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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 September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01458574
First received: October 21, 2011
Last updated: September 22, 2014
Last verified: September 2014
  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: April 2016
Estimated Primary Completion Date: March 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
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
Horizon Research Group, Inc. Recruiting
Mobile, Alabama, United States, 36608
Internal Medicine Center, LLC Recruiting
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Desert Sun Clinical Research Not yet recruiting
Tucson, Arizona, United States, 85710
Desert Sun Gastroenterology Not yet recruiting
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center Not yet 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 Not yet recruiting
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center Not yet recruiting
Los Angeles, California, United States, 90048
Alliance Clinical Research Recruiting
Oceanside, California, United States, 92056
Homan A Zadeh, MD, MPH Terminated
Palm Springs, California, United States, 92262
Desert Advanced Imaging Terminated
Palm Springs, California, United States, 92262
Erik Palmer, DO Terminated
Palm Springs, California, United States, 92262
Clinical Applications Laboratories, Inc. Recruiting
San Diego, California, United States, 92103
Sharp Rees-Stealy Gastroenterology Recruiting
San Diego, California, United States, 92101
Sharp Rees-Stealy Medical Group, Inc. Recruiting
San Diego, California, United States, 92101
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
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
United States, Connecticut
Bristol Hospital Recruiting
Bristol, Connecticut, United States, 06010
Connecticut Clinical Research Foundation Recruiting
Bristol, Connecticut, United States, 06010
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Yale New Haven Hospital Not yet recruiting
New Haven, Connecticut, United States, 06510
Yale University School of Medicine - Dept of Internal Medicine/Section of Digestive Diseases Not yet recruiting
New Haven, Connecticut, United States, 06510
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 Recruiting
Orange Park, Florida, United States, 32073
Orange Park Surgery Center 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 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
Zephyhills, Florida, United States, 335452
Florida Medical Clinic, P.A. Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Georgia Endoscopy Center Recruiting
Alpharetta, Georgia, United States, 30005
Atlanta Gastroenterology Associates Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology Associates LLC Not yet recruiting
Atlanta, Georgia, United States, 30342
Atlanta Gastroenterology Associates, LLC. Not yet recruiting
Atlanta, Georgia, United States, 30342
Cardiovascular Specialist Not yet recruiting
Atlanta, Georgia, United States, 30342
GI Consultants 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 Recruiting
Johns Creek, Georgia, United States, 30097
Gastroenterology Associates of Central Georgia, LLC Recruiting
Macon, Georgia, United States, 31201
Atlanta Gastroenterology Associates Recruiting
Suwanee, Georgia, United States, 30024
Johns Creek Diagnostic Center 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
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research Not yet recruiting
Chevy Chase, Maryland, United States, 20815
Howard County GIDC Recruiting
Columbia, Maryland, United States, 21044
United States, Michigan
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109-5000
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
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Surgery Center of Columbia Not yet recruiting
Columbia, Missouri, United States, 65201
Hannibal Regional Hospital Not yet recruiting
Hannibal, Missouri, United States, 63401
Audrian Medical Center Not yet recruiting
Mexico, Missouri, United States, 65265
Center for Digestive & Liver Disease, Inc. Not yet recruiting
Mexico, Missouri, United States, 65265
United States, New Jersey
AGA Clinical Research Associates, LLC Recruiting
Egg Harbour Township, New Jersey, United States, 08234
South Jersey Gastroenterology Not yet recruiting
Marlton, New Jersey, United States, 08053
The Gastroenterology Group of South Jersey Not yet 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
Department of Medicine, Clinical Trials Office Recruiting
New York, New York, United States, 10029
Kornbluth, Legnani, George MD, PC Recruiting
New York, New York, United States, 10128
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, Steinlauf and Marion Recruiting
New York, New York, United States, 10028
University of Rochester Not yet recruiting
Rochester, New York, United States, 14642
United States, North Carolina
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
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd. Terminated
Lancaster, Pennsylvania, United States, 17604
Donald Guthrie Foundation for Education and Research Not yet recruiting
Sayre, Pennsylvania, United States, 18840
Guthrie Medical Group, P.C. and Robert Packer Hospital Not yet recruiting
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
Vanderbilt University Medical Center - Laboratory (Chest X-Ray) Not yet recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - GCRC Not yet recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - GI Research Office Not yet recruiting
Nashville, Tennessee, United States, 37212
Vanderbilt University Medical Center - Heart Station Not yet recruiting
Nashville, Tennessee, United States, 37232
Vanderbilt University Medical Center - IBD Clinic Not yet recruiting
Nashville, Tennessee, United States, 37212
Vanderbilt University Medical Center - Drug Shipment Not yet recruiting
Nashville, Tennessee, United States, 37232
United States, Texas
Austin Gastroenterology PA/Austin Endoscopy Center II Active, not recruiting
Austin, Texas, United States, 78745
Professional Quality Research, Inc.- Austin Gastroenterology PA. Active, not recruiting
Austin, Texas, United States, 78705
Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Digestive Disease Center Memorial Hermann Medical Plaza 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 Health 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 Not yet recruiting
Garron, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Royal Prince Alfred Hospital Not yet recruiting
Camperdown, New South Wales, Australia, 2050
Concord Repatriation General Hospital Recruiting
Concord, New South Wales, Australia, 2139
Nepean Hospital Not yet recruiting
Kingswood, New South Wales, Australia, 2747
Pharmacy Department Not yet recruiting
Kingswood, New South Wales, Australia, 2747
Liverpool Hospital Eastern Campus Recruiting
Liverpool, New South Wales, Australia, 2170
Pharmacy Department Recruiting
Liverpool, New South Wales, Australia, 2170
Australia, South Australia
Pharmacy department Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Eastern Health Recruiting
Box Hill, Victoria, Australia, 3128
Monash Medical Centre Recruiting
Clayton, Victoria, Australia, 3168
Austria
AKH Wien, Universitaetsklinik fuer Innere Medizin III Recruiting
Wien, Vienna, Austria, 1090
AKH Wien, Universitaetsklinik fuer Innere Medizin III, Klinische Abteilung fuer Gastroenterologie un Recruiting
Wien, Vienna, Austria, 1090
Medizinische Universität Innsbruck Not yet recruiting
Innsbruck, Austria, A-6020
Belgium
University Hospital Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3000
GastHuisZusters Antwerpen St Vincentius Pharmacy Recruiting
Antwerpen, Belgium, 2018
GZA St. Vincentius Recruiting
Antwerpen, Belgium, 2018
AZ Groeninge Not yet recruiting
Kortrijk, Belgium, 8500
Universitaire Ziekenhuizen (UZ) Leuven Pharmacy Recruiting
Leuven, Belgium, 3000
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
Brazil
Hospital de Clinicas de Porto Alegre - HCPA Not yet recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Hospital Universitario Clementino Fraga Filho/UFRJ Not yet 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
Hamilton Health Sciences Corporation Not yet recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Robarts Clinical Trials - Robarts Research Institute Recruiting
London, Ontario, Canada, N6A 5K8
London Health Science Centre - University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Maisonneuve-Rosemont Hospital Not yet recruiting
Montreal, Quebec, Canada, H1T 2M4
McGill University Health Centre - Royal Victoria Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
