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Use of Thalidomide in Chronic Uveitis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314665
First Posted: April 14, 2006
Last Update Posted: December 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Celgene Corporation
Information provided by:
University of Cincinnati
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Thalidomide in Chronic Uveitis

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Need for corticosteroids to control eyes
  • Global assessment of ocular status

Secondary Outcome Measures:
  • Toxicity

Estimated Enrollment: 15
Study Start Date: January 2004
Study Completion Date: August 2006
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00314665


Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0565
Sponsors and Collaborators
University of Cincinnati
Celgene Corporation
Investigators
Principal Investigator: Robert P Baughman, MD Professor of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00314665     History of Changes
Other Study ID Numbers: 03-08-28-05
First Submitted: April 12, 2006
First Posted: April 14, 2006
Last Update Posted: December 6, 2007
Last Verified: December 2007

Keywords provided by University of Cincinnati:
Sarcoidosis
Chronic Uveitis
Uveitis
Thalidomide

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents