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

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT01470612

Run by

Pfizer

People needed

944

Starts

2012-10-01

Expected to finish

2020-08-06

Last updated by the study team

2021-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Desert Sun Clinical Research, LLC — Tucson, Arizona, United States
• Desert Sun Gastroenterology — Tucson, Arizona, United States
• Desert Sun Surgery Center — Tucson, Arizona, United States
• Altman Clinical and Translational Research Institute — La Jolla, California, United States
• Perlman Medical Offices - UC San Diego Health System — La Jolla, California, United States
• UCSD Medical Center — La Jolla, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Cedars Sinai Surgery Center — Los Angeles, California, United States
• Alliance Clinical Research — Oceanside, California, United States
• Center for Endoscopy- Covenant Surgical Partners — Oceanside, California, United States
• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Clinical Applications Laboratories, Inc — San Diego, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• UCSF Center for Colitis and Crohn's Disease — San Francisco, California, United States
• Connecticut Clinical Research Institute — Bristol, Connecticut, United States
• Endoscopy Center of Connecticut, LLC — Guilford, Connecticut, United States
• Endoscopy Center of Connecticut, LLC — Hamden, Connecticut, United States
• Gastroenterology Center of Connecticut, PC — Hamden, Connecticut, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• North Florida Gastroenterology Research, LLC — Orange Park, Florida, United States
• Citrus Ambulatory Surgery Center — Orlando, Florida, United States
• Alabama Medical Group, P.C. — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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