Back to resultsUse of Thalidomide in Chronic Uveitis
Primary Purpose
Uveitis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis focused on measuring Sarcoidosis, Chronic Uveitis, Uveitis, Thalidomide
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Sites / Locations
- University of Cincinnati Medical Center
Outcomes
Primary Outcome Measures
Need for corticosteroids to control eyes
Global assessment of ocular status
Secondary Outcome Measures
Toxicity
Full Information
NCT ID
NCT00314665
First Posted
April 12, 2006
Last Updated
December 3, 2007
Sponsor
University of Cincinnati
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00314665
Brief Title
Use of Thalidomide in Chronic Uveitis
Official Title
Use of Thalidomide in Chronic Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Cincinnati
Collaborators
Celgene Corporation
4. Oversight
5. Study Description
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, 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
Sarcoidosis, Chronic Uveitis, Uveitis, Thalidomide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
Need for corticosteroids to control eyes
Title
Global assessment of ocular status
Secondary Outcome Measure Information:
Title
Toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Baughman, MD
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0565
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Thalidomide in Chronic Uveitis
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