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
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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 |
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 |


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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes 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.

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
United States, Maryland | |
National Institute of Dental And Craniofacial Research (NIDCR) | |
Bethesda, Maryland, United States, 20892 |
Publications:
ClinicalTrials.gov Identifier: | NCT00001599 History of Changes |
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:
Syndrome Sjogren's Syndrome Xerostomia 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 |