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The Pathogenesis and Natural History of Sjogren's Disease

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 343 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fields
  2. Minor Re-verified, no change to tracked fields
  3. Minor Re-verified, no change to tracked fields
  4. Minor Re-verified, no change to tracked fields
  5. Minor Re-verified, no change to tracked fields
Show 45 earlier versionsHide 45 earlier versions
  1. Minor New version filed on ClinicalTrials.gov
  2. Minor 39 versions Re-verified since Apr 22, 2025, no change to tracked fieldsv299-v337
  3. Minor Enrollment target: 400 to 300v298
  4. Minor 4 versions Re-verified since Mar 13, 2025, no change to tracked fieldsv294-v297
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01425892
Lead Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Conditions
(from sponsor)
Sjogren's Syndrome, Salivary Gland, Pathogenesis
Related terms Sjogren's Syndrome
Enrollment 300 participants
Start Date
Updated on ClinicalTrials.gov