Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658889
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
ITEC Services
Information provided by (Responsible Party):
Chugai Pharma France

Tracking Information
First Submitted Date July 11, 2018
First Posted Date September 6, 2018
Last Update Posted Date July 23, 2019
Actual Study Start Date August 2, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2018)
  • Patient journey : Proportions of each physicians who referred the patient [ Time Frame: Baseline only ]
    Proportions of each physicians who referred the patient
  • 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
  • Patient journey : Time between GCA signs/symptoms and diagnosis [ Time Frame: Baseline only ]
    Time between GCA signs/symptoms and diagnosis
  • Proportions of each diagnostic method used [ Time Frame: Baseline only ]
    Proportions of each diagnostic method used
  • Previous and on-going specific GCA treatments since diagnosis [ Time Frame: Baseline only ]
    Previous and on-going specific GCA treatments since diagnosis
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 3, 2018)
  • Comorbidities related to GCs [ Time Frame: Baseline only ]
    Comorbidities related to GCs
  • Treatments in patients with comorbidities related to GCs [ Time Frame: Baseline only ]
    Treatments in patients with comorbidities related to GCs
  • 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
  • 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
  • GCA duration [ Time Frame: Baseline only ]
    GCA duration
  • 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
  • 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
  • Clinical form: Distribution of GCs-dependence [ Time Frame: Baseline only ]
    Clinical form: Distribution of GCs-dependence
  • Clinical form: Proportions of patients with GCA complications [ Time Frame: Baseline only ]
    Clinical form: Proportions of patients with GCA complications
  • Proportions of each clinical signs/symptoms of GCA activity [ Time Frame: Baseline only ]
    Proportions of each clinical signs/symptoms of GCA activity
  • Score of the physician and patient global arteritis activity VAS [ Time Frame: Baseline only ]
    Score of the physician and patient global arteritis activity VAS
  • 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
  • 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
  • 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
  • Physician characteristics: Demography [ Time Frame: Baseline only ]
    Physician characteristics: Demography
  • Physician characteristics: medical specialty [ Time Frame: Baseline only ]
    Physician characteristics: medical specialty
  • Physician characteristics: number of years of practice [ Time Frame: Baseline only ]
    Physician characteristics: number of years of practice
  • Physician characteristics: type of practice [ Time Frame: Baseline only ]
    Physician characteristics: type of practice
  • 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
  • Patient characteristics: Demography [ Time Frame: Baseline only ]
    Patient characteristics: Demography
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Giant Cell Arteritis Medical Practices in France
Official Title Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in 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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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.
Condition Giant Cell Arteritis
Intervention Not Provided
Study Groups/Cohorts Patients under treatment(s) for GCA
Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 22, 2019)
306
Original Estimated Enrollment
 (submitted: September 3, 2018)
300
Actual Study Completion Date November 9, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03658889
Other Study ID Numbers CPF_ARTEMIS2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Chugai Pharma France
Study Sponsor Chugai Pharma France
Collaborators ITEC Services
Investigators
Principal Investigator: Alfred MAHR, Professor alfred.mahr@aphp.fr
PRS Account Chugai Pharma France
Verification Date July 2019