NCT01425892 The Pathogenesis and Natural History of Sjogren's Disease
| NCT ID | NCT01425892 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Dental and Craniofacial Research (NIDCR) |
| Condition | Sjogren's Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2012-01-18 |
| Primary Completion | — |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Background: -Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s Disease. Objectives: -To better understand how Sjogren s Disease begins and how it affects patients so that we can develop better ways to treat them. Eligibility: * Participants must be 16 years of age or older. * They must have a diagnosis of Sjogren s Disease or have at least two symptoms of Sjogren s Disease. Design: * People taking part in the study will come to the NIH Clinical Center for at least three visits. * During these visits, participants will have a medical history and physical exam. They will have oral and dental assessments, and saliva collection. Lab tests (blood and urine) and dry eye exams will be done. Participants will answer questionnaires and have salivary scintigraphy (adults only unless required for diagnosis). * Other optional tests may also be done. Participants may have to come in for additional visits if they have these optional tests or if their disease changes. * The only treatment provided as part of this study is for medical emergencies or complications that occur while you are at NIH for evaluation.
Eligibility Criteria
* INCLUSION CRITERIA: 1. Ability to sign informed consent form 2. Fulfilling one the definitions below: 1. Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group) 2. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group) 3. Incomplete SjD i. at least 2 of the EA criteria with a common manifestation of SjD not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc) or ii. 2 or more common manifestations of SjD which are not included in the EA criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions EXCLUSION CRITERIA: <!-- --> 1. Age \<16 years 2. inability or unwillingness to comply with follow up requirements 3. Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude th