A Multicenter Open-Label Extension Study To Assess Long-Term Safety of PF-00547659 In Subjects With Crohn’s Disease
||David Hudesman, MD
frame of study:
||Mount Sinai Beth Israel
name, number and email
Duyang Kim at 212-844-6446 or firstname.lastname@example.org
This is an extension of the Pfizer OPERA A7281006 study where subjects know which therapy they are receiving. The primary objective of this study is to monitor the safety and tolerability of the study drug (PF-00547659) during long-term treatment. Subjects entering this study will be given a 75 mg dose at baseline and then every 4 weeks through Week 72. Subjects will then enter a 24-month follow-up period including 6 monthly visits followed by 18 month extended contact (every 6 month telephone contacts). At Week 96, subjects will undergo an End of Study visit but will continue the every 6 month telephone contacts until Week 168. Compensation will be provided and all research procedures, including drug, are covered by the sponsor.
- At least 18 years of age
- participated in Protocol A7281006 (IRB#029-13)
For additional information, or to participate, please contact Duyang Kim at 212-844-6446 or email@example.com.