Scientists track Sjogren's disease to unlock its secrets
NCT ID NCT01425892
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 12 times
Summary
This study follows 300 people with Sjogren's disease (or symptoms) over time to learn how the condition starts and progresses. Participants undergo exams, saliva and tear tests, and questionnaires during several visits. No treatment is given; the goal is to gather data and samples to identify biomarkers and improve future care.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2012
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The population consists of patients who have completed our Sjogren's screening protocol (15-D-0051) and are deemed eligible to enroll in this pathogenesis protocol.
- Ages
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16 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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: <!-- --> 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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