The objective of this study is to investigate of inflammatory tissues of patients with SS contain autoreactive B cell expansions that are differently activated compared to other B cell expansions in patients with SS and in persons with salivary…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
not applicable
Background summary
Sjögren*s syndrome (SS) is a chronic inflammatory condition characterized by
inflammation of exocrine glands, frequently accompanied by inflammation of
other tissues. The precise cause of SS unknown. On the one hand, SS has been
considered to be an autoimmune disease, in which autoreactive B cell clones
recognize glandular autoantigens, expand and drive tissue destruction. On the
other hand, SS has been thought to be caused by primary inflammation of
glandular epithelial cells, through for instance viral or post-viral
inflammatory mechanisms, inducing apoptosis and production of inflammatory
mediators that attract immune cells among which a mixed repertoire of allo- and
autoreactive B cells. In this context, locally expanded B cell clones might
exert proinflammatory or immunoregulatory functions.
Study objective
The objective of this study is to investigate of inflammatory tissues of
patients with SS contain autoreactive B cell expansions that are differently
activated compared to other B cell expansions in patients with SS and in
persons with salivary gland complaints not caused by SS.
Study design
translational investigation in a transversal cohort
Study burden and risks
Cases and controls will be seen for two or three study visits. At the first
visit they will be asked questions about their disease and have to fill out two
questionaires. Hundred milliliters of blood will be drawn. For cases at the
second study visit a biopsy of an inflamed salivary gland will be taken,
similar to that taken for diagnostic purposes, under local anaesthetics. For
controls during the second visit, instead of a salivary gland biopsy an
ultrasound guided biopsy of a cervical lymph node, which are also involved in
the SS disease process, will be taken. The lymph node biopsy will be taken
under ultrasound guidance and lokal anaesthesics. Patients with SS will be
asked for separate consent to take a lymph node biopsy next to a salivary gland
biopsy. This will be performed at a third study visit. Both biopsy procedures
are performed on routine basis in clinical practice. Furthermore, we have
experience in taking lymph node biopsies for research purposes in patients with
rheumatic diseases. Both biopsy procedures are tolerated well. After both
procedures a small local hematoma may occur.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
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 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53098.091.15 |