Saskatoon City Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Royal University Hospital Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Colombia
Centra Integral de Reumatologia REUMALAB S.A.S. Recruiting
Medellin, Antioquia, Colombia
Hospital Pablo Tobon Uribe Not yet recruiting
Medellin, Antioquia, Colombia, 4459000
Instituto de Coloproctología ICO S.A.S. Recruiting
Medellin, Antioquia, Colombia, 00000
Unidad de Gastroenterologia y Endoscopia Digestiva S.A. - UGASEND S.A. Not yet recruiting
Barranquilla, Atlantico, Colombia, 00000
Croatia
University Hospital Rijeka, Department of Gastroenterology and Hepatology Not yet recruiting
Rijeka, Croatia, 51000
General Hospital Zadar Not yet recruiting
Zadar, Croatia, 23 000
Clinical Hospital Center Zagreb Clinic For Internal Medicine Not yet recruiting
Zagreb, Croatia, 11000
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. Not yet recruiting
Praha 6 - Stresovice, Czech Republic, 169 00
Klinicke Centrum ISCARE I.V.F. Not yet recruiting
Praha 7, Czech Republic, 170 04
Poliklinika Prosek, Pneumologie Not yet 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/Department of Gastroenterology 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 - Department of Medical Gastroenterology Not yet recruiting
Hvidovre, Denmark, 2650
Odense University Hospital Recruiting
Odense C, Denmark, 5000
Estonia
Ida-Viru Central Hospital Not yet recruiting
Kohtla-Jarve, Estonia, 30322
X-Ray Unit of East Viru Central Hospital Not yet recruiting
Kothla Jarve, Estonia, 30322
ECG Unit of East Viru Central Hospital Not yet recruiting
Kothla Järve, Estonia, 30322
ECG Unit of West Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10617
ECG Unit, East Tallinn Central Hospital Recruiting
Tallinn, Estonia, 10138
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 Tallin Central Hospital Recruiting
Tallinn, Estonia, 10138
Tartu University Hospital Division of Endocrinology and Gastroenterology Not yet recruiting
Tartu, Estonia, 51014
France
Hopital Saint-Louis Not yet 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 Recruiting
Clichy Cedex, France, 92110
Hotel-Dieu CHU Nantes Recruiting
Nantes cedex 01, France, 44093
Hopital Saint Antoine - Service de Gastroenterologie Recruiting
Paris cedex 12, France, 75571
CHU de Reims - Pharmacie Not yet recruiting
Reims Cedex, France, 51092
C.H.U. de Reims - Hôpital Robert Debré Not yet recruiting
Reims cedex, France, 51092
Hopital Nord Recruiting
Saint Priest en Jarez, France, 42270
Hôpital Rangueil - Service Pharmacie Essais Cliniques Not yet recruiting
Toulouse Cedex 09, France, 31059
Hôpital Rangueil Not yet recruiting
Toulouse Cedex 9, France, 31059
Germany
Charite Campus Virchow-Klinikum Universitaetsmedizin Berlin Medizinische Klinik mit Schwerpunkt Gast Not yet recruiting
Berlin, Germany, 13353
Klinikum der Wolfgang Goethe-Universitat, Medizinische Klinik 1, Haus 11, 3. Stock Not yet recruiting
Frankfurt, Germany, 60596
Klinikum der Wolfgang Goethe-Universitat Not yet recruiting
Frankfurt, Germany, 60596
Universitaetsklinikum Halle (Saale) Recruiting
Halle, Germany, 06097
Medizinishce Hochschule hannover Recruiting
Hannover, Germany, 30625
Universitaetsklinikum Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
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
Szent Pantaleon Kórház Not yet recruiting
Dunaújváros, Europe, Hungary, Hungary, H-2400
Dr. Rethy Pal Korhaz-Rendelointezet/III. Belgyogyaszat Recruiting
Bekescsaba, Hungary, H-5600
Szent Margit Korhaz - III Belgyogyaszat Recruiting
Budapest, Hungary, H-1032
Magyar Honvedseg Egeszsegugyi Kozpont Not yet recruiting
Budapest, Hungary, 1134
Pannonia Maganorvosi Centrum Kft. Recruiting
Budapest, Hungary, H-1136
Peterfy Sandor utcai Korhaz Recruiting
Budapest, Hungary, H-1076
Szent Janos Korhaz és Eszak-budai egyesített Korhazak I Belgyogyaszat Recruiting
Budapest, Hungary, H-1125
Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-Budai Egyesitett Korhazai Not yet recruiting
Budapest, Hungary, H-1125
Bekes Megyei Pandy Kalman Korhaz, III Gasztroenterologiai Osztaly Recruiting
Gyula, Hungary, 5700
Somogy Megyei Kaposi Mor Oktato Korhaz Not yet recruiting
Kaposvar, Hungary, H-7400
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, II. Belgyógyászat Not yet recruiting
