Pilot Study of Thalidomide to Treat Sjogren's Syndrome

March 3, 2008 updated by: National Institute of Dental and Craniofacial Research (NIDCR)

Pilot Study of Thalidomide for Sjogren's Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1997

Study Completion

June 1, 2002

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

November 3, 1999

First Posted (ESTIMATE)

November 4, 1999

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

June 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970133
  • 97-D-0133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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