Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470612
First received: October 21, 2011
Last updated: November 20, 2014
Last verified: November 2014
  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: 725
Study Start Date: October 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: June 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
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
Horizon Research Group, Inc. Not yet recruiting
Mobile, Alabama, United States, 36608
Internal Medicine Center, LLC Not yet recruiting
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital Not yet recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Desert Sun Clinical Research, LLC Recruiting
Tucson, Arizona, United States, 85710
Desert Sun Gastroenterology Recruiting
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center Recruiting
Tucson, Arizona, United States, 85710
United States, California
UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center Recruiting
La Jolla, California, United States, 92037-0845
UCSD Medical Center Recruiting
La Jolla, California, United States, 92093
Cedars Sinai Medical Center Medical Office Towers Recruiting
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
MD Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
Regulatory Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
Alliance Clinical Research Not yet recruiting
Oceanside, California, United States, 92056
Clinical Applications Laboratories, Inc. Recruiting
San Diego, California, United States, 92103
Sharp Rees-Stealy Medical Group Recruiting
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group, Inc. Recruiting
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group, Inc. Recruiting
San Diego, California, United States, 92123
Medical Center at Mount Zion Recruiting
San Francisco, California, United States, 94115
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center Not yet recruiting
Torrance, California, United States, 90502
United States, Colorado
Rocky Mountain Clinical Research, LLC (Administrative Office) Not yet recruiting
Denver, Colorado, United States, 80222
Rocky Mountain Gastroenterology Not yet recruiting
Lakewood, Colorado, United States, 80215
Rocky Mtn. Clinical Research, LLC Not yet recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Bristol Hospital Not yet recruiting
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Foundation Not yet recruiting
Bristol, Connecticut, United States, 06010
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Endoscopy Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06437
Gastroenterology Center of Connecticut, PC Recruiting
Hamden, Connecticut, United States, 06518
Endoscopy Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Yale University School of Medicine, Dept Internal Medicine/Sect Digestive Diseases Recruiting
New Haven, Connecticut, United States, 06510
Central Connecticut Endoscopy Center Not yet recruiting
Plainville, Connecticut, United States, 06062
United States, Florida
Center for Advanced Gastroenterology Not yet recruiting
Maitland, Florida, United States, 32751
MNH Surgical Center Not yet recruiting
Maitland, Florida, United States, 32751
Gastroenterology Group of Naples Not yet recruiting
Naples, Florida, United States, 34102
North Florida Gastroenterology Research, LLC Not yet recruiting
Orange Park, Florida, United States, 32073
Orange Park Surgery Center Not yet recruiting
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center Not yet recruiting
Orlando, Florida, United States, 32806
Internal Medicine Specialists Not yet recruiting
Orlando, Florida, United States, 32806
Advanced Gastroenterology Center Recruiting
Port Orange, Florida, United States, 32127
Port Orange Urgent Care Recruiting
Port Orange, Florida, United States, 32127
Endoscopy Center Recruiting
Port Orange, Florida, United States, 32127