Miskolc, Hungary, H-3526
Karolina Korhaz Rendelointezet Belgyogyaszat Gastroenterologia Hungary Not yet recruiting
Mosonmagyarovar, Hungary, H-9200
Pecsi Tudomanyegyetem Klinikai Kozpont Recruiting
Pecs, Hungary, H-7624
Szegedi Tudomanyegyetem Szent- Gyorgyi Albert Klinika Kozpont Recruiting
Szeged, Hungary, H6720
Javorszky Odon Korhaz Not yet recruiting
Vac, Hungary, H2601
Israel
Bnai Zion Medical Center (Bzmc), The Ruth And Bruce Rappaport Faculty Of Medicine Not yet recruiting
Haifa, Israel, 31999
Bnai Zion Medical Center/ Gastroenterology Institute Not yet recruiting
Haifa, Israel, 31048
Gastroenterology Institute Not yet recruiting
Haifa, Israel, 31048
Rambam Health Care Center Not yet recruiting
Haifa, Israel, 31096
The Edith Wolfson Medical Center/Gastroenterology Department Not yet recruiting
Holon, Israel, 58100
Rabin Medical Center, Beilinson campus Not yet recruiting
Petah Tikva, Israel, 49100
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Italy
Centro di Riferimeno Oncologico Not yet recruiting
Aviano, PN, Italy, 33081
University of Catanzaro "Magna Graecia" Recruiting
Catanzaro, Italy, 88100
Ospedali Riuniti Villa Sofia Cervello University of Palermo Recruiting
Palermo, Italy, 90146
Farmacia Istituto Clinico Humanitas IRCCS Recruiting
Rozzano (MI), Italy, 20089
Istituto Clinico Humanitas IRCCS - IBD Center Recruiting
Rozzano (MI), Italy, 20089
Japan
Aichi Medical University Hospital Recruiting
Nagakute, Aichi, Japan, 480-1195
National Hospital Organization Hirosaki National Hospital Recruiting
Hirosaki, Aomori, Japan, 0368545
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
Susaki Kuroshio Hospital Recruiting
Susaki, Kochi, 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
Tokyo Medical And Dental University Hospital, Faculty of Medicine Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8519
Jikei University Hospital Recruiting
Minato-ku, Tokyo, Japan, 105-8471
Keio University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Toho University Sakura Medical Center Recruiting
Chiba, Japan, 285-8741
Chiba University Hospital Recruiting
Chiba, Japan, 260-8677
Fukuoka University Chikushi Hospital Recruiting
Fukuoka, Japan, 818-8502
Kurume University Hospital Recruiting
Fukuoka, Japan, 830-0011
Hiroshima University Hospital Recruiting
Hiroshima, Japan, 734-8551
Kuniyoshi Hospital Recruiting
Kochi, Japan, 780-0901
Kyoto University Hospital Not yet recruiting
Kyoto, Japan, 606-8507
Ikime Large Intestine Anus Surgery Internal Medicine Recruiting
Miyazaki, Japan, 880-2104
Osaka City University Hospital Recruiting
Osaka, Japan, 545-8586
Japan Community Health care Organization Tokyo Yamate Medical Center Recruiting
Tokyo, Japan, 169-0073
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
Korea, Republic of
Pusan National University Hospital, Clinical Laboratory Not yet recruiting
Seo-Gu, Busan, Korea, Republic of, 602-739
Hanyang University Guri Hospital Recruiting
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
CHA Bundang Medical Center, CHA University Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Kyung Hee University Hospital, Clinical Laboratory Recruiting
Dongdaemun-gu, Seoul, Korea, Republic of, 130-872
Pusan National University Hospital Not yet recruiting
Busan, Korea, Republic of, 602-739
Gachon University Gil Hospital, Clinical Laboratory Not yet recruiting
Incheon, Korea, Republic of, 405-760
Gachon University Gil Hospital Not yet recruiting
Incheon-si, Korea, Republic of
Severance Hospital, Yonsei University Health System Not yet 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 Not yet 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
Digestive Diseases Center GASTRO Recruiting
Riga, Latvia, LV1006
ECG Unit, 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
Netherlands
Academic Medical Center (AMC) Recruiting
Amsterdam, Netherlands, 1105 AZ
VU University Medical Center (VUMC) Recruiting
Amsterdam, Netherlands, 1081 HV
University Medical Center Groningen (UMCG) Recruiting
Groningen, Netherlands, 9713 GZ
University Medical Center Groningen, Hospital and Clinical Pharmacy Recruiting
Groningen, Netherlands, 9713 AP
Leiden University Medical Center (LUMC) Not yet recruiting
Leiden, Netherlands, 2333 ZA
Apotheek dep. KGO (pharmacy) UMC Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
UMC Utrecht (IP shipments) Not yet recruiting
