Use of Thalidomide in Chronic Uveitis

Sponsor

University of Cincinnati (Other)

Overall Status

Terminated

CT.gov ID

NCT00314665

Collaborator

Celgene Corporation (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis	Drug: Thalidomide	Phase 4

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.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Use of Thalidomide in Chronic Uveitis

Study Start Date :

Jan 1, 2004

Actual Study Completion Date :

Aug 1, 2006

Outcome Measures

Primary Outcome Measures

Need for corticosteroids to control eyes []
Global assessment of ocular status []

Secondary Outcome Measures

Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)