Assessment of Giant Cell Arteritis Medical Practices in France

Completed

Conditions: Giant Cell Arteritis

Registration Number: NCT03658889

Lead Sponsor: Chugai Pharma France

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 306

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

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GCA Diagnostic Method	Baseline only	Proportions of each diagnostic method used
Patient Journey : Physicians Who Referred the Patient	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	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	Baseline only	Number of patients with at least one immunosuppressant ongoing at inclusion
GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis	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	Baseline only	Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Patient Journey : Time to GCA Diagnosis	Baseline only	Time between GCA signs/symptoms and diagnosis
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion	baseline only	Number of patients with at least one GC kinetic ongoing at inclusion
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion	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	Baseline only	Number of patients with at least one targeted biologic therapy ongoing at inclusion

Secondary Outcome Measures

Name	Time	Method
GCA Duration	Baseline only	Time since GCA diagnosis for overall population, prevalent and incident patients
Proportion of Incident Patients	Baseline only	Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion
Comorbidities Related to GCs	Baseline only	Comorbidities related/ aggravated by the use of GCs according to the investigator's judgment in at least 2 patients (by SOC)
Global Arteritis Activity	Baseline only	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")
Physician Type of Practice	Baseline only	Physician main activity (University Hospital or General Services Hospital)
Physician Number of Years of Practice	Baseline only	Number of years since medical school graduation
Proportion of Prevalent Patients	Baseline only	Proportion of prevalent patients: patients with a diagnosis of GCA \> 6 weeks from inclusion
PRO Scores: FACIT-Fatigue Questionnaire	Baseline only	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).
Physician Medical Specialty	Baseline only	Physician characteristics: medical specialty
Treatments in Patients With Comorbidities Related to GCs	Baseline only	Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs
GCA Clinical Form	Baseline only	Proportion of patients with at least one relapse and number of relapses
PRO Scores: EQ5D-3L Questionnaire	Baseline only	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)
GCA Initial Presentation	Baseline only	Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis
Patients With GCA Complications	Baseline only	Proportions of patients with GCA complications
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire	Baseline only	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)
Physician Characteristics: Number of GCA Diagnosis	Baseline only	Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient