The Pathogenesis and Natural History of Sjogren's Disease

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Study ID
NCT01425892
Status
Recruiting
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Conditions

  • Pathogenesis
  • Salivary Gland
  • Sjogren's Syndrome

Eligibility Criteria

Sex
ALL
Age
16 Years - 100 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 18, 2012
Status verified
Mar 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: incomplete sjogren's
    patients who meet criteria as incomplete sjogren's
  • Arm: primary sjogren's
    patients who meet criteria for classification for primary sjogren's
  • Arm: secondary sjogren's
    patients who meet classification criteria for secondary sjogren's

Primary Outcome Measure

Clinical phenotyping of SjD patients and controls over time Collection of samples for concurrent and future laboratory studies related to the pathogenesis Identification of biomarker candidates in SjD [ Time Frame: patients are followed up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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