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New Clinical Trials for Crohn's Disease and Ulcerative Colitis.

April 30, 2013
by Annie Coe

Tofacitinib for UC – enrollment expected to begin within the next month

Tofacitinib is an oral drug that works by blocking a group of enzymes that act like a gate into the cells of the immune system. By blocking these enzymes, the cells of the immune system are expected to produce fewer chemicals believed to cause bowel inflammation in UC.

There are 3 associated trials.

Induction study:  This study lasts 9 weeks where participants are randomly assigned to receive the study drug at a dose of 10mg twice daily, or placebo twice daily. The chance of receiving study drug in this study is 80%. Participants who respond to study product in the induction study will be eligible to enter a 52 week maintenance study.

52 week maintenance study:  In this study, participants are re-assigned to either receive study drug at a dose of 10mg twice daily, 5mg twice daily, or placebo twice daily. The chance of receiving study drug in this study is 67%. For those participants who fail to respond after the induction study or who lose response in the maintenance study, and for those who complete the maintenance study, there is an open label study.

Open label study:  participants will receive the study drug at a dose of 10mg twice daily or 5mg twice daily. This open label study will continue until the study sponsor receives approval for the study drug for the UC indication.

Please note that the induction and maintenance studies are double blind, so neither you nor your study doctor will know which treatment group you are in. The studies have specific requirements and procedures and you can contact Annie at  Carolann.coe@yale.edu for more info.

 

GSK for Crohn’s Disease – enrollment to begin in the next several months

The study drug in this trial is an oral pill that works by preventing the migration of inflammatory cells to the digestive tract.

It has 3 associated studies.

First study: This study lasts 12 weeks. Participants will receive the study drug either at a dose of 500mg once daily or 500mg twice daily. For those who respond, there is a 52 week maintenance trial.

52 week maintenance trail:  participants are assigned to either receive the study drug at a dose of 500mg once daily, 500mg twice daily, or placebo. The chance of receiving study drug in this study is 67%. Participants who complete the maintenance study can enter an open label study which lasts for 108 weeks.

108 weeks study:  In this study, participants will receive the study drug at a dose of 500mg twice daily.

Please note that the first two studies  are double blind, so neither you nor  your study  doctor will know which treatment group you are in. The studies have specific requirements and procedures and you can contact Annie  at Carolann.coe@yale.edu for more info.

Submitted by Fernanda Ave on April 30, 2013