Long-Term Safety Of PF-00547659 In Ulcerative Colitis

Completed · Phase 2

Conditions studied: Ulcerative Colitis

In brief

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

Key facts

Study ID

NCT01771809

Run by

Shire

People needed

330

Starts

2013-03-18

Expected to finish

2017-12-13

Last updated by the study team

2021-06-03

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects between 18 and 66 years of age.
• Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.

You may not qualify if…

• Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
• Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).

Where it is running

• UCSD Altman Clinical and Translational Research Institute — La Jolla, California, United States
• Community Clinical Trials — Orange, California, United States
• Rocky Mountain Gastroenterology — Thornton, Colorado, United States
• Medical Research Center of Connecticut, LLC — Hamden, Connecticut, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Bassan and Bloom M.D.s — Miramar, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Commonwealth Clinical Studies — Brockton, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Minnesota Gastroenterology, PA — Plymouth, Minnesota, United States
• Center for Digestive and Liver Diseases — Mexico, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nevada School of Medicine — Las Vegas, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Albany Medical College — Albany, New York, United States
• Weill Cornell Medical College of Cornell University — New York, New York, United States
• Premier Medical Group of the Hudson Valley, PC — Poughkeepsie, New York, United States
• UNC Memorial Hospital — Chapel Hill, North Carolina, United States
• The Oregon Clinic-West Hills Gastroenterology Associates, P.C. — Portland, Oregon, United States
• Gastro One — Germantown, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Mayo Clinic Arizona - Scottsdale — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.