Status:
COMPLETED
Pilot Study of Thalidomide to Treat Sjogren's Syndrome
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Sjogren's Syndrome
Xerostomia
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and effectiveness of thalidomide in treating Sjogren's syndrome. In this autoimmune disease, the immune system attacks the body's tear glands and salivary glands, c...
Detailed Description
Sjogren's syndrome (SS) is a systemic autoimmune disease that predominantly affects women. SS is characterized by lymphocytic infiltration of lacrimal and salivary glands leading to secretory function...
Eligibility Criteria
Primary Sjogren's Syndrome; symptoms of dry eyes and dry mouth; 6 week period off disease modifying agents, such as antimalarials or steroids.
No males.
No females with childbearing potential.
No patients with hypersensitivity to thalidomide.
No confounding medical illness or abnormal laboratory test that in the judgment of the investigators would pose added risk for study participants.
Key Trial Info
Start Date :
May 1 1997
Trial Type :
INTERVENTIONAL
End Date :
June 1 2002
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00001599
Start Date
May 1 1997
End Date
June 1 2002
Last Update
March 4 2008
Active Locations (1)
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1
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892