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Completed

NCT Number: NCT03658889

Assessment of 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patient Journey : Physicians Who Referred the Patient

    Time frame: Baseline only

    Proportion of patients for each physician specialty that referred the patient

  2. Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA

    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)

  3. Patient Journey : Time to GCA Diagnosis

    Time frame: Baseline only

    Time between GCA signs/symptoms and diagnosis

  4. GCA Diagnostic Method

    Time frame: Baseline only

    Proportions of each diagnostic method used

  5. GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis

    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.

  6. GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion

    Time frame: baseline only

    Number of patients with at least one GC kinetic ongoing at inclusion

  7. GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion

    Time frame: Baseline only

    Immunosuppressants for GCA taken since diagnosis and stopped before inclusion

  8. GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion

    Time frame: Baseline only

    Number of patients with at least one immunosuppressant ongoing at inclusion

  9. GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion

    Time frame: Baseline only

    Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion

  10. GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion

    Time frame: Baseline only

    Number of patients with at least one targeted biologic therapy ongoing at inclusion

Secondary outcomes

  1. Comorbidities Related to GCs

    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)

  2. Treatments in Patients With Comorbidities Related to GCs

    Time frame: Baseline only

    Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs

  3. Proportion of Incident Patients

    Time frame: Baseline only

    Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion

  4. Proportion of Prevalent Patients

    Time frame: Baseline only

    Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion

  5. GCA Duration

    Time frame: Baseline only

    Time since GCA diagnosis for overall population, prevalent and incident patients

  6. GCA Initial Presentation

    Time frame: Baseline only

    Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis

  7. GCA Clinical Form

    Time frame: Baseline only

    Proportion of patients with at least one relapse and number of relapses

  8. Patients With GCA Complications

    Time frame: Baseline only

    Proportions of patients with GCA complications

  9. Global Arteritis Activity

    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")

  10. Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire

    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)

  11. PRO Scores: EQ5D-3L Questionnaire

    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)

  12. PRO Scores: FACIT-Fatigue Questionnaire

    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).

  13. Physician Medical Specialty

    Time frame: Baseline only

    Physician characteristics: medical specialty

  14. Physician Number of Years of Practice

    Time frame: Baseline only

    Number of years since medical school graduation

  15. Physician Type of Practice

    Time frame: Baseline only

    Physician main activity (University Hospital or General Services Hospital)

  16. Physician Characteristics: Number of GCA Diagnosis

    Time frame: Baseline only

    Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient

Sponsors and collaborators

Lead sponsor

Chugai Pharma France

Industry

Collaborators

  • ITEC Services

Registry information

Official study title

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

Acronym: ARTEMIS

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 6, 2018
Registry last updated
Jul 22, 2022

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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