The Pathogenesis and Natural History of Sjogren s Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01425892|
Recruitment Status : Recruiting
First Posted : August 30, 2011
Last Update Posted : September 12, 2019
-Sjogren 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 syndrome is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s syndrome.
-To better understand how Sjogren s syndrome begins and how it affects patients so that we can develop better ways to treat them.
- Participants must be 16 years of age or older.
- They must have a diagnosis of Sjogren s syndrome or have at least two symptoms of Sjogren s syndrome.
- 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.
|Condition or disease|
|Pathogenesis Sjogren's Syndrome Salivary Gland|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||The Pathogenesis and Natural History of Sjogren s Syndrome|
|Study Start Date :||August 27, 2011|
- Clinical phenotyping of SS patients and controls over time; Collection of samples for concurrent and future laboratory studies related to the pathogenesis; Identification of biomarker candidates in SS
- To establish a teaching cohort of patients with SS or SS-like conditions treated with conventional treatments; To identify patients for other protocols related to Sj(SqrRoot)(Delta)gren's Syndrome
- To identify patients for other protocols related to Sjogren's Syndrome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01425892
|Contact: Eileen M Pelayo||(301) firstname.lastname@example.org|
|Contact: Blake M Warner, D.D.S.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Blake M Warner, D.D.S.||National Institute of Dental and Craniofacial Research (NIDCR)|