Advanced Medical Research Center 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 Gastroenterology Associates, LLC. Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology Associates LLC Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology Associates Not yet recruiting
Atlanta, Georgia, United States, 30342
Cardiovascular Specialist Not yet recruiting
Atlanta, Georgia, United States, 30342
GI Consultants (COLONOSCOPY) Recruiting
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Center for Gastroenterology, P.C. Not yet recruiting
Decatur, Georgia, United States, 30033
Emory Healthcare Heart Center (EKG) Recruiting
Johns Creek, Georgia, United States, 30097
Gastroenterology Associates of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Specialists, PC Recruiting
Suwanee, Georgia, United States, 30024
United States, Illinois
Southwest Gastroenterology Not yet recruiting
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Cotton-O'Neil Clinical Research Center Digestive Health Recruiting
Topeka, Kansas, United States, 66606
United States, Maryland
Digestive Disease Associates, PA Recruiting
Baltimore, Maryland, United States, 21229
Gastrointestinal Diagnostic Center Recruiting
Baltimore, Maryland, United States, 21229
Digestive Disease Associates, PA Recruiting
Catonsville, Maryland, United States, 21228
Metropolitan Gastroenterology Group, PC- Chevy Chase Clinical Not yet recruiting
Chevy Chase, Maryland, United States, 20815
Howard County GIDC Recruiting
Columbia, Maryland, United States, 21044
United States, Michigan
Saint Joseph Mercy Hospital - Inpatient Pharmacy (drug ship only) Not yet recruiting
Ann Arbor, Michigan, United States, 48106
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5000
Clinical Research Institute of Michigan, LLC Not yet 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
Saint Joseph Mercy Hospital Outpatient Laboratory (blood draw only) Not yet recruiting
Ypsilanti, Michigan, United States, 48197
Michigan Heart SJMH (blood draw only) Not yet recruiting
Ypsilanti, Michigan, United States, 48106
Huron Gastroenterology Associates / Center for Digestive Care Not yet recruiting
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
AGA Clinical Research Associates, LLC Recruiting
Egg Harbor Township, New Jersey, United States, 08234
South Jersey Gastroenterology Recruiting
Marlton, New Jersey, United States, 08053
The Gastroenterology Group of South Jersey Recruiting
Vineland, New Jersey, United States, 08360
The Endo Center at Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Long Island Clinical Research Associates LLP Recruiting
Great Neck, New York, United States, 11021
Nassau Gastroenterology Associates Office Based Surgery Recruiting
Great Neck, New York, United States, 11021
Nassau Gastroenterology Associates P.C. Recruiting
Great Neck, New York, United States, 11021
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
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Kornbluth, Legnani, George MD, PC Recruiting
New York, New York, United States, 10128
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Mount Sinai School Of Medicine Recruiting
New York, New York, United States, 10029
Mount Sinai School of Medicine Faculty Practice Associates Recruiting
New York, New York, United States, 10029
Present, Chapman, Marion, Lichtiger MD, PC Recruiting
New York, New York, United States, 10028
University of Rochester Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
Charlotte Gastroenterology & Hepatology, PLLC (Endoscopy only) Not yet recruiting
Charlotte, North Carolina, United States, 28207
Charlotte Gastroenterology & Hepatology, PLLC Not yet recruiting
Charlotte, North Carolina, United States, 28207
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, Pennsylvania
Guthrie Medical Group, P.C. and Robert Packer Hospital Not yet recruiting
Sayre, Pennsylvania, United States, 18840
