The Pathogenesis and Natural History of Sjogren's Disease (NCT01425892) | Clinical Trial Compass
RecruitingNot Applicable
The Pathogenesis and Natural History of Sjogren's Disease
United States300 participantsStarted 2012-01-18
Plain-language summary
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.
Who can participate
Age range
16 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability to sign informed consent form
. 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)
. Incomplete SjD
Exclusion criteria
. Age \<16 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: patients are followed up to 10 years
Trial details
NCT IDNCT01425892
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
. inability or unwillingness to comply with follow up requirements
. 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)
. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.