B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues Analysis 2

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

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.

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 and T cell clones<br /><br>compared to other B and T cell clones in inflammatory tissues of SSj versus CLE<br /><br>and SSc patients.</p><br>

Secondary Outcome Measures