Pilot Study of Thalidomide to Treat Sjogren's Syndrome
Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)