Status:
TERMINATED
Use of Thalidomide in Chronic Uveitis
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Celgene Corporation
Conditions:
Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This research study is for patients that have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. Patients are currently being treated with Remicade, Humira, Methotrexa...
Detailed Description
Patients will be in the study for approximately 24 weeks. The visits are at screening, baseline (week 0), and weeks 4,8,12, and 24. The purpose of this research study is to see if Thalidomide is safe...
Eligibility Criteria
Inclusion
- You are being asked to take part in this research study because you have been diagnosed with chronic uveitis, a disease that causes inflammation in the eye. You are currently being treated with Remicade, Humira, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, you still have inflammation in your eyes. You are being asked to add an additional drug, thalidomide.
Exclusion
- You will not participate in this research study if any of the following apply to you:
- Pregnant
- If you are a man or woman not willing to take adequate birth control measures comply with FDA-mandated S.T.E.P.S.â program. .
- If you are a breast feeding woman
- If you have a significant peripheral neuropathy (numbness or tingling in your hands or feet)
- Have had a recent blood clot in your leg or lungs
- If you are currently receiving biphosphonates such as zoledronic acid (fosamax)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00314665
Start Date
January 1 2004
End Date
August 1 2006
Last Update
December 6 2007
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0565