Assessment of Giant Cell Arteritis Medical Practices in France

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France

Conditions
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Giant Cell Arteritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients under treatment(s) for GCA<br>Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Journey : Physicians Who Referred the Patient | Proportion of patients for each physician specialty that referred the patient | Baseline only | 
| Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | 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) | Baseline only | 
| Patient Journey : Time to GCA Diagnosis | Time between GCA signs/symptoms and diagnosis | Baseline only | 
| GCA Diagnostic Method | Proportions of each diagnostic method used | Baseline only | 
| GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis | GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis. | Baseline only | 
| GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion | Number of patients with at least one GC kinetic ongoing at inclusion | baseline only | 
| GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Immunosuppressants for GCA taken since diagnosis and stopped before inclusion | Baseline only | 
| GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Number of patients with at least one immunosuppressant ongoing at inclusion | Baseline only | 
| GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion | Baseline only | 
| GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Number of patients with at least one targeted biologic therapy ongoing at inclusion | Baseline only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities Related to GCs | Comorbidities related/ aggravated by the use of GCs according to the investigator's judgment in at least 2 patients (by SOC) | Baseline only | 
| Treatments in Patients With Comorbidities Related to GCs | Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs | Baseline only | 
| Proportion of Incident Patients | Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion | Baseline only | 
| Proportion of Prevalent Patients | Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion | Baseline only | 
| GCA Duration | Time since GCA diagnosis for overall population, prevalent and incident patients | Baseline only | 
| GCA Initial Presentation | Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis | Baseline only | 
| GCA Clinical Form | Proportion of patients with at least one relapse and number of relapses | Baseline only | 
| Patients With GCA Complications | Proportions of patients with GCA complications | Baseline only | 
| Global Arteritis Activity | Score of the physician and patient global arteritis activity on a 100 mm-visual analog scale (100mm-VAS) (Patients with physician's VAS score less than or equal to 10mm will be considered with non-active GCA, while patients with physician's VAS score greater than 10 mm will be considered with active GCA) | Baseline only | 
| Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Total and detailed scores of the self reported SF-36 questionnaire (36-Item Short Form Survey Instrument): 36 item survey measuring health-related quality-of-life. For each domains: score ranging from 0 (worst health status) to 100 (best health status) | Baseline only | 
| PRO Scores: EQ5D-3L Questionnaire | Total score of the EuroQol-5 Dimensions 3 Levels (EQ5D-3L) questionnaire and perceived current health state (100mm-EQ_VAS score, 0 = 'Worst imaginable health state' and 100 = 'Best imaginable health state) | Baseline only | 
| PRO Scores: FACIT-Fatigue Questionnaire | Total score of the 13-items Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) questionnaire. FACIT-Fatigue is an instrument that measures overall fatigue and its effects on the general functioning and daily activities through 13 questions. Each question has 5 levels: not at all, a little bit, somewhat, quite a bit, very much. Lower scores indicate greater fatigue. The total score of FACIT-Fatigue varies from 0 to 52 (score <30 = severe fatigue). | Baseline only | 
| Physician Medical Specialty | Physician characteristics: medical specialty | Baseline only | 
| Physician Number of Years of Practice | Number of years since medical school graduation | Baseline only | 
| Physician Type of Practice | Physician main activity (University Hospital or General Services Hospital) | Baseline only | 
| Physician Characteristics: Number of GCA Diagnosis | Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient | Baseline only |