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

Chugai Pharmaceutical

Status: Completed

Conditions: Giant Cell Arteritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03658889

CPF_ARTEMIS2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

306 participants in 1 patient group

Patients under treatment(s) for GCA

Description:

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