Actively Recruiting

Age: 16Years - 100Years
All Genders
NCT01425892

The Pathogenesis and Natural History of Sjogren's Disease

Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-04-20

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Pathogenesis and Natural History of Sjogren's Disease

Who Can Participate

Age: 16Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to sign informed consent form
  • Diagnosis of Sjogren's Disease defined by European-American classification criteria for primary or secondary Sjogren's Disease
  • Participants excluded from the European-American criteria due to a comorbid condition but otherwise meeting these criteria
  • Incomplete Sjogren's Disease with at least two criteria or common manifestations such as fatigue, vasculitis, arthritis, or autonomic dysfunction not explained by other conditions
  • Participants aged 16 years or older
Not Eligible

You will not qualify if you...

  • Age under 16 years
  • Inability or unwillingness to comply with follow-up requirements
  • Any medical or psychological condition or treatment that would exclude the subject from research, as judged by the Principal Investigator
  • NIH employees who report directly to or are relatives or coworkers of the Principal Investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

E

Eileen M Pelayo

CONTACT

Z

Zohreh Khavandgar, D.D.S.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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