Trial Outcomes & Findings for Assessment of Giant Cell Arteritis Medical Practices in France (NCT NCT03658889)

NCT ID: NCT03658889

Last Updated: 2022-07-22

Results Overview

Proportion of patients for each physician specialty that referred the patient

• Recruitment status: COMPLETED
• Target enrollment: 306 participants
• Primary outcome timeframe: Baseline only
• Results posted on: 2022-07-22

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Patients Under Treatment(s) for GCA Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA	Physicians Physicians who recruited the patients with Giant Cell Arteritis (GCA)
Overall Study Protocol Violation	2	0

Baseline Characteristics

Physician age was not collected

Baseline characteristics by cohort

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA	Physicians n=69 Participants Physicians who recruited the patients with Giant Cell Arteritis (GCA)	Total n=375 Participants Total of all reporting groups
Age, Continuous	73.98 years STANDARD_DEVIATION 7.88 • n=306 Participants • Physician age was not collected	—	73.98 years STANDARD_DEVIATION 7.88 • n=306 Participants • Physician age was not collected
Age, Customized [50-70[ years	84 Participants n=306 Participants • Physician age was not collected	—	84 Participants n=306 Participants • Physician age was not collected
Age, Customized ≥ 70 years	222 Participants n=306 Participants • Physician age was not collected	—	222 Participants n=306 Participants • Physician age was not collected
Sex: Female, Male Female	206 Participants n=306 Participants	21 Participants n=69 Participants	227 Participants n=375 Participants
Sex: Female, Male Male	100 Participants n=306 Participants	48 Participants n=69 Participants	148 Participants n=375 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Physician who follows the patient Internal Medicine	258 Participants n=306 Participants • This measure is not relevant for the physician population	—	258 Participants n=306 Participants • This measure is not relevant for the physician population
Physician who follows the patient Rheumatologist	46 Participants n=306 Participants • This measure is not relevant for the physician population	—	46 Participants n=306 Participants • This measure is not relevant for the physician population
Physician who follows the patient Geriatry	2 Participants n=306 Participants • This measure is not relevant for the physician population	—	2 Participants n=306 Participants • This measure is not relevant for the physician population
Patients' medical history Vascular disorders	148 Participants n=306 Participants • this measure is not relevant for the physician population	—	148 Participants n=306 Participants • this measure is not relevant for the physician population
Patients' medical history Metabolism and nutrition disorders	73 Participants n=306 Participants • this measure is not relevant for the physician population	—	73 Participants n=306 Participants • this measure is not relevant for the physician population
Patients' medical history Musculoskeletal and connective tissue disorders	52 Participants n=306 Participants • this measure is not relevant for the physician population	—	52 Participants n=306 Participants • this measure is not relevant for the physician population
Patients' medical history Cardiac disorders	41 Participants n=306 Participants • this measure is not relevant for the physician population	—	41 Participants n=306 Participants • this measure is not relevant for the physician population
Patients' medical history Eye disorders	40 Participants n=306 Participants • this measure is not relevant for the physician population	—	40 Participants n=306 Participants • this measure is not relevant for the physician population
Patients' medical history Psychiatric disorders	31 Participants n=306 Participants • this measure is not relevant for the physician population	—	31 Participants n=306 Participants • this measure is not relevant for the physician population
Patients' comorbidities Vascular disorders	140 Participants n=306 Participants • This measure is not relevant for the physician population	—	140 Participants n=306 Participants • This measure is not relevant for the physician population
Patients' comorbidities Metabolism and nutrition disorders	79 Participants n=306 Participants • This measure is not relevant for the physician population	—	79 Participants n=306 Participants • This measure is not relevant for the physician population
Patients' comorbidities Musculoskeletal and connective tissue disorders	43 Participants n=306 Participants • This measure is not relevant for the physician population	—	43 Participants n=306 Participants • This measure is not relevant for the physician population
Patients' comorbidities Cardiac disorders	41 Participants n=306 Participants • This measure is not relevant for the physician population	—	41 Participants n=306 Participants • This measure is not relevant for the physician population
Patients' comorbidities Psychiatric disorders	37 Participants n=306 Participants • This measure is not relevant for the physician population	—	37 Participants n=306 Participants • This measure is not relevant for the physician population
Treatments concomitant to diagnosis Antiplatelets	68 Participants n=304 Participants • Analysis population for whom the data is not missing	—	68 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Statins	40 Participants n=305 Participants • Analysis population for whom the data is not missing	—	40 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Antiosteoporotics	26 Participants n=304 Participants • Analysis population for whom the data is not missing	—	26 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Antihypertensives	141 Participants n=305 Participants • Analysis population for whom the data is not missing	—	141 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Antidiabetics	25 Participants n=304 Participants • Analysis population for whom the data is not missing	—	25 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Inhibitors of the proton pump	67 Participants n=305 Participants • Analysis population for whom the data is not missing	—	67 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Hypnotics	29 Participants n=305 Participants • Analysis population for whom the data is not missing	—	29 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Antidepressants	22 Participants n=306 Participants • Analysis population for whom the data is not missing	—	22 Participants n=306 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis CA Vit D	22 Participants n=306 Participants • Analysis population for whom the data is not missing	—	22 Participants n=306 Participants • Analysis population for whom the data is not missing
Treatments concomitant to diagnosis Other	53 Participants n=305 Participants • Analysis population for whom the data is not missing	—	53 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Antiplatelets	158 Participants n=305 Participants • Analysis population for whom the data is not missing	—	158 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Statins	64 Participants n=304 Participants • Analysis population for whom the data is not missing	—	64 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Antiosteoporotics	112 Participants n=304 Participants • Analysis population for whom the data is not missing	—	112 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Antihypertensives	152 Participants n=304 Participants • Analysis population for whom the data is not missing	—	152 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Antidiabetics	48 Participants n=304 Participants • Analysis population for whom the data is not missing	—	48 Participants n=304 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Inhibitors of the proton pump	130 Participants n=305 Participants • Analysis population for whom the data is not missing	—	130 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Hypnotics	35 Participants n=305 Participants • Analysis population for whom the data is not missing	—	35 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Antidepressants	31 Participants n=305 Participants • Analysis population for whom the data is not missing	—	31 Participants n=305 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion CA Vit D	70 Participants n=306 Participants • Analysis population for whom the data is not missing	—	70 Participants n=306 Participants • Analysis population for whom the data is not missing
Treatments concomitant to inclusion Other	79 Participants n=305 Participants • Analysis population for whom the data is not missing	—	79 Participants n=305 Participants • Analysis population for whom the data is not missing

