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临床试验/NL-OMON55626
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.

研究者

发起方
reumatologie

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