Hospital of the Archet
Nice, Alpes-Maritimes, 06202, France
NCT Number: NCT03658889
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.
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Notify Me50 year and older
All sexes
Observational
Nice, Alpes-Maritimes, 06202, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Time frame: Baseline only
Proportion of patients for each physician specialty that referred the patient
Time frame: 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)
Time frame: Baseline only
Time between GCA signs/symptoms and diagnosis
Time frame: Baseline only
Proportions of each diagnostic method used
Time frame: Baseline only
GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis.
Time frame: baseline only
Number of patients with at least one GC kinetic ongoing at inclusion
Time frame: Baseline only
Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Time frame: Baseline only
Number of patients with at least one immunosuppressant ongoing at inclusion
Time frame: Baseline only
Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion
Time frame: Baseline only
Number of patients with at least one targeted biologic therapy ongoing at inclusion
Time frame: Baseline only
Comorbidities related/ aggravated by the use of GCs according to the investigator's judgment in at least 2 patients (by SOC)
Time frame: Baseline only
Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs
Time frame: Baseline only
Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion
Time frame: Baseline only
Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion
Time frame: Baseline only
Time since GCA diagnosis for overall population, prevalent and incident patients
Time frame: Baseline only
Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis
Time frame: Baseline only
Proportion of patients with at least one relapse and number of relapses
Time frame: Baseline only
Proportions of patients with GCA complications
Time frame: 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")
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: Baseline only
Physician characteristics: medical specialty
Time frame: Baseline only
Number of years since medical school graduation
Time frame: Baseline only
Physician main activity (University Hospital or General Services Hospital)
Time frame: Baseline only
Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient
Chugai Pharma France
Industry
Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France
Acronym: ARTEMIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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