Pilot Study of Thalidomide to Treat Sjogren's Syndrome

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ClinicalTrials.gov Identifier: NCT00001599

Recruitment Status : Completed

First Posted : November 4, 1999

Last Update Posted : March 4, 2008

Sponsor:

Information provided by:

National Institutes of Health Clinical Center (CC)

Study Description

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, 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:

Patient assessment of dry mouth (rated on a scale from "worst ever" to "best ever"
Patient assessment of dry eyes (rated on a scale from "worst ever" to "best ever"
Patient health questionnaire and disease assessment rating
Saliva collection
Rose-Bengal or other dye tests for dryness - examination of the eyes under a bright light following administration of drops containing a dye
Schirmer's I test for dryness - placement of a thin rectangular strip of filter paper in the eye following administration of anesthetic drops
Blood tests to measure blood cell counts and levels of various immune substances in the blood, and to evaluate liver and kidney function
Urine tests to evaluate kidney function
Nerve conduction tests - measurement of the speed with which nerves conduct electrical impulses. Two nerves in the arm and one nerve in the leg will be tested.

Participants will also be contacted by telephone every week to report any side effects.

Condition or disease	Intervention/treatment	Phase
Sjogren's Syndrome Xerostomia	Drug: Thalidomide	Phase 2

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 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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	28 participants
Primary Purpose:	Treatment
Official Title:	Pilot Study of Thalidomide for Sjogren's Syndrome
Study Start Date :	May 1997
Study Completion Date :	June 2002

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sjögren syndrome

MedlinePlus related topics: Dry Mouth Sjogren's Syndrome

Drug Information available for: Thalidomide

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

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): NCT00001599

Locations

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United States, Maryland
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

More Information

Publications:

Shearn MA. Sjögren's syndrome. Med Clin North Am. 1977 Mar;61(2):271-82.

Drosos AA, Andonopoulos AP, Costopoulos JS, Papadimitriou CS, Moutsopoulos HM. Prevalence of primary Sjögren's syndrome in an elderly population. Br J Rheumatol. 1988 Apr;27(2):123-7.

Anderson LG, Talal N. The spectrum of benign to malignant lymphoproliferation in Sjögren's syndrome. Clin Exp Immunol. 1972 Feb;10(2):199-221.

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ClinicalTrials.gov Identifier:	NCT00001599
Other Study ID Numbers:	970133 97-D-0133
First Posted:	November 4, 1999 Key Record Dates
Last Update Posted:	March 4, 2008
Last Verified:	June 2002

Keywords provided by National Institutes of Health Clinical Center (CC):


Xerostomia Autoimmunity Salivary Glands Lacrimal Function	Immunomodulator Sjogren's Syndrome Dry Mouth

Additional relevant MeSH terms:

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Sjogren's Syndrome Xerostomia Syndrome Disease Pathologic Processes Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases	Eye Diseases Connective Tissue Diseases Autoimmune Diseases Immune System 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

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