Status:
RECRUITING
The Pathogenesis and Natural History of Sjogren's Disease
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Sjogren's Syndrome
Salivary Gland
Eligibility:
All Genders
16-100 years
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 th...
Detailed Description
Background Sjogren's Disease (SjD; formely Sjogren's Syndrome) is an autoimmune disease characterized by chronic inflammation involving the exocrine glands. Salivary and lacrimal glands are predomina...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Ability to sign informed consent form
- Fulfilling one the definitions below:
- Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)
- Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)
- 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:
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- Age \<16 years
- inability or unwillingness to comply with follow up requirements
- Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)
- NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.
Exclusion
Key Trial Info
Start Date :
January 18 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01425892
Start Date
January 18 2012
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892