B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis TissuesAnalysis 2 - Basta 2

radboudumc0 个研究点目标入组 30 人开始时间: 2022年10月29日最近更新: 2023年1月30日

试验速览

暂无简介。

•General inclusion criteria are age > 50 years for patients undergoing a [89Zr] anti-CD8 PET scan because of the necessary radioactive dose for this scan.
•Inclusion criteria for SSj patients are: diagnosis of primary SSj according to the European American consensus group criteria (15) and presence of anti-nuclear (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 (22). Presence of anti-nuclear (ANA), anti-SSA and/or anti-SSB antibodies. Active skin disease as assessed by the treating physician.
•Inclusion 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 first non-Raynaud symptom) of < 3 years and progressive disease as defined by an increase in mean Rodnan skin score (mRSS) > 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Exclusion criteria for SSj, CLE 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 Immunodeficiëncy Virus.
•SSj, CLE and SSc patients will be asked for separate consent for collection of a lymph node tissue biopsy. Analysis of lymph node biopsies in patients with allow the direct comparison of autoreactive B and T cell expansions, controlling for tissue specific regulatory mechanisms.

发起方