This study will test the effectiveness of etanercept (Enbrel) for treating Sjogren's
syndrome-an autoimmune disease that affects the secreting glands. (In autoimmune diseases,
the immune system attacks the body's own tissues.) Reduced lacrimal (tear) gland function
causes dry eyes with a scratchy sensation, and, in severe cases, vision be may impaired.
Reduced salivary gland function causes dry mouth, resulting in greatly increased tooth decay.
Dry mouth also makes chewing and swallowing difficult, which may lead to nutrition
deficiencies. Sjogren's syndrome can also cause dryness of the skin and of mucous membranes
in the nose, throat, airways, and vagina.
Patients with Sjogren's syndrome who have had oral and eye examinations under NIDCR's
protocol 84-D-0056 may participate in this study. Participants will be randomly assigned to
receive either etanercept or placebo (an inactive look-alike substance) by injection under
the skin twice a week for 3 months.
Patients will be seen for evaluation before treatment begins (baseline) and again at 1, 3,
and 4 months. The baseline and 3-month visits include a physical examination, eye
examination, saliva collection from salivary glands, blood tests, and evaluation for changes
in symptoms and treatment side effects. The 1- and 4-month visits include saliva collection,
blood tests, and review of symptoms and treatment side effects. In addition, blood will be
drawn every 2 weeks for safety monitoring. Patients will also be surveyed weekly (by
telephone or during the clinic visit) about symptoms and treatment side effects.
The Food and Drug Administration has approved Enbrel for treating certain forms of arthritis,
which, like Sjogren's syndrome, are autoimmune disorders of the connective tissue. Laboratory
studies also indicate that etanercept may be an effective treatment for Sjogren's syndrome.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)