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.
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.
Study Type
OBSERVATIONAL
Enrollment
306
Hospital of the Archet
Nice, Alpes-Maritimes, France
Patient Journey : Physicians Who Referred the Patient
Proportion of patients for each physician specialty that referred the patient
Time frame: 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)
Time frame: Baseline only
Patient Journey : Time to GCA Diagnosis
Time between GCA signs/symptoms and diagnosis
Time frame: Baseline only
GCA Diagnostic Method
Proportions of each diagnostic method used
Time frame: 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.
Time frame: Baseline only
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
Number of patients with at least one GC kinetic ongoing at inclusion
Time frame: baseline only
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Time frame: Baseline only
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
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Number of patients with at least one immunosuppressant ongoing at inclusion
Time frame: 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
Time frame: 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
Time frame: Baseline only
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)
Time frame: 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
Time frame: Baseline only
Proportion of Incident Patients
Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion
Time frame: Baseline only
Proportion of Prevalent Patients
Proportion of prevalent patients: patients with a diagnosis of GCA \> 6 weeks from inclusion
Time frame: Baseline only
GCA Duration
Time since GCA diagnosis for overall population, prevalent and incident patients
Time frame: Baseline only
GCA Initial Presentation
Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis
Time frame: Baseline only
GCA Clinical Form
Proportion of patients with at least one relapse and number of relapses
Time frame: Baseline only
Patients With GCA Complications
Proportions of patients with GCA complications
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Baseline only
Physician Medical Specialty
Physician characteristics: medical specialty
Time frame: Baseline only
Physician Number of Years of Practice
Number of years since medical school graduation
Time frame: Baseline only
Physician Type of Practice
Physician main activity (University Hospital or General Services Hospital)
Time frame: 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
Time frame: Baseline only