Use of Thalidomide in Chronic Uveitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-08-31

Brief Summary

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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

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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.

Conditions

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Uveitis

Keywords

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Sarcoidosis Chronic Uveitis Uveitis Thalidomide

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thalidomide

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Robert P Baughman, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine

Locations

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University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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03-08-28-05

Identifier Type: -

Identifier Source: org_study_id