ARTEMIS: Assessment of Giant Cell Arteritis Medical Practices in France

• Sponsor: Chugai Pharma France (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03658889
• Collaborator: ITEC Services (Other)
• Enrollment: 306
• Location: 1
• Actual Duration (Months): 3.3
• Patients Per Site Per Month: 94.1

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 306 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Cross-sectional, Multicentre, Non-interventional Study to Assess Giant Cell Arteritis Medical Practices in France
• Actual Study Start Date: Aug 2, 2018
• Actual Primary Completion Date: Nov 9, 2018
• Actual Study Completion Date: Nov 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients under treatment(s) for GCA Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA

Outcome Measures

Primary Outcome Measures

1. Patient Journey : Physicians Who Referred the Patient [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 [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 [Baseline only]

   Time between GCA signs/symptoms and diagnosis

4. GCA Diagnostic Method [Baseline only]

   Proportions of each diagnostic method used

5. GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis [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 [baseline only]

   Number of patients with at least one GC kinetic ongoing at inclusion

7. GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion [Baseline only]

   Immunosuppressants for GCA taken since diagnosis and stopped before inclusion

8. GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion [Baseline only]

   Number of patients with at least one immunosuppressant ongoing at inclusion

9. GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion [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 [Baseline only]

    Number of patients with at least one targeted biologic therapy ongoing at inclusion

Secondary Outcome Measures

1. Comorbidities Related to GCs [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 [Baseline only]

   Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs

3. Proportion of Incident Patients [Baseline only]

   Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion

4. Proportion of Prevalent Patients [Baseline only]

   Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion

5. GCA Duration [Baseline only]

   Time since GCA diagnosis for overall population, prevalent and incident patients

6. GCA Initial Presentation [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 [Baseline only]

   Proportion of patients with at least one relapse and number of relapses

8. Patients With GCA Complications [Baseline only]

   Proportions of patients with GCA complications

9. Global Arteritis Activity [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 [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 [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 [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 [Baseline only]

    Physician characteristics: medical specialty

14. Physician Number of Years of Practice [Baseline only]

    Number of years since medical school graduation

15. Physician Type of Practice [Baseline only]

    Physician main activity (University Hospital or General Services Hospital)

16. Physician Characteristics: Number of GCA Diagnosis [Baseline only]

    Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the Archet	Nice	Alpes-Maritimes	France	06202

Sponsors and Collaborators

• Chugai Pharma France
• ITEC Services

Investigators

• Principal Investigator: Alfred MAHR, Professor, [e-mail]

Study Documents (Full-Text)

• Study Protocol - Sep 17, 2018
• Statistical Analysis Plan - Jan 4, 2019

More Information

Publications

None provided.

• Responsible Party: Chugai Pharma France
• ClinicalTrials.gov Identifier: NCT03658889
• Other Study ID Numbers: CPF_ARTEMIS2018
• First Posted: Sep 6, 2018
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis

Study Results

Participant Flow

Arm/Group Title	Patients Under Treatment(s) for GCA	Physicians
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA	Physicians who recruited the patients with Giant Cell Arteritis (GCA)
Period Title: Overall Study
STARTED	308	69
COMPLETED	306	69
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Patients Under Treatment(s) for GCA	Physicians	Total
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA	Physicians who recruited the patients with Giant Cell Arteritis (GCA)	Total of all reporting groups
Overall Participants	306	69	375
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.98 (7.88)	73.98 (7.88)
Age, Customized (Count of Participants)
[50-70[ years	84 27.5%	84 121.7%
≥ 70 years	222 72.5%	222 321.7%
Sex: Female, Male (Count of Participants)
Female	206 67.3%	21 30.4%	227 60.5%
Male	100 32.7%	48 69.6%	148 39.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Physician who follows the patient (Count of Participants)
Internal Medicine	258 84.3%	258 373.9%
Rheumatologist	46 15%	46 66.7%
Geriatry	2 0.7%	2 2.9%
Patients' medical history (Count of Participants)
Vascular disorders	148 48.4%	148 214.5%
Metabolism and nutrition disorders	73 23.9%	73 105.8%
Musculoskeletal and connective tissue disorders	52 17%	52 75.4%
Cardiac disorders	41 13.4%	41 59.4%
Eye disorders	40 13.1%	40 58%
Psychiatric disorders	31 10.1%	31 44.9%
Patients' comorbidities (Count of Participants)
Vascular disorders	140 45.8%	140 202.9%
Metabolism and nutrition disorders	79 25.8%	79 114.5%
Musculoskeletal and connective tissue disorders	43 14.1%	43 62.3%
Cardiac disorders	41 13.4%	41 59.4%
Psychiatric disorders	37 12.1%	37 53.6%
Treatments concomitant to diagnosis (Count of Participants)
Antiplatelets	68 22.2%	68 98.6%
Statins	40 13.1%	40 58%
Antiosteoporotics	26 8.5%	26 37.7%
Antihypertensives	141 46.1%	141 204.3%
Antidiabetics	25 8.2%	25 36.2%
Inhibitors of the proton pump	67 21.9%	67 97.1%
Hypnotics	29 9.5%	29 42%
Antidepressants	22 7.2%	22 31.9%
CA Vit D	22 7.2%	22 31.9%
Other	53 17.3%	53 76.8%
Treatments concomitant to inclusion (Count of Participants)
Antiplatelets	158 51.6%	158 229%
Statins	64 20.9%	64 92.8%
Antiosteoporotics	112 36.6%	112 162.3%
Antihypertensives	152 49.7%	152 220.3%
Antidiabetics	48 15.7%	48 69.6%
Inhibitors of the proton pump	130 42.5%	130 188.4%
Hypnotics	35 11.4%	35 50.7%
Antidepressants	31 10.1%	31 44.9%
CA Vit D	70 22.9%	70 101.4%
Other	79 25.8%	79 114.5%

Outcome Measures

1. Primary Outcome

Title	Patient Journey : Physicians Who Referred the Patient
Description	Proportion of patients for each physician specialty that referred the patient
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
General Practitioner	171 55.9%
Ophthalmologist	31 10.1%
Neurologist	21 6.9%
Emergency	17 5.6%
Internist	13 4.2%
Rheumatologist	15 4.9%
Other	12 3.9%
Anatomical Pathologist	0 0%
Angiologist/Vascular doctor	7 2.3%
Cardiologist	10 3.3%
Surgeon/Vascular surgeon	3 1%
Endocrinologist/Diabetologist	1 0.3%
Gastro-enterologist	0 0%
Geriatrician	3 1%
Ear, Nose and Throat specialist (ENT)	0 0%
Pulmonologist	1 0.3%
Radiologist	1 0.3%

2. Primary Outcome

Title	Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA
Description	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)
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
General Practitioner	260 85%
Ophthalmologist	88 28.8%
Neurologist	38 12.4%
Emergency	54 17.6%
Internist	59 19.3%
Rheumatologist	42 13.7%
Anatomical pathologist	3 1%
Angiologist/Vascular surgeon	17 5.6%
Cardiologist	20 6.5%
Surgeon/Vascular surgeon	9 2.9%
Endocrinologist/Diabetologist	3 1%
Gastro-enterologist	6 2%
Geriatrician	3 1%
Ear, Nose, Throat specialist (ENT)	9 2.9%
Pulmonologist	5 1.6%
Radiologist	7 2.3%
Other	30 9.8%

3. Primary Outcome

Title	Patient Journey : Time to GCA Diagnosis
Description	Time between GCA signs/symptoms and diagnosis
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Analysis population (missing data for 2 patients)

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	304
Median (Inter-Quartile Range) [months]	1.00

