Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001599
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Pilot Study of Thalidomide to Treat Sjogrens Syndrome
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Thalidomide for Sjogrens Syndrome
Status:
COMPLETED
Status Verified Date:
2002-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and effectiveness of thalidomide in treating Sjogrens syndrome In this autoimmune disease the immune system attacks the bodys 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 Sjogrens 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 Sjogrens 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
Schirmers 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
Women with Sjogrens 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 Sjogrens 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
Schirmers 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
Detailed Description:
Sjogrens 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 Sjogrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-D-0133 | None | None | None |