The objective of this study is to investigate of inflammatory tissues of patients with SSj, CLE and SSc contain autoreactive B and T cell expansions that are differently activated compared to other B and T cell expansions in patients with SSj, CLE…
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 and T cell clones
compared to other B and T cell clones in inflammatory tissues of SSj versus CLE
and SSc patients.
Secondary outcome
not applicable
Background summary
Sjögren's syndrome (SSj), cutaneous lupus erythematodus (CLE) and systemic
sclerosis (SSc) are chronic inflammatory
conditions characterized by inflammation and damage of tissues. The precise
cause of SSj, CLE and SSc are unknown.
On the one hand, SSj, CLE and SSc have been considered to be autoimmune
diseases, in which autoreactive B and
T cell clones recognize tissue autoantigens, expand and drive tissue
destruction. On the other hand, SSj, CLE and SSc
have been thought to be caused by primary inflammatory activation of innate
immune cells, through for instance direct
infection or stimulation by toxins released by commensal microbes, resulting in
production of inflammatory mediators
that attract immune cells among which a mixed repertoire of allo- and
autoreactive B and T cells. ln this context, locally
expanded B and T cell clones might exert proinflammatory or immunoregulatory
functions.
Study objective
The objective of this study is to investigate of inflammatory tissues of
patients with SSj, CLE and SSc contain autoreactive B and T cell expansions
that are differently activated compared to other B and T cell expansions in
patients with SSj, CLE and SSc.
Study design
translational investigation in a transversal cohort
Study burden and risks
SSj, CLE and SSc patients 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 SSj patients 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 SSc and CLE patients during the second visit a skin biopsy
will be taken from involed and non-involved skin.
Patients with SSj, CLE and SSc will be asked for separate consent to take a
lymph node biopsy. This will be performed at a
third study visit. The lymph node biopsy will be taken under ultrasound
guidance and lokal anaesthesics. All 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. All biopsy
procedures are tolerated well. After both
procedures a local hematoma may occur.
Geert Grooteplein-zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
lnclusion criteria for Sjögren's syndrome (SSj) 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 antinuclear (ANA),
anti-SSA and/or anti-SSB antibodies.
Inclusion criteria for CLE patients are: diagnosis of subacute cutaneous lupus
erythematosus (SCLE) or SLE with cutaneous lupus according to the Düsseldorf
classification criteria . Presence of anti-nuclear (ANA), anti-SSA and/or
anti-SSB antibodies. Active skin disease as assessed by the treating physician.
lnclusion criteria for the SSc patients are: diagnosis of early diffuse
cutaneous SSc, according to the VEDOSS criteria defined as having a diffuse
skin involvement, presence of anti-nuclear antibodies (ANA) a disease duration
(from fìrst non-ñaynaud symptom) of < 3 years and progressive disease as
defined by an increase in mean Rodnan skin score (hnSS) > 10 points or > 25% in
the past year. Patients will be selected with skin involvement of the legs,
which allows the analysis of an inguinal lymph node as locoregional lymph node.
Exclusion criteria
Exclusion criteria for both SSj patients and SSc 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 lmmunodeficiëncy 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 | NL67672.091.22 |