Use of Thalidomide in Chronic Uveitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uveitis |
Drug: Thalidomide |
Phase 4 |
| Study Type: | Interventional |
| 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
- Toxicity
| Estimated Enrollment: | 15 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Ohio | |
| University of Cincinnati Medical Center | |
| Cincinnati, Ohio, United States, 45267-0565 | |
| Principal Investigator: | Robert P Baughman, MD | Professor of Medicine |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00314665 History of Changes |
| Other Study ID Numbers: | 03-08-28-05 |
| Study First Received: | April 12, 2006 |
| Last Updated: | December 3, 2007 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by University of Cincinnati:
|
Sarcoidosis Chronic Uveitis Uveitis Thalidomide |
Additional relevant MeSH terms:
|
Uveitis Chorioretinitis Uveal Diseases Eye Diseases Retinitis Retinal Diseases Choroiditis Choroid Diseases Uveitis, Posterior Panuveitis Thalidomide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013