Sjögren's Syndrome Clinic
Current Clinical Studies
We are actively recruiting for
patients with Sjögrens syndrome. There are several ongoing clinical studies. If you
wish to obtain more information on a study, to participate as a subject or to refer
patients, please click on the study number below. Depending on the protocol, participants
can expect oral/dental, eye, general physical and rheumatological examinations, as well as
blood and other tests. Eye examinations will be conducted at the Eye Clinic at the
Clinical Center in collaboration with Dr. Janine Smith, an ophthalmologist who is
conducting clinical trials on inflammatory disorders of the eye, including Sjögrens
syndrome.
Clinical Investigation
84-D-0056
Evaluation and Treatment of Salivary Gland Dysfunction
In this protocol new patients are
screened for salivary dysfunction and to obtain as specific a diagnosis as possible for
their symptoms of dry mouth. This has also served as a natural history protocol and sera,
saliva, salivary gland biopsy material, and clinical data have been systematically
collected since January, 1983. The data and samples have been explored since that time to
investigate mechanisms and clinical manifestations of the disorder. Click on the protocol
number above for more information on this study. Currently, we are developing a new
protocol: "Natural History of Salivary Gland Dysfunction and Sjögrens
Syndrome" to investigate specific hypotheses regarding outcomes in the
Sjögrens syndrome Clinic cohort.
94-D-0018
Salivary Evaluation in Normal Volunteers
This protocol allows
us to recruit normal volunteers for the development of normative
data and as healthy control subjects for Sjögrens syndrome
studies.
00-D-0022
Functioning
of Immune and Hormonal Systems in Patients with Sjögren's Syndrome
and in Healthy Volunteers
This
study aims to learn more about how the immune and hormonal systems
function in patients with Sjögren's syndrome, a disease in which
the immune system does not function properly. Adult nonpregnant
females are invited to participate. Oral contraceptives may not
be taken for 6 weeks before and during this study, so another form
of birth control must be used, such as abstinence.
There
will be two visits. At the first visit, a medical history and physical
examination will be conducted, and blood and urine tests will be
done. The total amount of blood drawn will be 10 tablespoons. This
visit will last 3 hours. At the second visit, participants will
have an oral glucose tolerance test. To prepare for it, they must
be on a special diet for 3 days beforehand and keep a diary of eating,
sleeping, and physical activities for those 3 days. A urine sample
will be taken at the beginning of the visit. Subjects must then
drink a very sweet carbonated cola. A small plastic tube will be
placed into an arm vein. Blood will be drawn through this tube eight
times over 3 hours. The total amount of blood drawn will be 17 tablespoons.
Only
minor inconveniences are anticipated as a result of participating
in this study. Risks from blood tests include soreness, bruising,
and minor infection at the puncture site, and dizziness. The oral
glucose tolerance test may cause temporary stomach bloating, headache,
nausea, and vomiting.
Clinical trials
97-D-0123
Dehydroepiandrosterone (DHEA) Treatment for Sjögrens Syndrome
This is a 6 month pilot study of DHEA
versus placebo as treatment for Sjögrens syndrome. DHEA, a steroid hormone appears
to decrease autoimmune phenomena in other autoimmune diseases such as systemic lupus
erythematosus.
97-D-0133
Pilot Study of Thalidomide for Primary Sjögrens Syndrome
This is a 3 month study of thalidomide
versus placebo. Thalidomide is a drug that has been used to treat oral sores in AIDS
patients, to treat transplantation patients and to improve certain autoimmune diseases.
Thalidomide appears to diminish the effects of tumor necrosis factor alpha, a substance
that promotes inflammation and appears to have a role in inflammation at local tissue
sites in Sjögrens syndrome.
We are currently developing new protocols
for additional clinical trials.
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