4. Primary Outcome

Title	GCA Diagnostic Method
Description	Proportions of each diagnostic method used
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Patients for whom the data is filled (ESR, n=285; C-Reactive Protein [CRP], n=275; Temporal Artery Biopsy [TAB], n=294; High resolution echo Doppler, n=292; MRI of the temporal arteries, n=304; 18 Fluorodeoxyglucose-positron emission tomography [18FDG-PET], n=280; Aortic angio-CT, n=293)

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Erythrocyte Sedimentation Rate (ESR	154 50.3%
C-Reactive Protein (CRP)	266 86.9%
Biopsy of the Temporal Artery (TAB)	249 81.4%
High resolution color Doppler ultrasound	91 29.7%
MRI of the temporal arteries	20 6.5%
18FDG PET	74 24.2%
Aortic angio-CT	87 28.4%

5. Primary Outcome

Title	GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis
Description	GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis.
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Current dose at inclusion	9.00
Total cumulative dose	4305.00

6. Primary Outcome

Title	GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
Description	Number of patients with at least one GC kinetic ongoing at inclusion
Time Frame	baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Count of Participants [Participants]	273 89.2%

7. Primary Outcome

Title	GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
Description	Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

among analysis population, 27 patients have taken at least one immunosuppressant since diagnosis and stopped before inclusion

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	27
Azathioprine	2
Cyclophosphamide	1
Cyclosporine	0
Leflunomide	1
Methotrexate	25
Mycophenolate Mofetil	0
Other	0

8. Primary Outcome

Title	GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
Description	Number of patients with at least one immunosuppressant ongoing at inclusion
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Among analysis population, 35 Patient had at least one immunosuppressant ongoing at inclusion

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	35
Azathioprine	0 0%
Cyclophosphamide	0 0%
Cyclosporine	0 0%
Leflunomide	0 0%
Methotrexate	35 11.4%
Mycophenolate Mofetil	0 0%
Other	0 0%

9. Primary Outcome

Title	GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion
Description	Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Among analysis population, 8 patients have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	8
Adalimumab	1
Abatacept	0
Etanercept	0
Infliximab	0
Tocilizumab	9
Other	0

10. Primary Outcome

Title	GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion
Description	Number of patients with at least one targeted biologic therapy ongoing at inclusion
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Among analysis population, 45 patients had at least one targeted biologic therapy ongoing at inclusion

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	45
Adalimumab	0
Abatacept	0
Etanercept	0
Infliximab	1
Tocilizumab	44
Other	0

11. Secondary Outcome

Title	Comorbidities Related to GCs
Description	Comorbidities related/ aggravated by the use of GCs according to the investigator's judgment in at least 2 patients (by SOC)
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Cardiac disorders	5 1.6%
Endocrine disorders	2 0.7%
Eye disorders	9 2.9%
Gastrointestinal disorders	4 1.3%
Hepatobiliary disorders	2 0.7%
Infections and infestations	10 3.3%
Injury, poisoning and procedural complications	7 2.3%
Investigations	4 1.3%
Metabolism and nutrition disorders	44 14.4%
Musculoskeletal and connective tissue disorders	25 8.2%
Nervous system disorders	7 2.3%
Psychiatric disorders	18 5.9%
Renal and urinary disorders	2 0.7%
Respiratory, thoracic and mediastinal disorders	3 1%
Surgical and medical procedures	4 1.3%
Vascular disorders	33 10.8%

12. Secondary Outcome

Title	Treatments in Patients With Comorbidities Related to GCs
Description	Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Count of Participants [Participants]	98 32%

13. Secondary Outcome

Title	Proportion of Incident Patients
Description	Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Count of Participants [Participants]	39 12.7%

14. Secondary Outcome

Title	Proportion of Prevalent Patients
Description	Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Count of Participants [Participants]	267 87.3%

15. Secondary Outcome

Title	GCA Duration
Description	Time since GCA diagnosis for overall population, prevalent and incident patients
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Overall analysis population: N=306 / Prevalent patients (GCA diagnosis>6weeks), N=267 / Incident patients (GCA diagnosis ≤ 6weeks), N=39

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Overall population	13.00
Prevalent patients	15.00
Incident patients	0.60

