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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01458574
First received: October 21, 2011
Last updated: May 18, 2016
Last verified: May 2016
  Purpose
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.

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

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Estimated Enrollment: 654
Study Start Date: July 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Comparator Drug: Placebo
Placebo 10 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 5 mg Arm Drug: CP690,550
CP-690,550 5 mg orally (PO) twice a day (BID)
Experimental: CP-690,550 10 mg Arm Drug: CP-690,550
CP-690,550 10 mg orally (PO) twice a day (BID)

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
  • Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

  Hide Study Locations
Locations
United States, Alabama
Internal Medicine Center, LLC Recruiting
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital (Endoscopy Only) Recruiting
Mobile, Alabama, United States, 36608
United States, California
UCSD Medical Center Recruiting
La Jolla, California, United States, 92093
UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center Recruiting
La Jolla, California, United States, 92037-0845
Alliance Clinical Research Recruiting
Oceanside, California, United States, 92056
Desert Advanced Imaging Recruiting
Palm Springs, California, United States, 92262
Erik Palmer, DO Recruiting
Palm Springs, California, United States, 92262
Homan A Zadeh, MD, MPH Recruiting
Palm Springs, California, United States, 92262
Sharp Rees-Stealy Medical Group Recruiting
San Diego, California, United States, 92123
Sharp Rees-Stealy Medical Group, Inc. Recruiting
San Diego, California, United States, 92101
Clinical Applications Laboratories, Inc Recruiting
San Diego, California, United States, 92103
San Diego Endoscopy Center Recruiting
San Diego, California, United States, 92103
Medical Center at Mount Zion Recruiting
San Francisco, California, United States, 94115
UCSF Endoscopy Unit at Mount Zion Recruiting
San Francisco, California, United States, 94115
University of California San Francisco 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
Central Connecticut Endoscopy Center Recruiting
Plainville, Connecticut, United States, 06062
United States, Florida
Citrus Surgery & Endoscopy Center (colonoscopy) Recruiting
Crystal River, Florida, United States, 34429
Nature Coast Clinical Research Recruiting
Inverness, Florida, United States, 34452
Suncoast Endoscopy Center (colonoscopy) Recruiting
Inverness, Florida, United States, 34453
North Florida Gastroenterology Research, LLC Recruiting
Orange Park, Florida, United States, 32073
Orange Park Surgery Center Recruiting
Orange Park, Florida, United States, 32073
Citrus Ambulatory Surgery Center Recruiting
Orlando, Florida, United States, 32806
Internal Medicine Specialists Recruiting
Orlando, Florida, United States, 32806
Advanced Medical Research Center Recruiting
Port Orange, Florida, United States, 32127
Advanced Gastroenterology 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
Zephyhills, Florida, United States, 33542
Florida Medical Clinic, P.A. Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center (COLONOSCOPY) Recruiting
Alpharetta, Georgia, United States, 30005
GI Consultants (COLONOSCOPY) Recruiting
Atlanta, Georgia, United States, 30342
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 Recruiting
Suwanee, Georgia, United States, 30024
Johns Creek Diagnostic Center (XRAY) 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
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
Howard County GIDC Recruiting
Columbia, Maryland, United States, 21044
United States, Michigan
Medical Science Research Building 1 - University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
East Ann Arbor Health and Geriatrics Center - University of Michigan Health Systems 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 - Univeristy of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5872
Saint Joseph Mercy Hospital - Inpatient Pharmacy (drug ship only) Recruiting
Ann Arbor, Michigan, United States, 48106
Clinical Research Institute of Michigan, LLC Recruiting
Chesterfield, Michigan, United States, 48047
Surgical Centers of Michigan Recruiting
Troy, Michigan, United States, 48098
Center for Digestive Health 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 Recruiting
Rochester, Minnesota, United States, 55905
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
AGA Clinical Research Associates, LLC Recruiting
Egg Harbour Township, New Jersey, United States, 08234
South Jersey Gastroenterology Recruiting
Marlton, New Jersey, United States, 08053
The Endo Center at Voorhees Recruiting
Vorhees, New Jersey, United States, 08043
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
Present, Chapman, Marion, Steinlauf, Lichtiger MD, PC Recruiting
New York, New York, United States, 10028
The Private Practice of Simon Lichtiger, MD Recruiting
New York, New York, United States, 10028
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Mount Sinai School of Medicine Faculty Practice Associates Recruiting
New York, New York, United States, 10029
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
CUMC Research Pharmacy (drug ship 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 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, 44195-0001
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd. Terminated
Lancaster, Pennsylvania, United States, 17604
United States, Texas
Professional Quality Research, Inc.- Austin Gastroenterology PA. Recruiting
Austin, Texas, United States, 78705
Austin Gastroenterology PA/Austin Endoscopy Center II Recruiting
Austin, Texas, United States, 78745
Memorial Hermann Hospital - Ertan Digestive Disease Center Recruiting
Houston, Texas, United States, 77030
Baylor College of Medicine (Baylor Medical Center) Recruiting
Houston, Texas, United States, 77030
Baylor College of Medicine - Baylor Medical Center (Drug Storage) Recruiting
Houston, Texas, United States, 77030
Houston Hospital for Specialized Surgery (Endoscopy only) Recruiting
Houston, Texas, United States, 77004
The University of Texas at 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 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
The Center for Digestive Health Recruiting
Milwaukee, Wisconsin, United States, 53215
Wisconsin Center for Advanced Research - GI Associates, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Australia, New South Wales
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
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 Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Australia
Liverpool Hospital Recruiting
NSW, Australia, 2171
Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Vienna, Austria, 1090
Belgium
GZA St. Vincentius Recruiting
Antwerpen, Belgium, 2018
Biomedical Systems Recruiting
Brussels, Belgium, 1160
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
UZ Leuven (University Hospital Leuven), Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
H-Hartziekenhuis Roeselare-Menen vzw Recruiting
Roeselare, Belgium, 8800
Brazil
Hospital de Clinicas de Porto Alegre - HCPA Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-003
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Canada, Alberta
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, L8N 3Z5
London Health Sciences Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal General Hospital - McGill University Health Centre 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 Coloproctología ICO S.A.S. Recruiting
Medellin, Antioquia, Colombia, 00000
Laboratorio Clinico y Reumatologico Reumalab Recruiting
Medellin, Antioquia, Colombia
Quintiles, Ltd. Recruiting
Marietta, GA, Colombia, 30067
Robarts Clinical Trials Recruiting
London, Canada, Colombia
Croatia
University Hospital Center Zagreb Recruiting
Zagreb, Croatia, 10 000
Czech Republic
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Kralove, Czech Republic, 500 12
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
Bispebjerg Hospital Recruiting
Copenhagen, NV, Denmark, 2400
Aalborg Hospital Recruiting
Aalborg, Denmark, 9000
Aalborg Hospital Recruiting
Aalborg, Denmark, 9100
Aarhus University Hospital Department of Hepato Gastroenterrology V Aarhus Recruiting
Aarhus C, Denmark, 8000
Hvidovre Hospital Recruiting
Hvidovre, Denmark, 2650
Odense University Hospital Recruiting
Odense C, Denmark, 5000
Estonia
X-Ray Department of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
Innomedica OU Recruiting
Tallinn, Estonia, 10117
East Tallinn Central Hospital Internal Medicine Clinic Recruiting
Tallinn, Estonia, 10138
ECG Unit of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
Internal Medicine Clinic Recruiting
Tallinn, Estonia, 10617
Mammograaf OU (Endoscopy Only) Recruiting
Tallinn, Estonia, 13419
ECG Unit, Innomedica OU and Qualitas AS (ECG Only) Recruiting
Tallinn, Estonia, 10117
France
CHU Amiens PICARDIE - Hopital SUD Recruiting
Amiens Cedex 1, France, 80054
Hopital Saint Andre Recruiting
Bordeaux cedex, France, 33075
Hopital Beaujon Recruiting
Clichy Cedex, France, 92110
Hotel-Dieu CHU Nantes Recruiting
Nantes cedex 01, France, 44093
Hopital Saint Louis - Service d'hepato-gastoenterologie Recruiting
Paris, France, 75010
Hopital Saint Louis Recruiting
Paris, France, 75010
Hopital Saint Antoine - Service de Gastroenterologie Recruiting
Paris cedex 12, France, 75571
C.H.U. de Reims - Hôpital Robert Debré Recruiting
Reims cedex, France, 51092
Hopital Nord Recruiting
Saint Priest en Jarez, France, 42270
Germany
Universitaetsklinikum Ulm Recruiting
Ulm, Baden-wurttemberg, Germany, 89081
Universitaetsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Schlewig Holstein, Germany, 24105
Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Recruiting
Berlin, Germany, 13353
Universitaetsklinikum Halle 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
Hungary
Dr Rethy Pal Korhaz-Rendelointezet, III Belgyogyaszat Recruiting
Bekescsaba, Hungary, 5600
Szent Margit Korhaz - III Belgyogyaszat Recruiting
Budapest, Hungary, H-1032
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak Recruiting
Budapest, Hungary, 1125
Pannonia Maganorvosi Centrum Kft. Recruiting
Budapest, Hungary, H-1135
Peterfy Sandor Utcai Korhaz Rendelointezet es Baleseti Kozpont Recruiting
Budapest, Hungary, 1076
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet Gasztroenterologiai Tanszek 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 Recruiting
Miskolc, Hungary, 3526
Karolina Korhaz Recruiting
Mosonmagyarovar, Hungary, 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 Recruiting
Vac, Hungary, 2600
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Rabin Medical Center, Beilinson campus Recruiting
Petah Tikva, Israel, 49100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Italy
Istituto Clinico Humanitas IRCSS Recruiting
Rozzano, Milano, Italy, 20089
AOU Mater Domini Recruiting
Catanzaro, Milan, Italy, 88100
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
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
Sameshima Hospital Recruiting
Kagoshima-shi, Kagoshima, Japan, 892-0846
Kuniyoshi Hospital Recruiting
Kochi-shi, Kochi, Japan, 780-0901
National Hospital Organization Sendai Medical Center Recruiting
Sendai, Miyagi, Japan, 983-8520
Osaka Medical College Hospital Recruiting
Takatsuki, Osaka, Japan, 569-8686
Shiga University of Medical Science Hospital Recruiting
Otsu-shi, Shiga, Japan, 520-2192
Tokyo Medical And Dental University Hospital, Faculty of Medicine Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Tokai University Hachioji Hospital Recruiting
Hachioji, Tokyo, Japan, 192-0032
Kitasato University Kitasato Institute Hospital Recruiting
Minato-ku, Tokyo, Japan, 108-8642
NTT Medical Center Tokyo Recruiting
Shinagawa-ku, Tokyo, Japan, 141-8625
Showa University Hospital Recruiting
Shinagawa-ku, Tokyo, Japan, 142-8666
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
Kurume University Hospital Recruiting
Fukuoka, Japan, 830-0011
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
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 Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital, Recruiting
Seoul, Korea, Republic of, 110-744
Kyung Hee University Hospital / Department of Gastroenterology Recruiting
Seoul, Korea, Republic of, 130-872
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Latvia
ECG room Clinic Linezers (ECG only) Riga East University Hospital Recruiting
Riga, Latvia, LV-1006
X-Ray Department, Clinic Linezers (radiology only) Recruiting
Riga, Latvia, LV-1006
Digestive Diseases Center GASTRO Recruiting
Riga, Latvia, LV1006
Netherlands
Leiden University Medical Center (LUMC) Recruiting
Leiden, ZH, Netherlands, 2333 ZA
VU University Medical Center (VUMC) Recruiting
Amsterdam, Netherlands, 1081 HV
Academic Medical Centre Recruiting
Amsterdam, Netherlands, 1105 AZ
University Medical Center Groningen (UMCG) Recruiting
Groningen, Netherlands, 9713 GZ
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, Canterbury Region, 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
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
Gabinet Lekarski - Janusz Rudzinski Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-681
Klinika Chorob Wewnetrznych i Gastroenterologii z Recruiting
Warszawa, Mazowieckie, Poland, 02-507
H-T. Centrum Medyczne - ENDOTERAPIA Recruiting
Tychy, Slaskie, Poland, 43-100
Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych, Recruiting
Bydgoszcz, Poland, 85-168
Gabinet Endoskopii Przewodu Pokarmowego Recruiting
Krakow, Poland, 31-009
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Recruiting
Lodz, Poland, 90-153
Endoskopia Sp. Z O.O. Recruiting
Sopot, Poland, 81-756
Nzoz Vivamed Recruiting
Warszawa, Poland, 03-580
Lexmedica Recruiting
Wroclaw, Poland, 53-114
Romania
Spitalul Universitar de Urgenta Bucuresti, Sectia De Medicina Intema II si Gastroenterologie Recruiting
Bucuresti, Sector 5, Romania, 050098
Cabinet Particular Policlinic Algomed Srl Recruiting
Timisoara, Timis, Romania, 300002
Russian Federation
Municipal Institution of Healthcare City Clinical Hospital 12, Recruiting
Saratov, Russia, Russian Federation, 410039
Federal state budget institution "State scientific centre of coloproctology" Recruiting
Moscow, Russian Federation, 123423
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
State Budget Educational Institution of Higher Professional Education Recruiting
Novosibirsk, Russian Federation, 630091
Municipal Budget Institution of Healthcare of Novosibirsk " City Clinical Hospital No 12" Recruiting
Novosibirsk, Russian Federation, 630084
Federal state Institution "Sibirian regional Medical centre of Federal Medicobiologic Agency", Recruiting
Novosibirsk,, Russian Federation, 630068
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
State budget institution of healthcare of Yaroslavl region Regional clinical hospital Recruiting
Yaroslavl, Russian Federation, 150062
Serbia
Clinical Centre of Serbia, Clinic for Gastroenterology and Hepatology Recruiting
Belgrade, Serbia, Europe, Serbia, 11000
Clinical Hospital Centre Zvezdara Recruiting
Belgrade, Serbia, 11000
Military Medical Academy Belgrade Recruiting
Belgrade, Serbia, 11000
Clinical Centre of Kragujevac Recruiting
Kragujevac, Serbia, 34000
Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology Recruiting
Novi Sad, Serbia, 21000
Clinical Centre of Vojvodina, Emergency Internal Medicine Division Recruiting
Novi Sad, Serbia, 21000
Slovakia
Medak s.r.o. Recruiting
Bratislava, Slovakia, 851 01
KM Management spol. s.r.o. Recruiting
Nitra, Slovakia, 949 01
Aura SA, s.r.o. Recruiting
Nove Mesto nad Vahom, Slovakia, 91501
Gastro I., s.r.o. Recruiting
Presov, Slovakia
South Africa
Dr John Philip Wright Recruiting
Claremon, Cape Town Western Cape, South Africa, 7708
Chris Hani Baragwanath Academic Hospital Recruiting
Johannesburg, Gauteng, South Africa, 2013
Panorama MediClinic Recruiting
Cape Town, Western Cape, South Africa, 7500
The Loius Leipoldt Medical Centre Alida Thorpe Recruiting
Cape Town, Western Cape, South Africa, 7530
Endocare Research Centre Recruiting
Western Cape, South Africa, 7646
Spain
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Universitari de Bellvitge Recruiting
Barcelona, Spain, 08907
Hospital Universitario de Bellvitge Recruiting
Barcelona, Spain, 08907
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada Recruiting
Madrid, Spain, 28942
Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Ukraine
Internal Medicine Center of Crimean Republic Institution"Clinical Territorial Medical Community" Recruiting
Simferopol, Ar Krym, Ukraine, 95017
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital" Recruiting
Chernivtsi, Ukraine, 58001
Regional Municipal Institution ¿Chernivtsi Regional Clinical Hospital¿, Recruiting
Chernivtsi, Ukraine, 58001
State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of Recruiting
Dniepropetrovsk, Ukraine, 49074
Municipal Healthcare Institution Kharkiv City Clinical Hospital #2, Proctology Department Recruiting
Kharkiv, Ukraine, 61037
State Institution "National L.T. Malaya Therapy Institute of National Academy of Recruiting
Kharkov, Ukraine, 61039
Kyiv City Clinical Hospital 8 Department Of Gastroenterology P L Shupika Recruiting
Kiev, Ukraine, 04201
Kyiv Municipal Clinical Hospital #18, Proctology Department Recruiting
Kyiv, Ukraine, 01030
LTD "St. Paraskeva Medical Center" Recruiting
Lviv, Ukraine, 79019
Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital, Recruiting
Lviv, Ukraine, 79059
SI "Railway Hospital of the SI "Odesa Railway"", Polyclinic Department, Recruiting
Odesa, Ukraine, 65010
Municipal Institution "Odesa Regional Clinical Hospital" Recruiting
Odesa, Ukraine, 65025
SI "Railway Hospital of the State Institution "Odesa Railway" Odesa National Medical University, Recruiting
Odessa, Ukraine, 65010
University Clinic"I. "C.S.M.U. n.a.S.I. Georgiyevskyi", Chair of Therapy and Family medicine Recruiting
Simferopol, Ukraine, 95017
SI "District Clin. Hosp.of Uzhgorod station (STSA "Lviv Railway", Therapy Dep., SBHEI "Uzhgorod Nat. Recruiting
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2, Recruiting
Vinnytsia, Ukraine, 21005
¿Health Clinic LLC¿ based on of Medical Diagnostic Center ¿Slaomed¿ ¿Slaomed¿ LLC", Recruiting
Vinnytsia, Ukraine, 21029
Motor-Sich clinic, LLC Recruiting
Zaporizhzhia, Ukraine, 69068
Minicipal Institution City Hospital 7, Therapevtic Department, Recruiting
Zaporizhzhia, Ukraine, 69118
United Kingdom
Addenbrooke's Hospital-Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
Department of Gastroenterology, Old Building Recruiting
Bristol, England, United Kingdom, BS2 8HW
University College London Hospitals NHS Foundation Trust Recruiting
London, England, United Kingdom, NW1 2PG
NWLH NHS trust Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
The North West London Hospitals NHS Trust Recruiting
Harrow, Middlesex, United Kingdom, HA1 3UJ
Norfolk and Norwich University Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QQ
Clinical Research Facility Recruiting
London, United Kingdom, NW1 2BU
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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01458574     History of Changes
Other Study ID Numbers: A3921096  2011-004580-79  OCTAVESUSTAIN 
Study First Received: October 21, 2011
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2016