Assessment of Giant Cell Arteritis Medical Practices in France

Giant Cell Arteritis Clinical Trial

— ARTEMIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658889
• Other study ID #: CPF_ARTEMIS2018
• Status: Completed
• Start date: August 2, 2018
• Est. completion date: November 9, 2018

Study information

• Verified date: July 2022
• Source: Chugai Pharma France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Locations

Country	Name	City	State
France	Hospital of the Archet	Nice	Alpes-Maritimes

Sponsors (2)

Lead Sponsor	Collaborator
Chugai Pharma France	ITEC Services

Country where clinical trial is conducted

France, 

Outcome

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