Protocol Number: 06-D-0181
Patients 18 years of age of age and older with Sjogren's syndrome may be eligible for this study. Candidates are screened with a history and physical examination, chest x-ray, and oral and 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 and placebo are injected under the skin once a week. During treatment and for 2 months after treatment, patients are evaluated as follows: Full comprehensive evaluations (at the beginning of the study, at week 13, at week 25 and 2 months after treatment ends): -Physical examination and blood draw. -Saliva collection. Saliva samples are collected 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 and sides of the tongue at 30-second intervals to stimulate saliva production. -Eye exam to evaluate tear gland function. -Questionnaires about mouth and eye dryness, energy level and overall well being. -Lip biopsy (at screening and week 13 visits only). A few minor salivary glands under the skin of the lower lip are removed for examination under a microscope. The lower lip is numbed, a small cut is made, and several tiny glands are removed. The cut is then closed with a few tiny stitches that are removed after 5 to 7 days. -Magnetic resonance imaging (MRI) 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 narrow metal cylinder containing a strong magnetic field). The head is held in place during the scan with a plastic strap and foam pads. The study lasts about 90 minutes. Short evaluations (at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends): -Medical history and 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.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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