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RecruitingNot a traditional drug phaseobservationalRules rewrite

The Pathogenesis and Natural History of Sjogren's Disease

Background: -Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth.

Official registry: https://clinicaltrials.gov/study/NCT01425892 · National Institute of Dental and Craniofacial Research (NIDCR) · enrollment listed as 300

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 300 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

The Pathogenesis and Natural History of Sjogren's Disease

Primary outcome (registry wording): 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

Who it is for (from inclusion criteria)

  • Ages 16 Years to 100 Years
  • Fulfilling one the definitions below:
  • Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)
  • Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)
  • 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

Public study contact (from the registry)

Eileen M Pelayo

(301) 594-3097

eileen.pelayo@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT01425892 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT01425892?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT01425892?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary