Giant Cell ArteritisARTEMISNCT03658889
Assessment of Giant Cell Arteritis Medical Practices in France
An observational study of Giant Cell Arteritis, run by Chugai Pharma France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2018to 9 Nov 2018
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional, Multicentre, Non-interventional Study to Assess 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.
Read the 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.
- Conditions
- Giant Cell Arteritis
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients under treatment(s) for GCA | Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Journey : Physicians Who Referred the Patient
Proportion of patients for each physician specialty that referred the patient
Measured: Baseline only
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA
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)
Measured: Baseline only
Patient Journey : Time to GCA Diagnosis
Time between GCA signs/symptoms and diagnosis
Measured: Baseline only
GCA Diagnostic Method
Proportions of each diagnostic method used
Measured: Baseline only
GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis
GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis.
Measured: Baseline only
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
Number of patients with at least one GC kinetic ongoing at inclusion
Measured: baseline only
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Measured: Baseline only
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
Number of patients with at least one immunosuppressant ongoing at inclusion
Measured: Baseline only
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion
Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion
Measured: Baseline only
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion
Number of patients with at least one targeted biologic therapy ongoing at inclusion
Measured: Baseline only
Secondary outcomes (16)
Comorbidities Related to GCs
Comorbidities related/ aggravated by the use of GCs according to the investigator's judgment in at least 2 patients (by SOC)
Measured: Baseline only
Treatments in Patients With Comorbidities Related to GCs
Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs
Measured: Baseline only
Proportion of Incident Patients
Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion
Measured: Baseline only
Proportion of Prevalent Patients
Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion
Measured: Baseline only
GCA Duration
Time since GCA diagnosis for overall population, prevalent and incident patients
Measured: Baseline only
GCA Initial Presentation
Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis
Measured: Baseline only
GCA Clinical Form
Proportion of patients with at least one relapse and number of relapses
Measured: Baseline only
Patients With GCA Complications
Proportions of patients with GCA complications
Measured: Baseline only
Global Arteritis Activity
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")
Measured: Baseline only
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire
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)
Measured: Baseline only
PRO Scores: EQ5D-3L Questionnaire
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)
Measured: Baseline only
PRO Scores: FACIT-Fatigue Questionnaire
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).
Measured: Baseline only
Physician Medical Specialty
Physician characteristics: medical specialty
Measured: Baseline only
Physician Number of Years of Practice
Number of years since medical school graduation
Measured: Baseline only
Physician Type of Practice
Physician main activity (University Hospital or General Services Hospital)
Measured: Baseline only
Physician Characteristics: Number of GCA Diagnosis
Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start2 Aug 2018
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 306 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Chugai Pharma France
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ITEC Services
- Responsible party
- Sponsor
- Investigators
- Alfred MAHR, Professor, Principal investigator, alfred.mahr@aphp.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658889
- Sponsor's protocol ID
- CPF_ARTEMIS2018
- Acronym
- ARTEMIS
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2018
- Last updated
- 22 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France
- ClinicalTrials.gov ID
- NCT03658889
- Acronym / sponsor ID
- ARTEMIS / CPF_ARTEMIS2018
- Conditions
- Giant Cell Arteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Chugai Pharma FranceIndustry (pharma, biotech, devices)
- Collaborators
- ITEC Services
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 28 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients under treatment(s) for GCA | – | –Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- Unable to consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Journey : Physicians Who Referred the Patient
Time frame: Baseline only
Proportion of patients for each physician specialty that referred the patient
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)
Patient Journey : Time to GCA Diagnosis
Time frame: Baseline only
Time between GCA signs/symptoms and diagnosis
GCA Diagnostic Method
Time frame: Baseline only
Proportions of each diagnostic method used
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.
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
Time frame: baseline only
Number of patients with at least one GC kinetic ongoing at inclusion
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
Time frame: Baseline only
Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
Time frame: Baseline only
Number of patients with at least one immunosuppressant ongoing at inclusion
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
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
16 secondary outcomes
Comorbidities Related to GCs
Time frame: Baseline only
Treatments in Patients With Comorbidities Related to GCs
Time frame: Baseline only
Proportion of Incident Patients
Time frame: Baseline only
Proportion of Prevalent Patients
Time frame: Baseline only
GCA Duration
Time frame: Baseline only
GCA Initial Presentation
Time frame: Baseline only
GCA Clinical Form
Time frame: Baseline only
Patients With GCA Complications
Time frame: Baseline only
Global Arteritis Activity
Time frame: Baseline only
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire
Time frame: Baseline only
PRO Scores: EQ5D-3L Questionnaire
Time frame: Baseline only
PRO Scores: FACIT-Fatigue Questionnaire
Time frame: Baseline only
Physician Medical Specialty
Time frame: Baseline only
Physician Number of Years of Practice
Time frame: Baseline only
Physician Type of Practice
Time frame: Baseline only
Physician Characteristics: Number of GCA Diagnosis
Time frame: Baseline only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Giant Cell Arteritis
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Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
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The Applanation Tonometry in GCA Pilot
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred MAHR, Professor principal investigator
alfred.mahr@aphp.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis, run by Chugai Pharma France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Journey : Physicians Who Referred the Patient (time frame: Baseline only). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.