跳至主要内容
临床试验/NCT06932497
NCT06932497进行中(未招募)不适用

Gemelli Longitudinal Cohort on Long-term Outcomes in RheumatIc diseAses

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2025年4月7日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
5,000
试验地点
1
主要终点
HAQ-DI

研究概览

简要总结

Chronic rheumatic diseases (CRDs) are major determinant of disability in the general population. Particularly, immune-mediated CRDs also represent a significant cause of morbidity and mortality among younger individuals. CRDs lead to substantial direct costs related to healthcare service use and pharmacological expenses, as well as indirect social costs. Proper prognostic stratification of CRD patients could tailor diagnostic and therapeutic interventions to improve clinical outcomes and strategically allocate healthcare resources while minimizing both direct and indirect costs.

Reported prognostic predictors in CRDs are largely derived from randomized therapeutic trials and therefore mostly reflect short-term outcomes under controlled experimental conditions. A real-life research could provide crucial information about long-term outcomes including survival, impact of comorbidities and polypharmacotherapy, and inform on healthcare costs.

The Gemelli longitudinal cohort on Long-term Outcomes in Rheumatic Diseases (GLORIA) aims to define shared and disease-specific predictors of long-term disability, organ damage, mortality, and healthcare costs for patients under the care of the Division of Rheumatology at the Fondazione Policlinico Universitario A. Gemelli IRCCS - Catholic University of the Sacred Heart in Rome. This study will adopt an electronic database identified for collecting and analyze data (REDcap Research Electronic Data Capture platform), compliant with general data protection regulation (GDPR) law.

Predictors will be selected from routinely collected demographic, clinical, laboratory, histological, and instrumental data. Additional blood samples may be collected from newly diagnosed patients or when diagnostic or therapeutic interventions are required according to clinical practice. Excepted for additional collection of peripheral blood, no additional procedure will be therefore performed.

详细描述

Rationale of GLORIA Chronic rheumatic diseases (CRDs) represent a heterogeneous group of conditions with varying epidemiological, pathophysiological, and clinical aspects. CRDs are characterized substantial impact on population morbidity and mortality and relevance in terms of public health decision making and social costs. A timely and accurate definition of the prognosis for CRDs patients is crucial for improving clinical outcomes, as well as for strategically allocating healthcare resources and minimizing indirect economic and non-economic costs.

The most significant CRDs in terms of prevalence or need for intensive care fall into three main categories: autoimmune and inflammatory immune-mediated diseases, metabolic and degenerative diseases, and extra articular pain syndromes of which fibromyalgia (FM) is the most diffuse.

The category of autoimmune or inflammatory immune-mediated diseases includes conditions attributed to aberrant activation of the immune system, with the highest prevalence conditions being primary arthritis and conditions that are individually less common but collectively epidemiologically relevant such as connective tissue diseases, vasculitis, and autoinflammatory syndromes. Similarly to organ-specific autoimmune conditions, these have shown an increasing incidence in the last decades. Most of them are associated with multi-organ involvement and potentially life-threatening complications.

Degenerative and metabolic pathologies include primary and secondary osteoarthritis, crystal arthropathies, and metabolic bone diseases, with osteoporosis and algodystrophy being the most prevalent forms. These conditions are extensively associated with aging processes and endocrine-metabolic diseases. Their prevalence has increased over the last decades considering the demographic trends of the Italian population and concurrently with the rising incidence of closely related conditions such as the so called "metabolic syndrome". They represent a relevant morbidity burden in the general population around the world and their complications have been associated with increased mortality.

Finally, FM is the most common cause of chronic widespread musculoskeletal pain particularly in women between 20 and 55 years of age. FM is often accompanied by fatigue, cognitive disorders, psychiatric symptoms, and multiple somatic symptoms. It is characterized by forms of central sensitization in the absence of documented inflammation affecting joints, muscles, ligaments, and tendons.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

HAQ-DI

时间窗: 10 years

Degree of disability in CRD patients, quantified according to the Health Assessment Questionnaire-Disability Index.

次要结局

  • Drug and surgery access(10 years)
  • Mortality(10 years)
  • Heathcare service access(10 years)
  • Complications(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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