Use of Thalidomide in Chronic Uveitis - Full Text View

Sponsors and Collaborators:	University of Cincinnati Celgene Corporation
Information provided by:	University of Cincinnati
ClinicalTrials.gov Identifier:	NCT00314665

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 IV

Drug Information available for: Thalidomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Use of Thalidomide in Chronic Uveitis

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	03-08-28-05
Study First Received:	April 12, 2006
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00314665
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Keywords provided by University of Cincinnati:

Sarcoidosis
Chronic Uveitis
Uveitis
Thalidomide

Study placed in the following topic categories:

Thalidomide
Uveitis
Eye Diseases
Sarcoidosis

Additional relevant MeSH terms:

Anti-Infective Agents
Uveal Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009