16. Secondary Outcome

Title	GCA Initial Presentation
Description	Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
at least one cranial manifestation	271 88.6%
at least one PMR symptom	148 48.4%
at least one extracranial event (excl. PMR)	108 35.3%
Value of ESR (mm/1st h) > 50 mm/h	129 42.2%
at least one general sign	227 74.2%

17. Secondary Outcome

Title	GCA Clinical Form
Description	Proportion of patients with at least one relapse and number of relapses
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Prevalent patients

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	267
Patients with 1 relapse	69 22.5%
Patients with 2 relapses	32 10.5%
Patients with 3 relapses	11 3.6%
Patients with 4 relapses	6 2%
Patients with 5 relapses	4 1.3%

18. Secondary Outcome

Title	Patients With GCA Complications
Description	Proportions of patients with GCA complications
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Count of Participants [Participants]	48 15.7%

19. Secondary Outcome

Title	Global Arteritis Activity
Description	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")
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	306
Patient VAS score	18.00
Physician VAS score	4.00

20. Secondary Outcome

Title	Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire
Description	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)
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Analysis population, SF-36 scores were missing for 11 patients

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	295
Physical functioning	70.00
Physical role functioning	56.25
Bodily pain	62.00
General health	57.00
Emotional role functioning	66.67
Vitality	50.00
Emotional well-being	60.00
Social functioning	60.00
Physical component summary (PCS)	46.25
Mental component summary (MCS)	44.52

21. Secondary Outcome

Title	PRO Scores: EQ5D-3L Questionnaire
Description	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)
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Analysis population: 303 EQ-5D-3L questionnaires were completed

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	303
EQ-5D-3L score	0.79
EQ_VAS score	69.00

22. Secondary Outcome

Title	PRO Scores: FACIT-Fatigue Questionnaire
Description	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).
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

Analysis population: 300 patients completed the FACIT-fatigue questionnaire

Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Measure Participants	300
Median (Inter-Quartile Range) [score on a scale]	39.00

23. Secondary Outcome

Title	Physician Medical Specialty
Description	Physician characteristics: medical specialty
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physician Population
Arm/Group Description	Physicians who recruited the patients with Giant Cell Arteritis (GCA)
Measure Participants	69
Internal Medicine	56 18.3%
Rheumatology	12 3.9%
Geriatry	1 0.3%

24. Secondary Outcome

Title	Physician Number of Years of Practice
Description	Number of years since medical school graduation
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physician Population
Arm/Group Description	Physicians who recruited the patients with Giant Cell Arteritis (GCA)
Measure Participants	69
Median (Inter-Quartile Range) [years]	13.00

25. Secondary Outcome

Title	Physician Type of Practice
Description	Physician main activity (University Hospital or General Services Hospital)
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physician Population
Arm/Group Description	Physicians who recruited the patients with Giant Cell Arteritis (GCA)
Measure Participants	69
University Hospital	39 12.7%
General Services Hospital	30 9.8%

26. Secondary Outcome

Title	Physician Characteristics: Number of GCA Diagnosis
Description	Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient
Time Frame	Baseline only

Outcome Measure Data

Analysis Population Description

1 physician for whom the data is missing

Arm/Group Title	Physician Population
Arm/Group Description	Physicians who recruited the patients with Giant Cell Arteritis (GCA)
Measure Participants	68
1 to 2 cases	2 0.7%
3 to 5 cases	17 5.6%
6 to 10 cases	12 3.9%
11 to 20 cases	16 5.2%
more than 20 cases	21 6.9%

Adverse Events

Adverse Event Reporting Description	This was a descriptive observational study on GCA characteristics and management in a real-life setting with no specific medicinal product to be investigated. No adverse events and reactions were collected.
Arm/Group Title	Patients Under Treatment(s) for GCA
Arm/Group Description	Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
All Cause Mortality
	Patients Under Treatment(s) for GCA
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Patients Under Treatment(s) for GCA
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Patients Under Treatment(s) for GCA
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.