A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 72 weeks of open-label treatment to evaluate the long-term safety of the drug.

Who is eligible to participate?

Inclusion Criteria: - Subjects between 18 and 66 years of age (Or 76 years of age if previously enrolled in study A7281008). - Subjects previously enrolled in study A7281009 (NCT01620255) or A7281008 (NCT01387594) who have completed the 84 day (12 week) induction period. Exclusion Criteria: - Subjects that have completed Day 84 (Week 12) of study A7281008 or 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).

Last updated:

8/12/2014

NCT ID:

NCT01771809

IRB Number:

12-010153