
St Priest En Jarez, France, 42270
Hopital Rangueil Active, not recruiting
Toulouse Cedex 9, France, 31059
Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel Recruiting
Kiel, Schleswig-holstein, Germany, 24105
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit Recruiting
Berlin, Germany, 13353
Universitätsklinikum Halle Universitaetsklinik und Poliklinik fuer Innere Medizin I Recruiting
Halle, Germany, 06120
Medizinische Hochschule hannover Recruiting
Hannover, Germany, 30625
Klinikum Lueneburg Recruiting
Lueneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden Active, not recruiting
Minden, Germany, 32423
University Hospital Munich-Grosshadern Recruiting
Munich, Germany, 81377
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Hungary
Pro Urbe Vaciensi Javorszky Odon Korhaz Recruiting
Vac, Pest, Hungary, 2600
Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza Recruiting
Bekescsaba, Hungary, 5600
Pannonia Maganorvosi Centrum Kft. Recruiting
Budapest, Hungary, 1136
Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály Recruiting
Budapest, Hungary, H-1032
Peterfy Sandor utcai Korhaz Recruiting
Budapest, Hungary, H-1076
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly Recruiting
Budapest, Hungary, H-1125
Debreceni Egyetem Klinikai Kozpont Active, not recruiting
Debrecen, Hungary, 4032
Bekes Megyei Pandy Kalman Korhaz, III Gasztroenterologiai Osztaly Recruiting
Gyula, Hungary, 5700
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz Active, not recruiting
Miskolc, Hungary, 3526
Karolina Korhaz Recruiting
Mosonmagyarovar, Hungary, 9200
Pecsi Tudomanyegyetem Klinikai Kozpont Active, not recruiting
Pecs, Hungary, 7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika Recruiting
Szeged, Hungary, 6720
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
The Edith Wolfson Medical Center/Gastroenterology Department Active, not recruiting
Holon, Israel, 58100
Rabin Medical Center, Beilinson campus Recruiting
Petah Tikva, Israel, 49100
Italy
Istituto Clinico Humanitas - Istituti di Ricovero E Cura A Carattere Scientifico (IRCSS) Recruiting
Rozzano, Milano, Italy, 20089
AOR Villa Sofia-Cervello Recruiting
Palermo, PA, Italy, 90146
AOU Mater Domini - U.O. Fisiopatologia Digestiva Recruiting
Catanzaro, Italy, 88100
Japan
Aichi Medical University Hospital Recruiting
Nagakute, Aichi, Japan, 480-1195
National Hospital Organization Hirosaki National Hospital Recruiting
Hirosaki, Aomori, Japan, 036-8545
Toho University Sakura Medical Center Recruiting
Sakura, Chiba, Japan, 285-8741
Kurume University Hospital Recruiting
Kurume, Fukuoka, Japan, 830-0011
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-0033
The Hospital of Hyogo College of Medicine Active, not recruiting
Nishinomiya-shi, Hyogo, Japan, 6638501
National Hospital Organization Mito Medical Center Recruiting
Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
Sameshima Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 892-0846
Kuniyoshi Hospital Recruiting
Kochi-shi, Kochi, Japan, 780-0901
National Hospital Organization Sendai Medical Center Active, not recruiting
Sendai, Miyagi, Japan, 983-8520
Osaka City University Hospital Recruiting
Osaka-City, Osaka, Japan, 545-8586
Osaka Medical College Hospital Recruiting
Takatsuki-shi, Osaka, Japan, 569-8686
Shiga University of Medical Science Hospital Recruiting
Otsu-shi, Shiga, Japan, 520-2192
Tokai University Hachioji Hospital Recruiting
Hachioji, Tokyo, Japan, 192-0032
Jikei University Hospital Active, not recruiting
Minato-ku, Tokyo, Japan, 105-8471
Kitasato University Kitasato Institute Hospital Recruiting
Minato-ku, Tokyo, Japan, 108-8642
Keio University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Fukuoka University Chikushi Hospital Recruiting
Fukuoka, Japan, 818-8502
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Tokyo Medical And Dental University Hospital, Faculty of Medicine Recruiting