Guthrie Clinic Limited Not yet recruiting
Sayre, Pennsylvania, United States, 18840
Donald Guthrie Foundation for Education and Research Not yet recruiting
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
Vanderbilt University Medical Center - Laboratory (Chest X-Ray) Recruiting
Nashville, Tennessee, United States, 37232
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 - GI Research Office Recruiting
Nashville, Tennessee, United States, 37212-1610
Vanderbilt University Medical Center - Heart Station Recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - IBD Clinic Recruiting
Nashville, Tennessee, United States, 37212-1375
United States, Texas
Baylor College of Medicine (Drug Storage) Recruiting
Houston, Texas, United States, 77030
Baylor Medical Center Recruiting
Houston, Texas, United States, 77030
Houston Hospital for Specialized Surgery Recruiting
Houston, Texas, United States, 77030
The University of Texas Houston Health Science Center Recruiting
Houston, Texas, United States, 77030
Digestive Health Specialists of Tyler 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 Not yet recruiting
Richmond, Virginia, United States, 23298
VCU Health System Endoscopy Suite Not yet recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
United States, Wisconsin
The Center for Digestive Help Recruiting
Milwaukee, Wisconsin, United States, 53215
Wisconsin Center for Advanced Research Recruiting
Milwaukee, Wisconsin, United States, 53215
Wisconsin Center for Advanced Research - GI Associates, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Australia, Australian Capital Territory
The Canberra Hospital/Gastroenterology & Hepatology Unit, Level 2, Building 1 Not yet recruiting
Garron, 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
NBM LHD, Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Liverpool Hospital Eastern Campus Recruiting
Liverpool, New South Wales, Australia, 2170
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Eastern Health, Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Monash Medical Centre Not yet recruiting
Clayton, Victoria, Australia, 3168
Australia
SA Pathology Not yet recruiting
Adelaide, Australia, 5000
Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Vienna, Austria, 1090
AKH Wien, Universitaetsklinik fuer Innere Medizin III, Klinische Abteilung fuer Gastroenterologie Recruiting
Wien, Vienna, Austria, 1090
Medizinische Universität Innsbruck Recruiting
Innsbruck, Austria, A-6020
Belgium
GZA St. Vincentius Recruiting
Antwerpen, Belgium, 2018
AZ Groeninge Not yet recruiting
Kortrijk, Belgium, 8500
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Brazil
Hospital de Clinicas de Porto Alegre - HCPA Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Unidade Integrada de Gastroenterologia - Unigastro Not yet recruiting
Campinas, Sao Paulo, Brazil, 13070-040
Hospital Universitario Clementino Fraga Filho/UFRJ Recruiting
Rio de Janeiro, Brazil, 21941-913
Canada, Alberta
University of Calgary, Heritage Medical Research Clinic, TRW Building Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Zeidler Ledcor Centre, University Of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2X8
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre Recruiting
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta - Zeidler Ledcor Centre Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Canada, Ontario
McMaster University Medical Center Recruiting
Hamilton, Ontario, Canada, L8S 4K1
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Robarts Clinical Trials - Robarts Research Institute Recruiting
London, Ontario, Canada, N6A 5K8
Canada, Quebec
McGill University Health Centre - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Maisonneuve-Rosemont Hospital Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Saskatoon City Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Colombia
Instituto de Coloproctologia ICO S.A.S. Recruiting
Medellin, Antioquia, Colombia, 00000
Hadassah - Hebrew University Hospital Ein Kerem Recruiting
Jerusalem, Colombia, 91120
Croatia
University Hospital Center Osijek, Clinic of Internal Medicine Not yet recruiting
Osijek, Croatia, 31 000
University Hospital Rijeka, Department of Gastroenterology and Hepatology Not yet recruiting
Rijeka, Croatia, 51000
General Hospital Zadar Not yet recruiting
Zadar, Croatia, 23 000
University Hospital Center Zagreb Not yet recruiting
Zagreb, Croatia, 10 000
Czech Republic
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czech Republic, 500 12
Institut klinicke a experimentalni mediciny Not yet recruiting
Praha 4, Czech Republic, 140 21
Synlab Czech S.R.O. Recruiting
Praha 6 - Stresovice, Czech Republic, 169 00
Klinicke Centrum ISCARE I.V.F. Recruiting
Praha 7, Czech Republic, 170 04
Poliklinika Prosek, Pneumologie Recruiting
Praha 9 - Prosek, Czech Republic, 190 00
Nemocnice Strakonice, a.s., Interni oddeleni Recruiting
Strakonice, Czech Republic, 386 29
Krajska zdravotni, a.s. Masarykova nemocnice v Usti nad Labem Recruiting
Usti nad Labem, Czech Republic, 40113
Denmark
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Aarhus University Hospital Department of Hepato Gastroenterrology V Aarhus Recruiting
Aarhus C, Denmark, 8000
Bispebjerg Hospital Recruiting
Copenhagen NV, Denmark, DK2400
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Odense University Hospital Department of Medical Gastroenterology S Odense University Hospital Recruiting
Odense, Denmark, 5000
Estonia
ECG Unit of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
ECG Unit, Innomedica MCRC Recruiting
Tallinn, Estonia, 10117
X-Ray Department of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
X-Ray department, Daugavpils Regional Hospital Recruiting
Tallinn, Estonia, 10117
X-Ray Unit, East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10138
ECG Unit East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10138
Tartu University Hospital Division of Endocrinology and Gastroenterology Not yet recruiting
Tartu, Estonia, 51014
France
Hopital Saint-Louis Recruiting
Paris Cedex 10, ILF, France, 75010
CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie Not yet recruiting
Amiens Cedex 01, France, 80054
Hopital Saint Andre Not yet recruiting
Bordeaux cedex, France, 33075
Hopital Beaujon, Gastroenterologie, Recruiting
Clichy, France, 92118
CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie Not yet recruiting
Nantes, France, 44093
Hopital Saint Louis - Service d'hepato-gastroenterologie Recruiting
Paris, France, 75010
Hopital Saint Antoine - Service de Gastroenterologie Recruiting
Paris cedex 12, France, 75571
CHU de Reims - Hopital Robert Debre Not yet recruiting
Reims cedex, France, 51092
Hopital Nord Recruiting
St Priest En Jarez, France, 42270
Hopital Rangueil Recruiting
Toulouse Cedex 9, France, 31059
Germany
Klinikum Luneburg Recruiting
Bogelstrafße 1, Luneburg, Germany, 21339
Universitatsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Schiewig Holstein, Germany, 24105
Charite Campus Virchow-Klinikum Universitaetsmedizin Berlin Recruiting
Berlin, Germany, 13353
Klinikum der Johann Wolfgang Goethe-Universitaet Not yet recruiting
Frankfurt, Germany, 60590
Universitätsklinikum Halle, Universitaetsklinik und Poliklinik fuer Innere Medizin I Not yet recruiting
Halle, Germany, 06120
Medizinische Hochschule hannover Recruiting
Hannover, Germany, 30625
Klinikum Lüneburg/Abteilung Gastroenterologie Recruiting
Lüneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden Recruiting
Minden, Germany, 32423
University Hospital Munich-Grosshadern Recruiting
Munich, Germany, 81377
Universitaetsklinikum Ulm Recruiting
Ulm, Germany, 89081
Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház Recruiting
Miskolc, Hungary, Europe, Hungary, H-3526
