Understanding Sjogren's Disease and its Effects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the pathogenesis and natural history of Sjogren's Disease, an autoimmune condition that primarily affects the salivary and lacrimal glands, leading to symptoms like dry mouth and dry eyes. Participants aged 16 and older, who have a diagnosis of Sjogren's Disease or exhibit at least two related symptoms, will undergo a series of assessments at the NIH Clinical Center. These assessments include medical history, physical exams, oral and dental evaluations, and saliva collection to gather comprehensive data on the disease's progression and impact. The ultimate goal is to enhance understanding of the disease to inform better treatment strategies.

Why it matters

Who can join: the full rules

* 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:

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  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 the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)
  4. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Zohreh Khavandgar, D.D.S. — National Institute of Dental and Craniofacial Research (NIDCR)
• Study coordinator: Eileen M Pelayo
• Email: eileen.pelayo@nih.gov
• Phone: (301) 594-3097

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.