NL-OMON55626尚未招募不适用
B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis Tissues Analysis 2 - BASTA2
reumatologie0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •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.
排除标准
- •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.
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