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Sponsored by: |
National Institute of Dental and Craniofacial Research (NIDCR) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00001599 |
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, causing dry mouth and dry eyes. Thalidomide has shown promise in treating other autoimmune disorders, such as rheumatoid arthritis and systemic lupus erythematosus.
Women with Sjogren's syndrome who have dry eyes and dry mouth may be eligible for this study. Women of childbearing potential will not be considered for participation because of severe birth defects associated with thalidomide. Also, since Sjogren's syndrome affects many fewer men than women, men are excluded from this pilot study because they would be too few in number to assess as a separate group. Candidates will be screened with a medical history, physical examination, blood and urine tests, electrocardiogram, chest X-ray and pregnancy test. Tests will also be done to measure the conduction of electrical impulses along the nerves and to evaluate dryness of the eyes.
Participants will be randomly assigned to take either thalidomide or a placebo (look-alike pill with no active ingredient). The thalidomide dosage will be increased gradually from a starting dose of 50 Mg. up to 300 Mg., depending on side effects. Women of childbearing age who have had a tubal ligation or longstanding infertility will have a pregnancy test every 2 or 4 weeks.
Participants will come to the clinic at the first study visit and again at weeks 4, 8 and 12 for some or all of the following procedures:
Participants will also be contacted by telephone every week to report any side effects.
Condition | Intervention | Phase |
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Sjogren's Syndrome Xerostomia |
Drug: Thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Official Title: | Pilot Study of Thalidomide for Sjogren's Syndrome |
Estimated Enrollment: | 28 |
Study Start Date: | May 1997 |
Estimated Study Completion Date: | June 2002 |
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 loss, and the symptoms of dry eyes and dry mouth. After bone marrow transplantation, most patients with chronic graft versus host disease (GVHD) develop symptoms of oral dryness and salivary gland lymphocytic infiltrates indistinguishable from SS. Thalidomide has not been studied as a treatment for Sjogren's syndrome, but pilot studies suggest that it may be beneficial in the treatment of a number of autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, and various skin disorders, as well as in the treatment of chronic graft versus host disease. Major adverse effects of thalidomide include teratogenicity, neuropathy and sedation. The study is a 12 week randomized, double-blinded, pilot clinical trial designed to screen for potential efficacy and to evaluate the safety and potential adverse effects of 300 mg thalidomide daily compared with placebo in 28 patients with primary SS (PSS).
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
Study ID Numbers: | 970133, 97-D-0133 |
Study First Received: | November 3, 1999 |
Last Updated: | March 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00001599 |
Health Authority: | United States: Federal Government |
Xerostomia Autoimmunity Salivary Glands Lacrimal Function |
Immunomodulator Sjogren's Syndrome Dry Mouth |
Mouth Diseases Autoimmune Diseases Thalidomide Joint Diseases Eye Diseases Arthritis, Rheumatoid Lacrimal Apparatus Diseases Dry Eye Syndromes |
Rheumatic Diseases Xerostomia Musculoskeletal Diseases Arthritis Connective Tissue Diseases Sjogren's Syndrome Stomatognathic Diseases Salivary Gland Diseases |
Anti-Infective Agents Disease Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors |
Pharmacologic Actions Anti-Bacterial Agents Pathologic Processes Syndrome Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Leprostatic Agents |