Pilot Study of Thalidomide to Treat Sjogren's Syndrome

NCT00001599 | Completed Phase 2

• 2 other identifiers: 97013397-D-0133
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome; Xerostomia

Keywords

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

Interventions

Thalidomide DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institute of Dental And Craniofacial Research (NIDCR)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Shearn MA. Sjogren's syndrome. Med Clin North Am. 1977 Mar;61(2):271-82. doi: 10.1016/s0025-7125(16)31332-3. No abstract available.

  PMID: 577000 BACKGROUND

• Drosos AA, Andonopoulos AP, Costopoulos JS, Papadimitriou CS, Moutsopoulos HM. Prevalence of primary Sjogren's syndrome in an elderly population. Br J Rheumatol. 1988 Apr;27(2):123-7. doi: 10.1093/rheumatology/27.2.123.

  PMID: 3365531 BACKGROUND

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

  PMID: 4625796 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia; Autoimmune Diseases

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: May 1, 1997
• Study Completion: June 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-06

Locations

US (1)