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

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01470612
First received: October 21, 2011
Last updated: May 2, 2013
Last verified: May 2013
  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: December 2017
Estimated Primary Completion Date: November 2017 (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
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
Internal Medicine Center, LLC Not yet recruiting
Mobile, Alabama, United States, 36608
Horizon Research Group, Inc. Not yet recruiting
Mobile, Alabama, United States, 36608
Springhill Memorial Hospital Not yet recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Adobe Clinical Research, LLC Not yet recruiting
Tucson, Arizona, United States, 85712
Desert Sun Gastroenterology Not yet recruiting
Tucson, Arizona, United States, 85710
Desert Sun Surgery Center Not yet recruiting
Tucson, Arizona, United States, 85710
Adobe Surgery Center Not yet recruiting
Tucson, Arizona, United States, 85712
Desert Sun Clinical Research Not yet recruiting
Tucson, Arizona, United States, 85710
United States, California
UCSD Medical Center Not yet recruiting
La Jolla, California, United States, 92093
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Southern California Research Institute Medical Group, Inc - West Gastroenterology Medical Group Not yet recruiting
Los Angeles, California, United States, 90045
Cedars-Sinai Medical Center - Inflammatory Bowel Disease Center Recruiting
Los Angeles, California, United States, 90048
West Gastroenterology Medical Group Not yet recruiting
Los Angeles, California, United States, 90813
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Alliance Clinical Research Not yet recruiting
Oceanside, California, United States, 92056
Homan A Zadeh, MD, MPH Not yet recruiting
Palm Springs, California, United States, 92262
Hope Square Surgical Center Not yet recruiting
Rancho Mirage, California, United States, 92270
Sharp Rees-Stealy Medical Group Recruiting
San Diego, California, United States, 92123
San Diego Endoscopy Center Not yet recruiting
San Diego, California, United States, 92103
Sharp Rees-Stealy Medical Group Recruiting
San Diego, California, United States, 92101
University of California - San Francisco Not yet recruiting
San Francisco, California, United States, 94115
United States, Connecticut
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, LLC Recruiting
Hamden, Connecticut, United States, 06518
Medical Research Center of Connecticut, LLC Recruiting
Hamden, Connecticut, United States, 06518
Yale University School of Medicine Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
South Broway Endoscopy Not yet recruiting
Cooper City, Florida, United States, 33026
Southern Clinical Research Consultants Not yet recruiting
Hollywood, Florida, United States, 33021
MNH Surgical Center Not yet recruiting
Maitland, Florida, United States, 32751
Center for Advanced Gastroenterology Not yet recruiting
Maitland, Florida, United States, 32751
Gastroenterology Group of Naples Not yet recruiting
Naples, Florida, United States, 34102
Internal Medicine Specialists Not yet recruiting
Orlando, Florida, United States, 32806
Citrus Ambulatory Surgery Center Not yet recruiting
Orlando, Florida, United States, 32806
Advanced Gastroenterology Center Not yet recruiting
Port Orange, Florida, United States, 32127
Endoscopy Center Not yet recruiting
Port Orange, Florida, United States, 32127
Port Orange Urgent Care Not yet recruiting
Port Orange, Florida, United States, 32127
Advanced Medical Research Center Not yet recruiting
Port Orange, Florida, United States, 32127
West Wind'r Research & Development, LLC Not yet recruiting
Tampa, Florida, United States, 33607
Shafran Gastroenterology Center Not yet recruiting
Winter Park, Florida, United States, 32789
Florida Medical Clinic Recruiting
Zephyrhills, Florida, United States, 33540
United States, Georgia
Georgia Endoscopy Center Recruiting
Alpharetta, Georgia, United States, 30005
Cardiovascular Specialist Not yet recruiting
Atlanta, Georgia, United States, 30342
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
Saint Joseph's Hospital of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30342
GI Consultants 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
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 Not yet recruiting
Topeka, Kansas, United States, 66606
United States, Maryland
Gastrointestinal Diagnostic Center Not yet recruiting
Baltimore, Maryland, United States, 21229