Utrecht, Netherlands, 3584 CW
University Medical Center(UMC) Utrecht Not yet recruiting
Utrecht, Netherlands, 3584 CX
New Zealand
Shakespeare Specialist Group Not yet recruiting
Milford, Auckland, New Zealand, 0620
Biomedical Systems Recruiting
Brussels, Belgium, New Zealand
Robarts Clinical Trials Recruiting
Ontario, Canada, New Zealand, N6A 5K8
Auckland District Health Board, Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
LabPlus (Local Lab) Recruiting
Auckland, New Zealand, 1010
Canterbury Health Laboratories (Local Lab) Recruiting
Christchurch, New Zealand, 8011
Christchurch Hospital DR RICHARD GEARRY Recruiting
Christchurch, New Zealand, 8011
Southern District Health Board Recruiting
Dunedin, New Zealand, 9016
Waikato District Health Board Recruiting
Hamilton, New Zealand
Waikato Hospital Laboratory (Local Lab) Recruiting
Hamilton, New Zealand, 3240
Quintiles East Asia Pte Ltd Recruiting
Singapore, New Zealand, 18264
Pathlab BOP Clinical School Recruiting
Tauranga, New Zealand, 3143
Aotea Pathology (Local Lab) Recruiting
Wellington, New Zealand, 6011
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
Gabinet Lekarski-Janusz Rudzinski Recruiting
Bydgoszcz, WOJ.Kujawsko-Pomorskie, Poland, 85-681
Oddzial Chorob Wewnetrznych i Gastroenterologii, Not yet recruiting
Bialystok, Poland, 15-950
10 Wojskowy Szpital Kliniczny z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej 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 Not yet recruiting
Lodz, Poland, 90-153
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego Not yet recruiting
Lodz, Poland, 90-153
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego Zaklad Radiologii Not yet recruiting
Lodz, Poland, 90-153
Endoskopia SP. Z O.O. Recruiting
Sopot, Poland, 81-756
Centralny Szpital Kliniczny Mswia W Warszawie Recruiting
Warszawa, Poland, 02507
Centrum Badawcze Wspolczesnej Terapii Not yet recruiting
Warszawa, Poland, 02-679
Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob Zapalnyc 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
Policlinica Dr. Citu/Internal medicine, gastroenterology Not yet recruiting
Timisoara, Timis, Romania, 300593
Spitalul Clinic Judetean de Urgenta Timisoara Not yet recruiting
Timisoara Jud Timis, Timis, Romania, 300736
Endocenter Medicina Integrativa Not yet recruiting
Bucharest, Romania, 021978
Spitalul Universitar de Urgenta Recruiting
Bucharest, Romania, 050098
Emergency Universitary County Hospital Tg. Mures Not yet recruiting
Targu Mures, Romania, 540136
Spitalul Clinic Judetean de Urgenta Targu Mures Not yet recruiting
Targu Mures, Jud. Mures, Romania, 540136
Cabinet Particular Policlinic Algomed Srl Recruiting
Timisoara, Romania, 300002
Russian Federation
State budget institution of healthcare of Stavropol region "City Clinical Hospital of Pyatigorsk" Not yet recruiting
Pyatigorsk, Stavropol region, Russian Federation, 357500
State budget Healthcare Institution Moscow regional scientific research clinical institute Not yet recruiting
Moscow, Russian Federation, 129110
Federal state budget institution "State scientific centre of coloproctology" Recruiting
Moscow, Russian Federation, 123423
State Institution of Healthcare Nizhniy Novgorod Regional Clinical Hosp named after N.A. Semashko Recruiting
Nizhniy Novgorod, Russian Federation, 603126
Novosibirsk State Medical University Recruiting
Novosibirsk, Russian Federation, 630091
City Clinical Hospital #12 Recruiting
Novosibirsk, Russian Federation, 630084
Clinical Hospital #2 Not yet recruiting
Popova str., Russian Federation, 150010
2. GUZ City Hospital # 26 Not yet recruiting
Saint Petersburg, Russian Federation
GBOU VPO "Northwest State Medical University n.a. I.I. Mechnikov" Not yet recruiting
Saint Petersburg, Russian Federation
Limited Liability Company Medical Company "Hepatolog" Recruiting
Samara, Russian Federation, 443093
Municipal institution of healthcare "City clinical hospital 12" Recruiting
Saratov, Russian Federation, 410039
State budget institution of healthcare of Yaroslavl region Regional clinical hospital Recruiting
Yaroslavl, Russian Federation, 150062
OOO Medical Center of Diagnostics and Prophylaxis "Sodruzhestvo" Not yet recruiting
Yaroslavl, Russian Federation, 150040
Yaroslavl State Medical Academy Not yet recruiting
Yaroslavl, Russian Federation, 150000
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 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 "Djordje Joanovic" 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
Pro RTG s. r. o. Not yet recruiting
Bratislava, Slovakia, 811 07
Fakultna nemocnica Nitra, Ustav klinickej mikrobiologie Not yet recruiting
Nitra, Slovakia, 950 01
Jessenius - diagnosticke centrum a.s. Not yet recruiting
Nitra, Slovakia, 949 01
ProCare Medicinske centrum Nitra/Gastroenterologicka Ambulancia Not yet 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
Jessenius - diagnosticke centrum a.s. 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
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
Cape Town, Western Cape, South Africa, 7646
Dr JP Wright Recruiting
Claremont, Cape Town, South Africa, 7708
Spain
Hospital Universitario de Fuenlabrada/Departamento de Gastroenterologia Not yet recruiting
Fuenlabrada, Madrid, Spain, 28942
Hospital Universitario de Bellvitge Not yet recruiting
Barcelona, Spain, 08907
Corporacio Sanitaria Parc Tauli Not yet recruiting
Barcelona, Spain, 08208
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Clinico San Carlos Dr Carlos Taxonera C/Profesor Martin Lagos Recruiting
Madrid, Spain, 28040
Hospital Universitario de La Princesa/Unidad de Gastroenterologia/Hepatologia Not yet recruiting
Madrid, Spain, 28006
Taiwan
Chung Shan Medical University Hospital Not yet recruiting
Taichung, R.o.c., Taiwan, 40201
Biomedical Systems Recruiting
Belgium, Taiwan
Biomedical Systems Not yet recruiting
Belgium, Taiwan
Robart Clinical Trial Recruiting
Canada, Taiwan
Robart Clinical Trial Not yet recruiting
Canada, Taiwan
Quintiles East Asia Pte Ltd Not yet recruiting
Singapore, Taiwan, 118264
Quintiles East Asia Pte Ltd Recruiting
Singapore, Taiwan, 118264
National Taiwan University Hospital, Department of Laboratory Medicine: Recruiting
Taipei, Taiwan, 100
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Chang Gung Memorial Foundation - LinKou Branch Not yet recruiting
Taoyuan County, Taiwan, 333
Chang Gung Memorial Foundation - LinKou Branch, Laboratory Not yet recruiting
Taoyuan County, Taiwan, 333
Ukraine
Local Laboratory of I.M.C. of Crimean Republic Institution Recruiting
Simferopol, AR Krym, Ukraine, 95017
InternalMedicineCenterofCrimean RepublicInstitution"ClinicalTerritorialMedicalCommunity Recruiting
Simferopol, AR Krym, Ukraine, 95017
Regional Municipal Institution Chernivtsi Regional Clinical Hospital Recruiting
Chernivtsi, Ukraine, 58001
Local laboratory of Regional Municipal Institution ¿Chernivtsi Regional Clinical Hospital¿ Recruiting
Chernivtsi, Ukraine, 58001
State Institution "Institute of Gastroenterology of the National Academy of Medical Sciences of Not yet 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 Medical Sciences of Recruiting
Kharkov, 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
Municipal City Clinical Hospital of the Emergency Medical Care, Recruiting
Lviv, Ukraine, 79059
State Institution District Clinical Hospital of Uzhgorod station Recruiting
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War, Therapy Department #2, Recruiting
Vinnytsia, Ukraine, 21005
Local Laboratory of Medical Diagnostic Center 'Slaomed' Not yet recruiting
Vinnytsia, Ukraine, 21029
Local Laboratory of Vinnytsia Regional Clinical Hospital for Invalids of the Great Patriotic War Recruiting
Vinnytsia, Ukraine, 21005
"Health Clinic LLC" based on of Medical Diagnostic Center "Slaomed" "Slaomed" LLC", Not yet recruiting
Vinnytsia, Ukraine, 21029
Minicipal Institution City Hospital 7, Therapevtic Department, Recruiting
Zaporizhzhia, Ukraine, 69118
United Kingdom
Norfolk and Norwich University Hospital Not yet recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Department of Gastroenterology, Old Building Not yet recruiting
Bristol, United Kingdom, BS2 8HW
Addenbrooke's Hospital, Recruiting
Cambridge, United Kingdom, CB2 0QQ
University College London Hospitals NHS Foundation Trust Not yet 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: NCT01458574     History of Changes
Other Study ID Numbers: A3921096, 2011-004580-79, OCTAVESUSTAIN
Study First Received: October 21, 2011
Last Updated: September 22, 2014
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
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 25, 2014