Use of Thalidomide in Chronic Uveitis
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, Methotrexate and or similar chemotherapy type drugs to control this inflammation. Despite these medications, patients still have inflammation in their eyes. Patients are being asked to add an additional drug, thalidomide.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Thalidomide in Chronic Uveitis|
- Need for corticosteroids to control eyes
- Global assessment of ocular status
|Study Start Date:||January 2004|
|Study Completion Date:||August 2006|
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 and effective in the treatment of patients with chronic inflammation in their eyes. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum leprosum (ENL). The drug works in many different ways, including as an anti-inflammation drug. Therefore, it is thought that this drug might be able to improve symptoms and lung function. At this time, the drug is not approved for use for uveitis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314665
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45267-0565|
|Principal Investigator:||Robert P Baughman, MD||Professor of Medicine|