Clinical trial NCT03658889: Assessment of Giant Cell Arteritis Medical Practices in France
Official title: Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Lead sponsor: Chugai Pharma France
Sponsor class: INDUSTRY
Collaborators: name: ITEC Services
First posted: 2018-09-06
Enrollment: 306
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Journey : Physicians Who Referred the Patient
timeFrame: Baseline only
measure: Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA
timeFrame: Baseline only
measure: Patient Journey : Time to GCA Diagnosis
timeFrame: Baseline only
measure: GCA Diagnostic Method
timeFrame: Baseline only
measure: GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis
timeFrame: Baseline only
measure: GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
timeFrame: baseline only
measure: GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
timeFrame: Baseline only
measure: GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
timeFrame: Baseline only
measure: GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion
timeFrame: Baseline only
measure: GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion
timeFrame: Baseline only
Secondary outcomes:
measure: Comorbidities Related to GCs
timeFrame: Baseline only
measure: Treatments in Patients With Comorbidities Related to GCs
timeFrame: Baseline only
measure: Proportion of Incident Patients
timeFrame: Baseline only
measure: Proportion of Prevalent Patients
timeFrame: Baseline only
measure: GCA Duration
timeFrame: Baseline only
measure: GCA Initial Presentation
timeFrame: Baseline only
measure: GCA Clinical Form
timeFrame: Baseline only
measure: Patients With GCA Complications
timeFrame: Baseline only
measure: Global Arteritis Activity
timeFrame: Baseline only
measure: Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire
timeFrame: Baseline only
measure: PRO Scores: EQ5D-3L Questionnaire
timeFrame: Baseline only
measure: PRO Scores: FACIT-Fatigue Questionnaire
timeFrame: Baseline only
measure: Physician Medical Specialty
timeFrame: Baseline only
measure: Physician Number of Years of Practice
timeFrame: Baseline only
measure: Physician Type of Practice
timeFrame: Baseline only
measure: Physician Characteristics: Number of GCA Diagnosis
timeFrame: Baseline only
Other outcomes:
Locations:
city: Nice
country: France
facility: Hospital of the Archet
state: Alpes-Maritimes
Study officials:
affiliation: alfred.mahr@aphp.fr
name: Alfred MAHR, Professor
role: PRINCIPAL_INVESTIGATOR
References: