The Pathogenesis and Natural History of Sjogren's Disease

NCT01425892 | Recruiting

• 2 other identifiers: 11017211-D-0172
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjogren's Syndrome; Salivary Gland; Pathogenesis

Keywords

Sjogren's Syndrome; Salivary Gland; Pathogenesis; Natural History; Sj(SqrRoot)(Delta)gren s syndrome; Sjogrens Syndrome

Outcome Measures

Primary Outcomes (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

  following the natural history of Sjogren's disease progression.

  patients are followed up to 10 years

Secondary Outcomes (1)

• 1. To establish a teaching cohort of patients with SjD or SjD-like conditions treated with conventional treatments 2. To identify patients for other protocols related to Sjogren's Disease

  Ongoing

Study Arms (3)

incomplete sjogren's

patients who meet criteria as incomplete sjogren's

primary sjogren's

patients who meet criteria for classification for primary sjogren's

secondary sjogren's

patients who meet classification criteria for secondary sjogren's

Eligibility Criteria

• Age: 16 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• 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

You may not qualify if:

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• Age \<16 years
• 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.

Sponsors & Collaborators

• National Institute of Dental and Craniofacial Research (NIDCR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (1)

• Burbelo PD, Ferre EMN, Chaturvedi A, Chiorini JA, Alevizos I, Lionakis MS, Warner BM. Profiling Autoantibodies against Salivary Proteins in Sicca Conditions. J Dent Res. 2019 Jul;98(7):772-778. doi: 10.1177/0022034519850564. Epub 2019 May 16.

  PMID: 31095438 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zohreh Khavandgar, D.D.S.

  National Institute of Dental and Craniofacial Research (NIDCR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen M Pelayo

CONTACT

(301) 594-3097; eileen.pelayo@nih.gov

Zohreh Khavandgar, D.D.S.

CONTACT

(301) 496-4486; zohreh.khavandgar@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2011
• First Posted: August 30, 2011
• Study Start: January 18, 2012
• Last Updated: April 20, 2026

Record last verified: 2026-03-17

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)