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

B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues Analysis 2 - BASTA2

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55626
Enrollment
20
Registered
2019-05-16
Start date
2019-06-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Cutaneous Lupus Erythematodus Sjögren Systemic Sclerosis

Interventions

None listed

Sponsors

reumatologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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: 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 outcomes

Primary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)