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A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Ulcerative Colitis

Thank you

Trial Information

A Multi-Center, Open-Label Study Of CP-690,550 In Subjects With Moderate To Severe Ulcerative Colitis


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety measured by the number of reported adverse events

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3921139

NCT ID:

NCT01470612

Start Date:

October 2012

Completion Date:

December 2017

Related Keywords:

  • Ulcerative Colitis
  • Ulcerative colitis
  • open-label
  • long term treatment
  • Colitis
  • Colitis, Ulcerative
  • Ulcer

Name

Location

Cedars Sinai Medical CenterLos Angeles, California  90048-1804
Mayo ClinicRochester, Minnesota  55905
Cedars-Sinai Medical CenterLos Angeles, California  90048
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Cleveland ClinicCleveland, Ohio  44195
Atlanta Gastroenterology AssociatesAtlanta, Georgia  
Yale University School Of MedicineNew Haven, Connecticut  06520
Florida Medical ClinicZephyrhills, Florida  33542
UCSD Medical CenterLa Jolla, California  92093
University of California - San FranciscoSan Francisco, California  94143
Southern Clinical Research ConsultantsHollywood, Florida  33021
Aga Clinical Research Associates, LlcEgg Harbor Twp, New Jersey  08234
LeBauer Research Associates, PAGreensboro, North Carolina  27403
Internal Medicine SpecialistsOrlando, Florida  32806
Horizon Research Group, Inc.Mobile, Alabama  36608
Wasatch Clinical ResearchSalt Lake City, Utah  84107
Center for Advanced GastroenterologyMaitland, Florida  32751
West Wind'r Research & Development, LLCTampa, Florida  33607
Atlanta Center for Gastroenterology, P.C.Decatur, Georgia  30033
Center for Digestive HealthTroy, Michigan  48098
The Gastroenterology Group of South JerseyVineland, New Jersey  08360
Digestive Health Specialists of TylerTyler, Texas  75701
Regional Gastroenterology Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
Clinical Research Institute of Michigan, LLCChesterfield, Michigan  48047
Southwest GastroenterologyNew Lenox, Illinois  60451
Digestive Disease Associates, PABaltimore, Maryland  21229
Gastrointestinal Diagnostic CenterBaltimore, Maryland  21229
Howard County GIDCColumbia, Maryland  21044
Professional Quality Research, Inc.Austin, Texas  78705
Sharp Rees-Stealy Medical GroupSan Diego, California  92101
Desert Sun Clinical ResearchTucson, Arizona  85710
Gastroenterology Group of NaplesNaples, Florida  34102
Gastroenterology Associates of Central Georgia, LLCMacon, Georgia  31201
Great Lakes GastroenterologyMentor, Ohio  44060
Wisconsin Center for Advanced Research - GI Associates, LLCMilwaukee, Wisconsin  53215
Internal Medicine Center, LLCMobile, Alabama  36608
Springhill Memorial HospitalMobile, Alabama  36608
Adobe Clinical Research, LLCTucson, Arizona  85712
Desert Sun Surgery CenterTucson, Arizona  85710
Desert Sun GastroenterologyTucson, Arizona  85710
Adobe Surgery CenterTucson, Arizona  85712
Cedars-Sinai Medical Center - Inflammatory Bowel Disease CenterLos Angeles, California  90048
Southern California Research Institute Medical Group, Inc - West Gastroenterology Medical GroupLos Angeles, California  90045
West Gastroenterology Medical GroupLos Angeles, California  90813
Alliance Clinical ResearchOceanside, California  92056
Homan A Zadeh, MD, MPHPalm Springs, California  92262
Hope Square Surgical CenterRancho Mirage, California  92270
San Diego Endoscopy CenterSan Diego, California  92103
Endoscopy Center of Connecticut, LLCGuilford, Connecticut  06437
Gastroenterology Center of Connecticut, LLCHamden, Connecticut  06518
Medical Research Center of Connecticut, LLCHamden, Connecticut  06518
South Broway EndoscopyCooper City, Florida  33026
MNH Surgical CenterMaitland, Florida  32751
Citrus Ambulatory Surgery CenterOrlando, Florida  32806
Endoscopy CenterPort Orange, Florida  32127
Advanced Medical Research CenterPort Orange, Florida  32127
Advanced Gastroenterology CenterPort Orange, Florida  32127
Port Orange Urgent CarePort Orange, Florida  32127
Georgia Endoscopy CenterAlpharetta, Georgia  30005
Cardiovascular SpecialistAtlanta, Georgia  30342
Atlanta Gastroenterology Associates LLCAtlanta, Georgia  30342
Atlanta Gastroenterology Associates, LLC.Atlanta, Georgia  30342
GI ConsultantsAtlanta, Georgia  30342
Emory Healthcare Heart CenterJohns Creek, Georgia  30097
Cotton-O'Neil Clinical Research Center, Digestive HealthTopeka, Kansas  66606
Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical ResearchChevy Chase, Maryland  20815
University of Michigan Health Systems - A. Alfred Taubman Health Care CenterAnn Arbor, Michigan  48109-5000
Surgery Center of ColumbiaColumbia, Missouri  65201
Hannibal Regional HospitalHannibal, Missouri  63401
Audrian Medical CenterMexico, Missouri  65265
Center for Digestive & Liver Disease, Inc.Mexico, Missouri  65265
South Jersey GastroenterologyMarlton, New Jersey  08053
Long Island Clinical Research Associates, LLPGreat Neck, New York  11021
Nassau Gastroenterology Associates, PCGreat Neck, New York  11021
Nassau Gastroenterology AssociatesGreat Neck, New York  11021
LeBauer Endoscopy CenterGreensboro, North Carolina  27403
LeBauer HealthCareGreensboro, North Carolina  27403
Carolina Research - Carolina Digestive DiseasesGreenville, North Carolina  27834
Donald Guthrie Foundation for Education and ResearchSayre, Pennsylvania  18840
Associates in GastroenteroogyHermitage, Tennessee  37076
Hermitage ImagingHermitage, Tennessee  37076
Associated EndoscopyHermitage, Tennessee  37076
Austin Gastroenterology PA/Austin Endoscopy Center IIAustin, Texas  78745
Gastroenterology Consultants, P.A.Houston, Texas  77034
Pasadena Gastroenterology Associates, P.A. dba Digestive Health CenterPasadena, Texas  77505
Wasatch Endoscopy CenterSalt Lake City, Utah  84124
Alpine Medical GroupSalt Lake City, Utah  84102
Center for Digestive HealthMilwaukee, Wisconsin  53215