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The Pathogenesis and Natural History of Sjogren s Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
ClinicalTrials.gov Identifier:
NCT01425892
First received: August 27, 2011
Last updated: August 31, 2016
Last verified: April 2016
History of Changes
  Purpose

Background:

-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.

Objectives:

-To better understand how Sjogren s syndrome 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 syndrome or have at least two symptoms of Sjogren s syndrome.

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.

Condition
Pathogenesis
Sjogren's Syndrome
Salivary Gland

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Pathogenesis and Natural History of Sjogren s Syndrome

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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
Estimated Enrollment: 300
Study Start Date: July 2011
  Show Detailed Description

  Eligibility
Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

  • INCLUSION CRITERIA:

    1. Ability to sign informed consent form

    2. Fulfilling one the definitions below:

      1. Sj(SqrRoot)(Delta)gren s defined by European-American (EA) classification criteria for primary or secondary Sj(SqrRoot)(Delta)gren s syndrome (SS group)
      2. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SS group)
      3. Incomplete SS

      i. at least 2 of the EA criteria with a common manifestation of SS not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc)

      ii. 2 or more common manifestations of SS 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425892

Contacts
Contact: Lolita Bebris, R.N. (301) 594-1644 bebrisl@mail.nih.gov
Contact: Ilias G Alevizos, D.M.D. (301) 496-6207 alevizosi@mail.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Ilias G Alevizos, D.M.D. National Institute of Dental and Craniofacial Research (NIDCR)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT01425892     History of Changes
Other Study ID Numbers: 110172  11-D-0172 
Study First Received: August 27, 2011
Last Updated: August 31, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Salivary Gland
Pathogenesis
Sj(SqrRoot)(Delta)gren s Syndrome
Sjogren Syndrome

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
 Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 28, 2016