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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
Open (Enrolling)
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

Type of Study:


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:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2012

Completion Date:

December 2017

Related Keywords:

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



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Cedars-Sinai Medical Center Los Angeles, California  90048
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Cleveland Clinic Cleveland, Ohio  44195
Atlanta Gastroenterology Associates Atlanta, Georgia  
Yale University School Of Medicine New Haven, Connecticut  06520
Florida Medical Clinic Zephyrhills, Florida  33542
UCSD Medical Center La Jolla, California  92093
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