Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT01425892 |
Other study ID # |
110172 |
Secondary ID |
11-D-0172 |
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 18, 2012 |
Study information
Verified date |
June 14, 2024 |
Source |
National Institutes of Health Clinical Center (CC) |
Contact |
Eileen M Pelayo |
Phone |
(301) 594-3097 |
Email |
eileen.pelayo[@]nih.gov |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Background:
-Sjogren s Disease 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.
Description:
Background
Sj(SqrRoot)(Delta)gren s Disease (SjD; formely Sj(SqrRoot)(Delta)gren s Syndrome) is an
autoimmune disease characterized by chronic inflammation involving the exocrine glands.
Salivary and lacrimal glands are predominantly affected leading to dry mouth and dry eyes but
other exocrine organs are also frequently involved. It is one of the most common rheumatic
autoimmune diseases, which effects between 1-4 million Americans, predominantly women with a
female to male ratio of 9:1. Sj(SqrRoot)(Delta)gren s Disease may occur alone (primary SjD),
or may coexist with other systemic connective tissue disorders (i.e., secondary SjD). In many
cases systemic manifestations, such as fatigue, arthritis, vasculitis, lung disease,
peripheral or central neuropathy and autonomic nervous system dysfunction accompany glandular
involvement. Patients with systemic manifestations are at higher risk of lymphoma, the
incidence of which is increased in SjD. The treatment of sicca symptoms is mainly
symptomatic, whereas management of extraglandular manifestations is similar to other
autoimmune diseases.
The cause and pathogenesis of Sj(SqrRoot)(Delta)gren s Disease is still largely unknown. In a
genetically predisposed individual various environmental factors, such as viral infections,
may lead to epithelial cell activation and a protracted inflammatory response with features
of autoimmunity. Autoreactive lymphocytes and autoantibodies are considered important in this
process although the pathogenic role of any particular autoantibody is still undefined.
Although inflammation may contribute to the exocrinopathy of SjD, the relationship between
inflammation and exocrine dysfunction is poorly understood. Moreover, the model does not
explain many of the extraglandular manifestations of SjD patients, such as fatigue. Further
studies are needed to better understand the pathogenesis of SjD.
Objectives
The primary objective of this study is to enable the collection of longitudinal clinical and
laboratory data and biologic specimens to identify pathogenetic mechanisms of SjD by careful
clinical phenotyping of SjD patients and Sj(SqrRoot)(Delta)gren s-like conditions over time
and collection of biologic samples for concurrent and future laboratory studies related to
the pathogenesis of Sj(SqrRoot)(Delta)gren s Disease. Another objective of the study is to
identify biomarker candidates associated with the diagnosis, severity, prognosis, or organ
involvement in SjD. The protocol will enable the study of the genetic basis and the
mechanistic aspects of immunologic and non-immunologic abnormalities of SjD and their
associations with various clinical phenotypes.
Eligibility Criteria
The study will enroll 300 subjects with Sj(SqrRoot)(Delta)gren s Disease or
Sj(SqrRoot)(Delta)gren s-like conditions. Subjects aged 16-years or older fulfilling European
American Consensus Criteria for Primary or Secondary Sj(SqrRoot)(Delta)gren s Disease are
eligible for the study. Selected subjects with incomplete Sj(SqrRoot)(Delta)gren s Disease or
who are excluded from the European American criteria may also be eligible. Screening will be
done on the Characterization of Diseases with Salivary Gland Involvement protocol (15-D-0051)
prospectively or on the previous screening protocol (84-D-0056).
Description of the Study
This is a longitudinal observational study. All subjects will have core evaluations
(approximately biannually) during a 10-year period. Additional evaluations may be required if
there is a significant change in the clinical condition of subjects likely related to SjD or
sicca syndrome or to provide additional research samples or clinical data for the
pathogenesis studies. 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 Sj(SqrRoot)(Delta)gren s Disease. Samples
labeled with a code without any personal identifiers may be shared with researchers in and
outside the NIH. DNA will be collected for genetic studies related to Sj(SqrRoot)(Delta)gren
s Disease and related conditions.