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

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ClinicalTrials.gov Identifier: NCT03658889
Recruitment Status : Completed
First Posted : September 6, 2018
Results First Posted : May 28, 2020
Last Update Posted : June 16, 2020
Sponsor:
Collaborator:
ITEC Services
Information provided by (Responsible Party):
Chugai Pharma France

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.

Condition or disease
Giant Cell Arteritis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 306 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France
Actual Study Start Date : August 2, 2018
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658889


Locations
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France
Hospital of the Archet
Nice, Alpes-Maritimes, France, 06202
Sponsors and Collaborators
Chugai Pharma France
ITEC Services
Investigators
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Principal Investigator: Alfred MAHR, Professor alfred.mahr@aphp.fr
  Study Documents (Full-Text)

Documents provided by Chugai Pharma France:
Study Protocol  [PDF] September 17, 2018
Statistical Analysis Plan  [PDF] January 4, 2019

Additional Information:

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Responsible Party: Chugai Pharma France
ClinicalTrials.gov Identifier: NCT03658889    
Other Study ID Numbers: CPF_ARTEMIS2018
First Posted: September 6, 2018    Key Record Dates
Results First Posted: May 28, 2020
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases