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Trial record 19 of 179 for:    DCLRE1C

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

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ClinicalTrials.gov Identifier: NCT03658889
Recruitment Status : Recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
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 specifics 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]
Estimated Enrollment : 300 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
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine


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 : Proportions of each physicians who referred the patient [ Time Frame: Baseline only ]
    Proportions of each physicians who referred the patient

  2. Patient journey : Proportions of each physicians who followed the patient for his/her GCA [ Time Frame: Baseline only ]
    Proportions of each physicians who followed the patient for his/her GCA

  3. Patient journey : Time between GCA signs/symptoms and diagnosis [ Time Frame: Baseline only ]
    Time between GCA signs/symptoms and diagnosis

  4. Proportions of each diagnostic method used [ Time Frame: Baseline only ]
    Proportions of each diagnostic method used

  5. Previous and on-going specific GCA treatments since diagnosis [ Time Frame: Baseline only ]
    Previous and on-going specific GCA treatments since diagnosis


Secondary Outcome Measures :
  1. Comorbidities related to GCs [ Time Frame: Baseline only ]
    Comorbidities related to GCs

  2. Treatments in patients with comorbidities related to GCs [ Time Frame: Baseline only ]
    Treatments in patients with comorbidities related to GCs

  3. Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion [ Time Frame: Baseline only ]
    Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion

  4. Proportion of prevalent 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

  5. GCA duration [ Time Frame: Baseline only ]
    GCA duration

  6. Initial presentation: Proportions of patients with cranial GCA, PMR, extracranial GCA, elevated ESR/CRP and general signs [ Time Frame: Baseline only ]
    Initial presentation: Proportions of patients with cranial GCA, PMR, extracranial GCA, elevated ESR/CRP and general signs

  7. Clinical form: Proportion of patient with relapse and number of relapse [ Time Frame: Baseline only ]
    Clinical form: Proportion of patient with relapse and number of relapse

  8. Clinical form: Distribution of GCs-dependence [ Time Frame: Baseline only ]
    Clinical form: Distribution of GCs-dependence

  9. Clinical form: Proportions of patients with GCA complications [ Time Frame: Baseline only ]
    Clinical form: Proportions of patients with GCA complications

  10. Proportions of each clinical signs/symptoms of GCA activity [ Time Frame: Baseline only ]
    Proportions of each clinical signs/symptoms of GCA activity

  11. Score of the physician and patient global arteritis activity VAS [ Time Frame: Baseline only ]
    Score of the physician and patient global arteritis activity VAS

  12. PRO scores: Total and detailed scores of the SF-36 questionnaire [ Time Frame: Baseline only ]
    PRO scores: Total and detailed scores of the SF-36 questionnaire

  13. PRO scores: Total and detailed scores of the EQ5D-3L questionnaire [ Time Frame: Baseline only ]
    PRO scores: Total and detailed scores of the EQ5D-3L questionnaire

  14. PRO scores: Total and detailed scores of the FACIT-Fatigue questionnaire [ Time Frame: Baseline only ]
    PRO scores: Total and detailed scores of the FACIT-Fatigue questionnaire

  15. Physician characteristics: Demography [ Time Frame: Baseline only ]
    Physician characteristics: Demography

  16. Physician characteristics: medical specialty [ Time Frame: Baseline only ]
    Physician characteristics: medical specialty

  17. Physician characteristics: number of years of practice [ Time Frame: Baseline only ]
    Physician characteristics: number of years of practice

  18. Physician characteristics: type of practice [ Time Frame: Baseline only ]
    Physician characteristics: type of practice

  19. Physician characteristics: number of GCA diagnosis within the previous year for physicians [ Time Frame: Baseline only ]
    Physician characteristics: number of GCA diagnosis within the previous year for physicians

  20. Patient characteristics: Demography [ Time Frame: Baseline only ]
    Patient characteristics: Demography

  21. Significant past and current comorbidities of GCA patients and associated concomitant treatments [ Time Frame: Baseline only ]
    Significant past and current comorbidities of GCA patients and associated concomitant treatments



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


Contacts
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Contact: Isabelle IDIER, Doctor +33 (0) 1 56 37 44 89 idier@chugai-pharm.fr
Contact: Frédéric VALENTI +33 (0)5 57 77 85 00 frederic.valenti@itecservices.com

Locations
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France
Hospital of the Archet Recruiting
Nice, Alpes-Maritimes, France, 06202
Contact: Viviane QUEYREL MORANNE, PI    +33 (0) 6 72 41 76 99    queyrel.v@chu-nice.fr   
Principal Investigator: Viviane QUEYREL MORANNE         
Sponsors and Collaborators
Chugai Pharma France
ITEC Services
Investigators
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Principal Investigator: Alfred MAHR, Professor alfred.mahr@aphp.fr

Additional Information:

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Responsible Party: Chugai Pharma France
ClinicalTrials.gov Identifier: NCT03658889     History of Changes
Other Study ID Numbers: CPF_ARTEMIS2018
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
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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Arteritis
Giant Cell Arteritis
Polymyalgia Rheumatica
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