View clinical trials related to Sjogren's Syndrome.
Filter by:This research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. We hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function. People with or without dry eye syndrome may enroll.
The purpose of the study is to find out if the experimental study agent, baminercept, is effective in treating patients with Sjögren's syndrome. The study will also determine if the study agent can be safely given to patients with Sjögren's syndrome; examine how it affects symptoms of the disease; and attempt to understand how baminercept affects the underlying mechanisms of Sjögren's syndrome and the immune system.
Background: Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with Sjögren's syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works. Objectives: - To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome. Eligibility: - Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation. Design: - Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms. - At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood. - Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms. - Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before. - Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.
This study will examine the effect of the drug Raptiva (efalizumab) in patients with Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva & tears. The cause of SS is not known, but inflammation plays an important role. Raptiva is approved by the Food and Drug Administration to treat psoriasis, an inflammatory skin disease. Patients 18 years of age & older with SS may be eligible for this study. Candidates are screened with a history & physical examination, chest x-ray, and oral & eye examinations. Participants are randomly assigned to receive either Raptiva or placebo (an inactive substance that looks like Raptiva) for the first 3 months of the study. For the next 3 months, all participants receive Raptiva. Both Raptiva & placebo are injected under the skin once a week. Evaluation during treatment & for 2 months after treatment as follows: Full comprehensive evaluations (beginning of the study, at weeks 13 & 25 and 2 months after treatment ends): - Physical examination & blood draw. - Saliva collection done in two ways: 1) suctions cups connected to collection tubes are placed over the salivary gland ducts in the mouth and under the tongue; and 2) a sour-tasting liquid is applied to the top & sides of the tongue at 30-second intervals to stimulate saliva production. - Eye exam for tear gland function. - Questionnaires about mouth & eye dryness, energy level and overall well-being. - Lip biopsy (screening & week 13 visits only). A few minor salivary glands are removed for examination under a microscope. The lower lip is numbed, a small cut is made on the inside of the lip, and several glands are removed. The cut is closed with a few stitches that are removed after 5 to 7 days. - Magnetic resonance imaging of the parotid glands (salivary glands near the ear) at weeks 1, 13 and 25. The patient lies on a stretcher that is moved into the scanner (a metal cylinder containing a strong magnetic field). The head is held in place during the scan. The study lasts about 90 minutes. - Short evaluations at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends. - Medical history & physical examination, blood draw, evaluation for changes in symptoms and side effects, review of current medications at weeks 3, 9, 15 and 21. - Laboratory tests, evaluation for changes in symptoms and side effects, review of current medications, saliva collection without the sour liquid and short evaluation of tear production at weeks 5 and 17. - Blood tests at week 29
This study will evaluate patients with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary gland secretions have antibacterial, lubricatory, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning, or ulcerated oral mucosal; problems chewing, swallowing, and speaking; and diminished taste and smell. Patients with dry mouth complaints suggestive of salivary gland dysfunction may be eligible for this study. In addition, patients with recent onset of arthritis may enroll. Patients with arthritis are at risk for developing a disorder called Sjogren's syndrome, in which the glands that produce saliva may be damaged. Participants will have a complete medical and dental history. Saliva samples will be collected from the major salivary glands, which are located in the cheeks and under the jaw. Several blood samples will also be drawn for tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sjogren's syndrome and determine the extent of changes in the salivary glands. The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function.