Clinical Studies

Breast Care
Cardiology
Colon Cancer
Dermatology
Diabetes
Gastrointestinal
HIV/AIDS
Mental Health
Neurology
NeuroOphthalmology
Obesity/Weight Management
Women's Health
Other


Special Features
Advances/Research

 

A Multicenter Open-Label Extension Study To Assess Long-Term Safety of PF-00547659 In Subjects With Crohn’s Disease

Principal Investigator:   David Hudesman, MD
Time frame of study:   Ongoing
Location of Study:   Mount Sinai Beth Israel
Contact name, number and email  

Duyang Kim at 212-844-6446 or dukim@chpnet.org


Summary:
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.


Eligibility Participants:

  • 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 dukim@chpnet.org.