B cell Activation in Sjögren*s Syndrome Tissues Analysis
- Conditions
- rheumaSjögren1000381610023213
- Registration Number
- NL-OMON42327
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion criteria for Sjögren's syndrome (SS) patients are: diagnosis of primary SS according to the European American consensus group criteria, grade 3 or 4 Chisholm score in salivary gland biopsy and presence of anti-nuclear (ANA), anti-SSA and/or anti-SSB antibodies. Inclusion criteria for the non-SS sicca patients are: persistent sensation of dry eyes and dry mouth with no objective evidence of SS, including low Chisholm score in glandular biopsy (grade 0 or 1), absence of ANA, anti-SSA, anti-SSB, anti-immunoglobulin G (rheumatoid factor) and anti-cyclic citrullinated peptide antibodies.
Exclusion criteria for both SS patients and non-SS sicca patients are presence of active concurrent inflammatory or infectious condition, current or previous use of biologic treatment, previous other systemic autoimmune disease diagnosis or positive serology for hepatitis C or Human Immunodeficiëncy Virus.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the difference in expansion, reactivity, function and regulation<br /><br>of autoreactive B cell clones compared to aother B cell clones in inflammatory<br /><br>tissues of SS patients and lymphoid tissue of non-inflammatory controls. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable</p><br>