Dr. Rethy Pal Korhaz-Rendelointezet/III. Belgyogyaszat Not yet recruiting
Bekescsaba, Hungary, 5600
Magyar Honvedseg Egeszsegugyi Kozpont Not yet recruiting
Budapest, Hungary, 1134
Pannonia Maganorvosi Centrum Kft. Not yet recruiting
Budapest, Hungary, H-1136
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
Szent János Kórház és Észak-budai Egyesített Kórházak. Not yet recruiting
Budapest, Hungary, H-1125
Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály Not yet recruiting
Budapest, Hungary, H-1032
Szent Pantaleon Korhaz- Rendelointezet, Belgyogyaszat- Gasztroenterologiai Osztaly Not yet recruiting
Dunaujvaros, Hungary, 2400
Bekes Megyei Pandy Kalman Korhaz, III Gasztroenterologiai Osztaly Not yet recruiting
Gyula, Hungary, 5700
Somogy Megyei Kaposi Mor Oktato Korhaz Not yet recruiting
Kaposvar, Hungary, H-7400
Karolina Korhaz Rendelointezet ,Belgyogyaszat Recruiting
Mosonmagyarovar, Hungary, H-9200
Pecsi Tudomanyegyetem Klinikai Kozpont Recruiting
Pecs, Hungary, 7624
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, I. Sz. Belgyogyaszati Klinika Recruiting
Szeged, Hungary, 6720
Javorszky Odon Korhaz Not yet recruiting
Vac, Hungary, H2600
Israel
Bnai Zion Medical Center Not yet recruiting
Haifa, Israel, 31048
Rambam Health Care Center Not yet recruiting
Haifa, Israel, 31096
The Edith Wolfson Medical Center/Gastroenterology Department Recruiting
Holon, Israel, 58100
Rabin Medical Center, Beilinson campus Not yet recruiting
Petah Tikva, Israel, 49100
Kaplan Medical Center Not yet recruiting
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Italy
AOR Villa Sofia-Cervello Not yet recruiting
Palermo, PA, Italy, 90146
Centro di Riferimento Oncologico Not yet recruiting
Aviano, PN, Italy, 33081
AOU Mater Domini - U.O. Fisiopatologia Digestiva Recruiting
Catanzaro, Italy, 88100
Istituto Clinico Humanitas IRCCS - IBD Center Recruiting
Milan, Italy, 20089
Japan
Aichi Medical University Hospital Recruiting
Nagakute, Aichi, Japan, 480-1195
National Hospital Organization Hirosaki National Hospital Recruiting
Hirosaki, Aomori, Japan, 0368545
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 Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
National Hospital Organization Mito Medical Center Recruiting
Higashi-ibaraki-gun, Ibaraki, Japan, 311-3193
Susakikuroshio Hospital Recruiting
Susaki, Kouchi, Japan, 785-8501
National Hospital Organization Sendai Medical Center Gastroenterology Recruiting
Sendai, Miyagi, Japan, 983-8520
Osaka Medical College Hospital Recruiting
Takatsuki, Osaka, Japan, 569-8686
Shiga University of Medical Science Hospital Recruiting
Otsu, Shiga, Japan, 520-2192
Keio University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Toho University Sakura Medical Center Recruiting
Chiba, Japan, 285-8741
Fukuoka University Chikushi Hospital Recruiting
Fukuoka, Japan, 818-8502
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Sameshima Hospital Recruiting
Kagoshima, Japan, 892-0846
Kuniyoshi Hospital Recruiting
Kochi, Japan, 780-0901
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Japan Community Health care Organization Tokyo Yamate Medical Center Recruiting
Tokyo, Japan, 169-0073
Jikei University Hospital Recruiting
Tokyo, Japan, 105-8471
Kitasato University Kitasato Institute Hospital Recruiting
Tokyo, Japan, 108-8642
NTT Medical Center Tokyo Recruiting
Tokyo, Japan, 141-8625
Showa University Hospital Recruiting
Tokyo, Japan, 142-8666
Tokai University Hachioji Hospital Recruiting
Tokyo, Japan, 192-0032
Tokyo Medical And Dental University Hospital, Faculty of Medicine Recruiting
Tokyo, Japan, 113-8519
Korea, Republic of
Pusan National University Hospital Not yet recruiting
Seo-Gu, Busan, Korea, Republic of, 602-739
Pusan National University Hospital, Clinical Laboratory Not yet recruiting
Seo-Gu, Busan, Korea, Republic of, 602-739
CHA Bundang Medical Center, CHA University Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Hanyang University Guri Hospital Recruiting
Guri-si, Gyunggi-do, Korea, Republic of, 471-701
Kyung Hee University Hospital, Clinical Laboratory Recruiting
Dongdaemun-gu, Seoul, Korea, Republic of, 130-872
Gachon University Gil Hospital Not yet recruiting
Incheon, Korea, Republic of, 405-760
Gachon University Gil Hospital, Clinical Laboratory Not yet recruiting
Incheon, Korea, Republic of, 405-760
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Kyung Hee University Hospital / Department of Gastroenterology Recruiting
Seoul, Korea, Republic of, 130-872
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital, Recruiting
Seoul, Korea, Republic of, 110-744
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Latvia
Daugavpils Regional Hospital Not yet recruiting
Daugavpils, Latvia, LV-5417
Daugavpils Regional Hospital Microbiology and Clinical Laboratory Not yet recruiting
Daugavpils, Latvia, LV-5417
X-Ray Department, Clinic "Linezers" Not yet recruiting
Riga, Latvia, LV-1006
E.Gulbja Laboratorija Not yet recruiting
Riga, Latvia, LV-1006
ECG room, Clinic "Linezers" Not yet recruiting
Riga, Latvia, LV-1006
ECG Unit, P.Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
Gastroenterology Center, P.Stradins Clinical University Hospital, Not yet recruiting
Riga, Latvia, LV-1002
X-Ray Department, P.Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
Digestive Diseases Center GASTRO Not yet recruiting
Riga, Latvia, LV-1006
Netherlands
Academic Medical Center (AMC) Recruiting
Amsterdam, Netherlands, 1105 AZ
VU University Medical Center Recruiting
Amsterdam, Netherlands, 1081 HV
University Medical Center Groningen (UMCG) Recruiting
Groningen, Netherlands, 9713 GZ
Leiden University Medical Center Not yet recruiting
Leiden, Netherlands, 2333 ZA
New Zealand
Shakespeare Specialist Group Recruiting
Milford, Auckland, New Zealand, 0620
Christchurch Hospital Recruiting
Christchurch, Canterbury, New Zealand, 8011
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Southern District Health Board Recruiting
Dunedin, New Zealand, 9016
Waikato District Health Board , Dr Melissa L Haines Not yet recruiting
Hamilton, New Zealand
Waikato Hospital Not yet recruiting
Hamilton, New Zealand, 32740
Clinical Trials Unit, BOP Clinical School, Bay of Plenty District Health Board Recruiting
Tauranga, New Zealand, 3143
PathLab BOP Recruiting
Tauranga, New Zealand, 3112
Bowen Hospital Recruiting
Wellington, New Zealand, 6035
P3 Research Limited Recruiting
Wellington, New Zealand, 6021
Pacific Radiology (X-rays only) Recruiting
Wellington, New Zealand, 6021
Poland
H-T. Centrum Medyczne - ENDOTERAPIA Not yet recruiting
Tychy, Slaskie, Poland, 43-100
Oddzial Chorob Wewnetrznych i Gastroenterologii, Recruiting
Bialystok, Poland, 15-950
10 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej Recruiting
Bydgoszcz, Poland, 85-681
Gabinet Lekarski-Janusz Rudzinski Recruiting
Bydgoszcz, Poland, 85-681
Gabinet Endoskopii Przewodu Pokarmowego Recruiting
Krakow, Poland, 31-009
Centrum Endoskopii Zabiegowej Not yet recruiting
Kujawsko-Pomorskie, Poland, 85-168
Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o. Recruiting
Lodz, Poland, 90-302
Centrum Medyczne Szpital Swietej Rodziny/Research and Development Department Recruiting
Lodz, Poland, 90-302
SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi Recruiting
Lodz, Poland, 90-153
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego, Zaklad Radiologii Recruiting
Lodz, Poland, 90-153
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego, Recruiting
Lodz, Poland, 90-153
Endoskopia SP. Z O.O. Recruiting
Sopot, Poland, 81-756
Centrum Badawcze Wspolczesnej Terapii Not yet recruiting
Warszawa, Poland, 02-679
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Recruiting
Warszawa, Poland, 02-507
Nzoz Vivamed Recruiting
Warszawa, Poland, 03-580
Zaklad Diagnostyki Radiologicznej, Centralny Szpital Kliniczny MSWiA Recruiting