Tokyo, Japan, 113-8519
Showa University Hospital Recruiting
Tokyo, Japan, 142-8666
Korea, Republic of
Hanyang University Guri Hospital Recruiting
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Kyung Hee University Hospital, Clinical Laboratory Recruiting
Dongdaemun-gu, Seoul, Korea, Republic of, 130-872
Gachon University Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 02447
Severance Hospital-Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Seoul National University Hospital, Active, not recruiting
Seoul, Korea, Republic of, 110-744
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of, 130-872
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Latvia
Digestive Diseases Center GASTRO Recruiting
Riga, Latvia, LV-1006
ECG room, Clinic "Linezers" Recruiting
Riga, Latvia, LV-1006
X-Ray Department, Clinic "Linezers" Recruiting
Riga, Latvia, LV-1006
Netherlands
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
Academic Medical Center (AMC) Recruiting
Amsterdam, Netherlands, 1105 AZ
University Medical Center Groningen (UMCG) Active, not recruiting
Groningen, Netherlands, 9713 GZ
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
New Zealand
Shakespeare Specialist Group Recruiting
Milford, Auckland, New Zealand, 0620
Tauranga Hospital Recruiting
Tauranga, Bay of Plenty, New Zealand, 3143
Christchurch Hospital Recruiting
Christchurch, Cantebury, New Zealand, 8011
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Southern District Health Board Recruiting
Dunedin, New Zealand, 9016
Waikato Hospital Recruiting
Hamilton, New Zealand, 3240
Clinical Trials Unit, Bay of Plenty Clinical School Recruiting
Tauranga, New Zealand, 3112
P3 Research Limited Recruiting
Wellington, New Zealand, 6021
Pacific Radiology (X-rays only) Recruiting
Wellington, New Zealand, 6021
Bowen Hospital Recruiting
Wellington, New Zealand, 6035
Poland
Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o. Recruiting
Lodz, Iodzkie, Poland, 90-302
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Szpital Uniwersytecki nr 2 im. dr Jana Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Centrum Endoskopii Zabiegowej Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Gabinet Lekarski - Janusz Rudzinski Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital Active, not recruiting
Bialystok, Podlaskie, Poland, 15-950
H-T. Centrum Medyczne - ENDOTERAPIA Recruiting
Tychy, Slaskie, Poland, 43-100
Gabinet Endoskopii Przewodu Pokarmowego Recruiting
Krakow, Poland, 31-009
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej Recruiting
Lodz, Poland, 90-153
Endoskopia Sp. Z O.O. Recruiting
Sopot, Poland, 81-756
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob Recruiting
Warszawa, Poland, 02-507
Nzoz Vivamed Recruiting
Warszawa, Poland, 03-580
Lexmedica Recruiting
Wroclaw, Poland, 53-114
Romania
Cabinet Particular Policlinic Algomed SRL Recruiting
Timisoara, Timis, Romania, 300002
Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie Active, not recruiting
Bucuresti, Romania, 050098
Russian Federation
Municipal Budget Institution of Healthcare of Novosibirsk Recruiting
Novosibirsk, Russia, Russian Federation, 630084
State budget institution of healthcare of Yaroslavl region, Regional clinical hospital Recruiting
Yaroslavl, Russia, Russian Federation, 150062
Federal state budget institution Recruiting
Moscow, Russian Federation, 123423
State budget Healthcare Institution Moscow regional scientific research clinical institute Active, not recruiting
Moscow, Russian Federation, 129110
State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A. Recruiting
Nizhniy Novgorod, Russian Federation, 603126
Federal State Budgetary Institution "Scientific Research Institute of Physiology and Fundamental Recruiting
Novosibirsk, Russian Federation, 630117
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara" Recruiting
Samara, Russian Federation, 443029
