Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- GCA Diagnostic Method
研究概览
简要总结
The purpose of this study is to describe medical practices in patients with GCA in terms of patient journey, diagnostic methods and specific GCA treatments since diagnosis.
详细描述
This is a cross-sectional, non-interventional, national (France), multicentre study, conducted on a population of 300 patients with GCA, to describe GCA management and patient characteristics.
The study will be conducted in accordance with the professional code of ethics and the good epidemiological practice guidelines developed by the Association of French-Speaking Epidemiologists.
The information will be collected during a single visit to the internist or rheumatologist as part of the usual management of the patient with GCA. The physician will not perform any additional examinations specific to the study. The physician will inform the patient about the study before inclusion and seek her/his non-opposition. A patient information form will be given to each patient by the physician. Patients who are eligible to participate in the study and who verbally accept automatic processing of their personal data, will be included in the study.
Data will be collected from the medical file and from patient questionnaires on health status (SF-36 [36-Item Short Form Survey Instrument], EQ5D [EuroQol-5 Dimensions]) and fatigue (FACIT-fatigue). In addition, GCA activity will be evaluated using a global arteritis activity Visual Analog Scale (VAS) to be completed by the patient and the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 50 years old.
- •Suffering from GCA as per investigator judgement, newly diagnosed or not.
- •Starting or under treatment for GCA.
- •Informed verbally and in writing about this study and not objecting to their data being electronically processed or subjected to data quality control.
- •Non-inclusion Criteria:
- •Unable to consent
- •Participation to a randomised controlled clinical trial
排除标准
- 未提供
结局指标
主要结局
GCA Diagnostic Method
时间窗: Baseline only
Proportions of each diagnostic method used
Patient Journey : Physicians Who Referred the Patient
时间窗: Baseline only
Proportion of patients for each physician specialty that referred the patient
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA
时间窗: Baseline only
Physician encountered by the patient at least one time since the first events related to GCA (Multiple answers possible, If a patient encountered a medical speciality more than one time, this speciality will be counted only once)
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
时间窗: Baseline only
Number of patients with at least one immunosuppressant ongoing at inclusion
GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis
时间窗: Baseline only
GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis.
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
时间窗: Baseline only
Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Patient Journey : Time to GCA Diagnosis
时间窗: Baseline only
Time between GCA signs/symptoms and diagnosis
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
时间窗: baseline only
Number of patients with at least one GC kinetic ongoing at inclusion
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion
时间窗: Baseline only
Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion
时间窗: Baseline only
Number of patients with at least one targeted biologic therapy ongoing at inclusion
次要结局
- Proportion of Incident Patients(Baseline only)
- Comorbidities Related to GCs(Baseline only)
- Global Arteritis Activity(Baseline only)
- Physician Type of Practice(Baseline only)
- Physician Number of Years of Practice(Baseline only)
- Proportion of Prevalent Patients(Baseline only)
- GCA Duration(Baseline only)
- PRO Scores: FACIT-Fatigue Questionnaire(Baseline only)
- Physician Medical Specialty(Baseline only)
- Treatments in Patients With Comorbidities Related to GCs(Baseline only)
- GCA Clinical Form(Baseline only)
- PRO Scores: EQ5D-3L Questionnaire(Baseline only)
- GCA Initial Presentation(Baseline only)
- Patients With GCA Complications(Baseline only)
- Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire(Baseline only)
- Physician Characteristics: Number of GCA Diagnosis(Baseline only)