Warszawa, Poland, 02-507
Romania
Spitalul Clinic Judetean Mures, Sectia Clinica de Gastroenterologie Not yet recruiting
Targu Mures, Mures, Romania, 540103
Spital Clinic Dr. I. Cantacuzino Bucuresti Not yet recruiting
Bucharest, Sector 2, Romania, 020475
Spitalul Clinic Judetean de Urgenta Timisoara Not yet recruiting
Timisoara Jud Timis, Timis, Romania, 300736
Policlinica Dr Citu SRL/Internal medicine, gastroenterology Not yet recruiting
Timisoara,, Timis, Romania, 300593
Endocenter Medicina Integrativa Not yet recruiting
Bucuresti, Romania, 021978
Spitalul Universitar de Urgenta Bucuresti Recruiting
Bucuresti, Romania, cod 050098
Emergency Universitary County Hospital Tg. Mures Not yet recruiting
Targu Mures, Romania, 540136
Cabinet Particular Policlinic Algomed Srl Recruiting
Timisoara, Romania, 300002
Russian Federation
Municipal Budget Institute of Healthcare "Central City Hospital of Pyatigorsk" Not yet recruiting
Pyatigorsk, Stavropol region, Russian Federation, 357500
Federal state budget institution Recruiting
Moscow, Russian Federation, 123423
State budget Healthcare Institution Moscow regional scientific research clinical institute Recruiting
Moscow, Russian Federation, 129110
State Institution of Healthcare Nizhniy Novgorod Regional Clinical Hosp named after N.A. Semashko Recruiting
Nizhniy Novgorod, Russian Federation, 603126
Federal State Budgetary Institution "Scientific Research Institute of Physiology Not yet recruiting
Novosibirsk, Russian Federation, 630117
Novosibirsk State Medical University Recruiting
Novosibirsk, Russian Federation, 630091
City Clinical Hospital #12 Recruiting
Novosibirsk, Russian Federation, 630084
Limited Liability Company Medical Company "Hepatolog" Recruiting
Samara, Russian Federation, 443093
Non-State Healthcare Institution "Road Clinical Hospital at the station Samara" of Open Joint-Stock Recruiting
Samara, Russian Federation, 443029
Samara Diagnostic center, X-ray Department Recruiting
Samara, Russian Federation, 443093
Municipal institution of healthcare "City clinical hospital 12" Not yet recruiting
Saratov, Russian Federation, 410039
Yaroslavl State Medical Academy Not yet recruiting
Yaroslavl, Russian Federation, 150000
Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo" Not yet recruiting
Yaroslavl, Russian Federation, 150040
State budget institution of healthcare of Yaroslavl region Regional clinical hospital Not yet recruiting
Yaroslavl, Russian Federation, 150062
Clinical Hospital #2 Not yet recruiting
Yaroslavl, Russian Federation, 150010
Serbia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology Recruiting
Belgrade, Serbia, 11000
Clinical Hospital Centre Zvezdara Not yet recruiting
Belgrade, Serbia, 11000
Military Medical Academy Belgrade Recruiting
Belgrade, Serbia, 11000
Clinical Centre of Kragujevac Recruiting
Kragujevac, Serbia, 34000
Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology Not yet recruiting
Nis, Serbia, 18000
Clinical Centre of Vojvodina Not yet recruiting
Novi Sad, Serbia, 21000
General Hospital Subotica Not yet recruiting
Subotica, Serbia, 24000
General Hospital "Djordje Joanovic" Not yet recruiting
Zrenjanin, Serbia, 23000
Slovakia
CARDICONSULT, s.r.o. Not yet recruiting
Bratislava, Slovakia, 811 04
Gastroenterological Centre Thalion Not yet recruiting
Bratislava, Slovakia, 831 04
Lama Medical Care s.r.o., Gastroeneterologicko - Hepatologicke centrum Thalion Not yet recruiting
Bratislava, Slovakia, 831 04
Nestatna Gastroenterologicka ambulancia Recruiting
Bratislava, Slovakia, 851 01
Nzz - Gastroenterologicka Ambulancia Recruiting
Bratislava, Slovakia, 833 05
Prevencia a zdravie s.r.o. Recruiting
Bratislava, Slovakia, 85101
Pro RTG s. r. o. Not yet recruiting
Bratislava, Slovakia, 811 07
Jessenius - diagnosticke centrum a.s. Recruiting
Nitra, Slovakia, 949 01
Kardiocentrum Nitra s.r.o. Recruiting
