Assessment of Giant Cell Arteritis Medical Practices in France (ARTEMIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Giant Cell Arteritis

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.

• Study Type: Observational
• Enrollment (Actual): 306

Contacts and Locations

Study Locations

• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Hospital of the Archet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

300 patients aged at least 50 years old, suffering from GCA, starting or under treatment for GCA recruited by 150 internists and rheumatologists practicing in hospitals or private clinics in Metropolitan France will be included in the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients under treatment(s) for GCA; Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chugai Pharma France
• Collaborators: ITEC Services
• Investigators: Principal Investigator: Alfred MAHR, Professor, alfred.mahr@aphp.fr

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2018
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): November 9, 2018

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: September 3, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: CPF_ARTEMIS2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No