B cell Activation in Sjögren*s Syndrome Tissues Analysis

B cell Activation in Sjögren*s Syndrome Tissues Analysis - BASTA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42327

Enrollment

Registered

2015-08-24

Start date

2015-11-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheuma Sjögren

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
To determine the difference in expansion, reactivity, function and regulation of autoreactive B cell clones compared to aother B cell clones in inflammatory tissues of SS patients and lymphoid tissue of non-inflammatory controls.	—

Countries

Netherlands

Outcome results