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The Pathogenesis and Natural History of Sjogren's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Procedures mentioned: Physical exams, Questionnaires, Interviews, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Clinical data will be collected through questionnaires, personal interviews, physical examination, laboratory testing and imaging studies."
  • "The core evaluation will include a complete medical history and physical examination and a complete oral and dry eye evaluation."
  • "Blood, saliva and biopsy samples will be stored and used for laboratory research studies aimed at the pathogenesis of Sjogren s Disease."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how Sjogren’s disease starts and changes over time. This disease mainly affects glands that make tears and saliva, causing dry eyes and dry mouth. It is for people age 16 or older who have Sjogren’s disease or certain signs of it; it does not test a treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 16 or older.
  • You must be able to sign a form agreeing to join the study.
  • You must fit one of these groups: meet the study’s rules for Sjogren’s disease; meet those rules except for having another health condition; or have some signs of Sjogren’s disease as described below.
  • If you have only some signs, you must meet at least 2 of the study’s disease criteria plus have another common symptom, such as tiredness or swollen joints. Or, you must have at least 2 common symptoms outside those criteria that no other condition explains.

Who can't join

  • You are younger than 16.
  • You cannot or do not want to complete the required follow-up visits.
  • The study leader decides that a health condition, mental health condition, or treatment makes you unable to take part. This may include another cause for your symptoms.
  • You are an NIH employee who reports directly to the study leader, works as their co-worker, or is their relative.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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.

Study sites (1)

MD