Digestive Disease Associates, PA Not yet 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 Not yet recruiting
Columbia, Maryland, United States, 21044
Shah Associates, MD, LLC Not yet recruiting
Prince Frederick, Maryland, United States, 20678
United States, Michigan
University of Michigan Health Systems - A. Alfred Taubman Health Care Center Not yet 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
United States, Minnesota
Mayo Clinic Not yet 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 Not yet 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 Recruiting
Vineland, New Jersey, United States, 08360
United States, New York
Long Island Clinical Research Associates, LLP Not yet recruiting
Great Neck, New York, United States, 11021
Nassau Gastroenterology Associates, PC Not yet recruiting
Great Neck, New York, United States, 11021
Nassau Gastroenterology Associates Not yet recruiting
Great Neck, New York, United States, 11021
United States, North Carolina
LeBauer Endoscopy Center Not yet recruiting
Greensboro, North Carolina, United States, 27403
LeBauer Research Associates, PA Not yet recruiting
Greensboro, North Carolina, United States, 27403
LeBauer HealthCare Not yet recruiting
Greensboro, North Carolina, United States, 27403
Carolina Research - Carolina Digestive Diseases Not yet recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Great Lakes Gastroenterology Recruiting
Mentor, Ohio, United States, 44060
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster, Ltd. Not yet recruiting
Lancaster, Pennsylvania, United States, 17604
Donald Guthrie Foundation for Education and Research Not yet recruiting
Sayre, Pennsylvania, United States, 18840
United States, Tennessee
Associates in Gastroenteroogy Not yet recruiting
Hermitage, Tennessee, United States, 37076
Associated Endoscopy Not yet recruiting
Hermitage, Tennessee, United States, 37076
Hermitage Imaging Not yet recruiting
Hermitage, Tennessee, United States, 37076
United States, Texas
Professional Quality Research, Inc. Not yet recruiting
Austin, Texas, United States, 78705
Austin Gastroenterology PA/Austin Endoscopy Center II Not yet recruiting
Austin, Texas, United States, 78745
Gastroenterology Consultants, P.A. Not yet recruiting
Houston, Texas, United States, 77034
Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center Not yet recruiting
Pasadena, Texas, United States, 77505
Digestive Health Specialists of Tyler Recruiting
Tyler, Texas, United States, 75701
United States, Utah
Wasatch Clinical Research Not yet recruiting
Salt Lake City, Utah, United States, 84107
Alpine Medical Group Not yet recruiting
Salt Lake City, Utah, United States, 84102
Wasatch Endoscopy Center Not yet recruiting
Salt Lake City, Utah, United States, 84124
United States, Wisconsin
Wisconsin Center for Advanced Research - GI Associates, LLC Recruiting
Milwaukee, Wisconsin, United States, 53215
Center for Digestive Health Recruiting
Milwaukee, Wisconsin, United States, 53215
Australia, Australian Capital Territory
ACT Health Directorate trading as The Cranberra Hospital Not yet recruiting
Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Concord Repatriation General Hospital Not yet recruiting
Concord, New South Wales, Australia, 2139
Liverpool Hospital Not yet recruiting
Liverpool, New South Wales, Australia, 2170
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Department of Gastroenterology, Box Hill Hospital Not yet 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 Not yet recruiting
Wien, Austria, A-1090
Belgium
GZA St. Vincentius Not yet recruiting
Antwerpen, Belgium, 2018
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Recruiting
Leuven, Belgium, 3000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Denmark
Aalborg Hospital Not yet recruiting
Aalborg, Denmark, 9000
Aarhus University Hospital/Medical Department V, Section of Gastroenterology Not yet recruiting
Aarhus, Denmark, 8000 C
Bispebjerg Hospital Not yet recruiting
Copenhagen NV, Denmark, DK2400
Odense University Hospital Not yet recruiting
Odense C, Denmark, 5000
Estonia
Ida-Viru Central Hospital Not yet recruiting
Kohtla-Jarve, Estonia, 30322
ECG Unit of East Viru Central Hospital Not yet recruiting
Kothla Jarve, Estonia, 30322
X-Ray Unit of East Viru Central Hospital Not yet recruiting
Kothla Jarve, Estonia, 30322
ECG Unit, Innomedica MCRC Not yet recruiting
Tallinn, Estonia, 10117
X-Ray Department of West Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10617
X-Ray department, Daugavpils Regional Hospital Not yet recruiting
Tallinn, Estonia, 10117
X-Ray Unit, East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10138
ECG Unit of West Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10617
ECG Unit East Tallinn Central Hospital Not yet recruiting
Tallinn, Estonia, 10138
Germany
Klinikum Luneburg Not yet recruiting
Bogelstrafe 1, Luneburg, Germany, 21339
Universitaetsklinikum Schleswig-Holstein, Campus Kiel Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Charite Campus Virchow-Klinikum Universitatsmedizin Berlin Not yet recruiting
Berlin, Germany, 13353
Klinikum der Wolfgang Goethe-Universitat, Medizinische Klinik 1, Haus 11, 3. Stock Not yet recruiting
Frankfurt, Germany, 60590
Medizinishce Hochschule hannover Not yet recruiting
Hannover, Germany, 30625
Universitatsklinikum Scheleswig-Holstein Not yet recruiting
Kiel, Germany, 24105
Klinikum Luneburg/Abteilung Gastroenterologie Not yet recruiting
Luneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden Not yet recruiting
Minden, Germany, 32423
Universitaetsklinikum Ulm Not yet recruiting
Ulm, Germany, 89081
Universitatsklinikum Ulm Not yet recruiting
Ulm, Germany, 89081
Japan
Fukuoka University Chikushi Hospital Recruiting
Chikushino, Fukuoka, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei general Hospital Not yet recruiting
Sapporo, Hokkaido, Japan
National Hospital Organization Sendai Medical Center Not yet recruiting
Sendai, Miyagi, Japan
Osaka Medical College Hospital Not yet recruiting
Takatsuki-shi, Osaka, Japan
Sapporo higashi tokushukai hospital Not yet recruiting
Hokkaido, Japan
Korea, Republic of
Pusan National University Hospital Not yet recruiting
Seo-Gu, Busan, Korea, Republic of, 602-739
Hanyang Univ. Guri Hospital Not yet recruiting
Gyunggi-do, Korea, Republic of, 471-701
Samsung Medical Center, Division of Gastroenterology, Department of Internal Medicine Not yet recruiting
Seoul, Korea, Republic of, 135-710
Kyung Hee University Hospital Not yet recruiting
Seoul, Korea, Republic of, 130-702
Seoul National University Hospital, Division of Gastroenterology, Department of Internal Medicine Not yet recruiting
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of, 120-752
Latvia
Endoscopy Department, Daugavpils Regional Hospital Not yet recruiting
Daugavpils, Latvia, LV-5417
X-Ray department, Daugavpils Regional Hospital Not yet recruiting
Daugavpils, Latvia, LV-5417
X-Ray Department, P.Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
ECG Unit, P.Stradins Clinical University Hospital Not yet recruiting
Riga, Latvia, LV-1002
X-Ray department, Clinic "Linezers", Riga East University Hospital Not yet recruiting
Riga, Latvia, LV-1006
New Zealand
Shakespeare Specialist Group Not yet recruiting
Milford, Auckland, New Zealand, 0620
Auckland District Health Board, Auckland City Hospital Not yet recruiting
Auckland, New Zealand, 1023
Christchurch Hospital Not yet recruiting
Christchurch, New Zealand, 8011
Southern District Health Board Not yet recruiting
Dunedin, New Zealand
Waikato Hospital Not yet recruiting
Hamilton, New Zealand, 3240
Clinical Trials Unit, BOP Clinical School, Bay of Plenty District Health Board Not yet recruiting
Tauranga, New Zealand, 3143
P3 Research Limited Not yet recruiting
Wellington, New Zealand, 2061
Slovakia
Nestatna Gastroenterologicka ambulancia Not yet recruiting
Bratislava, Slovakia, 851 01
Prevencia a zdravie s.r.o. Not yet recruiting
Bratislava, Slovakia, 85101
Gastroenterological Centre Thalion Not yet recruiting
Bratislava, Slovakia, 831 04
Univerzitna nemocnica Bratislava Not yet recruiting
Bratislava, Slovakia, 813 69
Jessenius - diagnosticke centrum a.s. Recruiting
Nitra, Slovakia, 949 01
KM Management spol. s.r.o. Recruiting
Nitra, Slovakia, 949 01
ProCare Medicinske centrum Nitra Not yet recruiting
Nitra, Slovakia, 949 01
Kardiocentrum Nitra s.r.o. Recruiting
Nitra, Slovakia, 949 01
NsP Nove Mesto nad Vahom n.o. Not yet recruiting
Nove Mesto nad Vahom, Slovakia, 915 01
South Africa
Medical Practice - Dr M Prins Not yet recruiting
Panorama, Cape Province, South Africa, 7500
Parklands Medical Centre Not yet recruiting
Durban, KZN/KwaZulu Natal, South Africa, 4091
Endocare Research Centre Not yet recruiting
Cape Town, Western Cape, South Africa, 7646
Louis Leipoldt Medical Centre Not yet recruiting
Cape Town, South Africa, 7530
Dr JP Wright Not yet recruiting
Claremont, Cape Town, South Africa, 7708
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
Study First Received: October 21, 2011
Last Updated: May 2, 2013
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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013