Limited Liability Company Medical Company "Hepatolog" Recruiting
Samara, Russian Federation, 443093
Samara Diagnostic center, X-ray Department Recruiting
Samara, Russian Federation, 443093
Serbia
Clincial Centre of Serbia Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Centre Zvezdara Recruiting
Belgrade, Serbia, 11000
Military Medical Academy Recruiting
Belgrade, Serbia, 11000
Clinical Centre of Kragujevac Recruiting
Kragujevac, Serbia, 34000
Clinical Centre of Vojvodina Recruiting
Novi Sad, Serbia, 21000
General Hospital "Djordje Joanovic" Recruiting
Zrenjanin, Serbia, 23000
Slovakia
Medak s.r.o. Recruiting
Bratislava, Slovakia, 85101
"KM Management spol. s.r.o.Gastroenterologicke a hepatologicke centrum Nitra Recruiting
Nitra, Slovakia, 949 01
Poliklinika Libris, Synergy group, a.s., Recruiting
Nove Mesto nad Vahom, Slovakia, 915 01
Gastro L., s.r.o. Recruiting
Presov, Slovakia, 080 01
South Africa
Chris Hani Baragwanath Academic Hospital Recruiting
Johannesburg, Gauteng, South Africa, 2013
Panorama Medi-Clinic Recruiting
Cape Town, Western Cape, South Africa, 7500
The Loius Leipoldt Medical Centre Recruiting
Cape Town, Western Cape, South Africa, 7530
Dr JP Wright Recruiting
Cape Town, Western Cape, South Africa, 7708
Endocare Research Centre Recruiting
Western Cape, South Africa, 7646
Spain
Hospital Universitario de Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Madrid,, Spain, 28942
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Corporacio Sanitaria Parc Tauli Active, not recruiting
Barcelona, Spain, 08208
Hospital Universitario La Princesa Active, not recruiting
Madrid, Spain, 28006
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Taiwan
National Taiwan University Hospital Active, not recruiting
Taipei City, Taiwan, 10002
Ukraine
Motor-Sich clinic, LLC Recruiting
Zaporizhzhia, Ukrain, Ukraine, 69068
Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital' Recruiting
Chernivtsi, Ukraine, 58001
Regional Municipal Institution Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases Active, not recruiting
Dnipropetrovsk, Ukraine, 49074
Municipal Healthcare Institution 'Kharkiv City Clinical Hospital #2' Recruiting
Kharkiv, Ukraine, 61037
State Institution "National L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Active, not recruiting
Kharkov, Ukraine, 61039
Kyiv Municipal Clinical Hospital #18, Proctology Department Recruiting
Kyiv, Ukraine, 01030
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital, Recruiting
Lviv, Ukraine, 79059
State Institution "Railway Hospital of the Public InstitutionI "Odesa Railway"", Recruiting
Odesa, Ukraine, 65010
Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department Recruiting
Odesa, Ukraine, 65025
State Institution "District Clinical Hospital of Uzhgorod Station State Territorial and Sectoral Recruiting
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Recruiting
Vinnytsia, Ukraine, 21005
Minicipal Institution City Hospital #7, Therapeutic Department, Recruiting
Zaporizhzhia, Ukraine, 69118
United Kingdom
Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
Bristol Royal Infirmary Recruiting
Bristol, England, United Kingdom, BS2 8HW
Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, England, United Kingdom, CB2 0QQ
The North West London Hospitals NHS Trust Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
The North West London Hospitals NHS Trust-St. Mark's Hospital Recruiting
Harrow, United Kingdom, HA13UJ
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY United Kingdom
Norfolk and Norwich University Hospital Recruiting
Norwich, United Kingdom, NR4 7UY
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01470612     History of Changes
Other Study ID Numbers: A3921139  2011-004581-14  OCTAVEOPEN 
Study First Received: October 21, 2011
Last Updated: November 16, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 05, 2016