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临床试验/NCT07150000
NCT07150000招募中不适用

CARe RAiSE Study - Clinical Assessment for Rheumatologic Disease - Research and Advancement in Safety and Efficacy

University of Bonn1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Changes in Immune Cell Phenotype in the Ex-Vivo Assay

研究概览

简要总结

The CARe RAiSE project represents a pioneering translational initiative aimed at advancing precision medicine in the treatment of autoimmune rheumatic diseases. The primary objective is the development and implementation of an innovative cell-based ex vivo assay that enables individualized prediction of therapeutic response to disease-modifying antirheumatic drugs (DMARDs). By identifying the most effective treatment option for each patient, this approach seeks to enhance therapeutic efficacy, reduce time to clinical response, and minimize healthcare costs.

Despite the availability of numerous DMARDs, clinical decision-making remains largely empirical due to considerable interindividual variability in treatment response. This frequently results in a prolonged trial-and-error process, placing a significant burden on patients and the healthcare system. CARe RAiSE aims to overcome this limitation by providing a functional diagnostic tool that can predict a patient's immunological response to specific DMARDs prior to treatment initiation.

The assay is based on peripheral blood mononuclear cells (PBMCs) obtained from individual patients, enabling a physiologically relevant assessment of immune responsiveness to targeted therapies. Combining high-content imaging with homogeneous well-based cytokine and inflammasome activity assays, the platform allows for a detailed single-cell analysis of inflammatory pathways. These data are used to generate predictive signatures of treatment response, thereby facilitating a mechanistically informed and personalized therapeutic strategy.

Through this approach, CARe RAiSE introduces a scientifically grounded, efficient, and patient-specific method for DMARD selection, with the potential to substantially improve patient outcomes and reduce the socioeconomic impact of autoimmune rheumatic diseases.

详细描述

Study Overview and Work Packages

This study aims to functionally characterize individual immune responses in patients with autoimmune and autoinflammatory rheumatic diseases using immunological and molecular approaches to develop predictive models of response to immunomodulatory therapies. The study follows a hybrid design with prospective-longitudinal and cross-sectional components and includes the following cohorts:

Newly diagnosed cohort: Patients with treatment-naïve disease. Sampling at baseline (V0), follow-up at 6 and 12 weeks (V1/V2), with optional sampling at disease relapse (VRel) and after treatment adjustment (VTher).

Cross-sectional cohort: Patients under ongoing immunomodulatory therapy. Single-timepoint sampling (Vc), with optional VRel and VTher.

Healthy control cohort: Age- and sex-matched healthy individuals. Single-timepoint sampling equivalent to V0 (Vk).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants aged ≥ 18 years
  • Signed written informed consent to participate voluntarily in the study.
  • Confirmed diagnosis (by the treating physician) of one of the following autoimmune or autoinflammatory rheumatic diseases:
  • Rheumatoid arthritis (RA)
  • Psoriatic arthritis (PsA)
  • Axial spondyloarthritis (axSpA)
  • Giant cell arteritis (GCA)
  • Connective tissue diseases, including:
  • Systemic lupus erythematosus (SLE)
  • Systemic sclerosis (SSc)
  • Mixed connective tissue disease (MCTD)
  • Idiopathic inflammatory myopathies (IIM)
  • ANCA-associated vasculitides (AAV), including:
  • Microscopic polyangiitis (MPA)
  • Granulomatosis with polyangiitis (GPA)
  • Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Autoinflammatory diseases, including
  • Familial Mediterranean fever (FMF)
  • Cryopyrin-associated periodic syndromes (CAPS)
  • TNF receptor-associated periodic syndrome (TRAPS)
  • Adult-onset Still's disease (AOSD)

排除标准

  • Refusal to participate in the study or inability to provide informed consent.
  • Inclusion Criteria - Healthy Control Group:
  • Participants aged ≥ 18 years (capable of providing informed consent).
  • Signed written informed consent to participate voluntarily in the study.
  • Exclusion Criteria - Healthy Control Group:
  • - Presence of a known or active rheumatologic disease.

结局指标

主要结局

Changes in Immune Cell Phenotype in the Ex-Vivo Assay

时间窗: Baseline. Follow-up after 6 weeks, 3 months, 6 months, 12 months and in case of relapse or therapy change. Cross sectional: Baseline. Healthy Controls: Baseline.

Identification and quantification of immune cell subtypes, using the Ex-Vivo Essay. Unit of Measure: Changes in levels (percentages).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentin Schäfer

Univ.-Prof. Dr. med. MUDr

University Hospital, Bonn

研究点 (1)

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