Assessment of Giant Cell Arteritis Medical Practices in France
NCT ID: NCT03658889
Last Updated: 2022-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
306 participants
OBSERVATIONAL
2018-08-02
2018-11-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Patients under treatment(s) for GCA
Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
* Unable to consent
* Participation to a randomised controlled clinical trial
50 Years
ALL
No
Sponsors
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ITEC Services
OTHER
Chugai Pharma France
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Hospital of the Archet
Nice, Alpes-Maritimes, France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CPF_ARTEMIS2018
Identifier Type: -
Identifier Source: org_study_id
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