Understanding Sjogren's Disease and its Effects

The Pathogenesis and Natural History of Sjogren's Disease

This study is trying to learn more about Sjogren's Disease and how it affects people, by looking at their symptoms and health history.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 16 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT01425892 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 16 and older diagnosed with Sjogren's Disease or exhibiting at least two symptoms associated with the condition.

Not a fit: Patients under the age of 16 or those with conditions that prevent them from complying with follow-up requirements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and management strategies for patients with Sjogren's Disease.

How similar studies have performed: While the study focuses on understanding the disease's pathogenesis, similar observational studies have contributed valuable insights into autoimmune conditions, suggesting potential for meaningful findings.

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:

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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 this trial is running

Bethesda, Maryland

• 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

Conditions: Sjogren's Syndrome, Salivary Gland, Pathogenesis, Natural History, Sjgren s syndrome, Sjogrens Syndrome