A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis (A3921139)
ID Number 13-0624Principal Investigator(s)
James F Marion
Department(s) or Division(s)
The purpose of this research study is to assess the safety and tolerability of long-term tofacitinib therapy in patients with Ulcerative Colitis (UC). A3921139 is an open label study, which means that tofacitinib (also known as tofacitinib citrate or CP-690,550) is given to all patients in the trial. To be suitable to enter A3921139, one must have already completed previous trial(s) with tofacitinib.
Subjects are being asked to take part in this research study because they have moderate to severe ulcerative colitis.
Tofacitinib is a new investigational drug. A new investigational drug is one that is currently not approved for sale in this country. Because this is a research study, tofacitinib will be given to subjects only during this study and not after the study is over.
Funds for conducting this research are provided by Pfizer, Inc, manufacturer of the study drug.
Subject participation in this research study is expected to last for about 36 months. Subjects will need to visit the research site at least 15 times during the study. However, this study will continue until whichever comes first, Month 36 or the 1st market approval of tofacitinib for UC in a global major market, and therefore subjects may be in this study for less than or longer than 36 months.
The number of people expected to take part in this research study at this site is 10.
The total number of people expected to take part in this research study is 725. The study is being done at about 280 different research sites in 30 countries.
This is an open label study and all patients will receive either 5 mg or 10 mg tofacitinib twice a day, depending on the status of their UC at the baseline visit.
Recruiting Patients: Yes