Nitra, Slovakia, 949 01
KM Management spol. s.r.o. Recruiting
Nitra, Slovakia, 949 01
Poliklinika Libris, Synergy group, a.s. Not yet recruiting
Nove Mesto Nad Vahom, Slovakia, 915 01
South Africa
Chris Hani Baragwanath Academic Hospital Recruiting
Johannesburg, Gauteng, South Africa, 2013
Dr JP Wright Recruiting
Cape Town, Western Cape, South Africa, 7708
Endocare Research Centre Recruiting
Cape Town, Western Cape, South Africa, 7646
Panorama MediClinic Recruiting
Cape Town, Western Cape, South Africa, 7500
The Loius Leipoldt Medical Centre Recruiting
Cape Town, Western Cape, South Africa, 7530
Spain
Hospital Universitario de Fuenlabrada Not yet recruiting
Fuenlabrada, Madrid, Spain, 28942
Corporacio Sanitaria Parc Tauli Recruiting
Barcelona, Spain, 08208
Hospital Clinic i Provincial de Barcelona Servicio de Ap. Digestivo Recruiting
Barcelona, Spain, 08036
Hospital Universitari de Bellvitge Not yet recruiting
Barcelona, Spain, 08907
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada Not yet recruiting
Madrid, Spain, 28942
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Taiwan
Chung Shan Medical University Hospital Not yet recruiting
Taichung, R.o.c., Taiwan, 40201
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Chang Gung Memorial Foundation - Linkou Not yet recruiting
Taoyuan County, Taiwan, 333
Ukraine
I.M.C. of Crimean Republic Institution "Clinical Territorial Medical Community "University Clinic" Not yet recruiting
Simferopol, AR Krym, Ukraine, 95017
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity" Not yet recruiting
Simferopol, AR Krym, Ukraine, 95017
State Institution "S.I. Georgievsky Crimean State Medical University"/Department of Gastroenterology Not yet recruiting
Simferopol, AR Krym, Ukraine, 95017
Local laboratory of Regional Municipal Institution Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital' Not yet 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 Not yet recruiting
Dniepropetrovsk, Ukraine, 49074
Municipal Healthcare Institution "Kharkiv City Clinical Hospital #2" Recruiting
Kharkiv, Ukraine, 61037
State Institution "L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine Recruiting
Kharkiv, Ukraine, 61039
State Institution "L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine" Recruiting
Kharkiv, Ukraine, 61039
Kyiv Municipal Clinical Hospital #18, Proctology Department Recruiting
Kyiv, Ukraine, 01030
Kyiv City Clinical Hospital 8 Department Of Gastroenterology P L Shupika Not yet recruiting
Kyiv, Ukraine, 04201
LTD "St. Paraskeva Medical Center" Recruiting
Lviv, Ukraine, 79019
Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department Not yet recruiting
Odesa, Ukraine, 65025
State Institution District Clinical Hospital of Uzhgorod station Recruiting
Uzhgorod, Ukraine, 88009
"Health Clinic LLC" based on of Medical Diagnostic Center "Slaomed" "Slaomed" LLC" Not yet recruiting
Vinnytsia, Ukraine, 21029
Local Laboratory of Medical Diagnostic Center 'Slaomed' Not yet recruiting
Vinnytsia, Ukraine, 21029
Vinnytsia National Medical University Not yet recruiting
Vinnytsia, Ukraine, 21005
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Not yet recruiting
Vinnytsia, Ukraine, 21005
Minicipal Institution City Hospital #7 Recruiting
Zaporizhzhia, Ukraine, 69118
United Kingdom
Department of Gastroenterology, Old Building Recruiting
Bristol, England, United Kingdom, BS2 8HW
NWLH NHS trust Not yet recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
The North West London Hospitals NHS Trust Not yet recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Norfolk and Norwich University Hospital Not yet recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Cambridge University Hospitals NHS Foundation Trust Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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 20, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014