PRIMARY outcome

Timeframe: Baseline only

Proportion of patients for each physician specialty that referred the patient

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Patient Journey : Physicians Who Referred the Patient Radiologist	1 Participants
Patient Journey : Physicians Who Referred the Patient General Practitioner	171 Participants
Patient Journey : Physicians Who Referred the Patient Ophthalmologist	31 Participants
Patient Journey : Physicians Who Referred the Patient Neurologist	21 Participants
Patient Journey : Physicians Who Referred the Patient Emergency	17 Participants
Patient Journey : Physicians Who Referred the Patient Internist	13 Participants
Patient Journey : Physicians Who Referred the Patient Rheumatologist	15 Participants
Patient Journey : Physicians Who Referred the Patient Other	12 Participants
Patient Journey : Physicians Who Referred the Patient Anatomical Pathologist	0 Participants
Patient Journey : Physicians Who Referred the Patient Angiologist/Vascular doctor	7 Participants
Patient Journey : Physicians Who Referred the Patient Cardiologist	10 Participants
Patient Journey : Physicians Who Referred the Patient Surgeon/Vascular surgeon	3 Participants
Patient Journey : Physicians Who Referred the Patient Endocrinologist/Diabetologist	1 Participants
Patient Journey : Physicians Who Referred the Patient Gastro-enterologist	0 Participants
Patient Journey : Physicians Who Referred the Patient Geriatrician	3 Participants
Patient Journey : Physicians Who Referred the Patient Ear, Nose and Throat specialist (ENT)	0 Participants
Patient Journey : Physicians Who Referred the Patient Pulmonologist	1 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA General Practitioner	260 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Ophthalmologist	88 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Neurologist	38 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Emergency	54 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Internist	59 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Rheumatologist	42 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Anatomical pathologist	3 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Angiologist/Vascular surgeon	17 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Cardiologist	20 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Surgeon/Vascular surgeon	9 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Endocrinologist/Diabetologist	3 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Gastro-enterologist	6 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Geriatrician	3 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Ear, Nose, Throat specialist (ENT)	9 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Pulmonologist	5 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Radiologist	7 Participants
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Other	30 Participants

PRIMARY outcome

Timeframe: Baseline only

Population: Analysis population (missing data for 2 patients)

Time between GCA signs/symptoms and diagnosis

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=304 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Patient Journey : Time to GCA Diagnosis	1.00 months Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: Baseline only

Population: 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)

Proportions of each diagnostic method used

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Diagnostic Method Erythrocyte Sedimentation Rate (ESR	154 Participants
GCA Diagnostic Method C-Reactive Protein (CRP)	266 Participants
GCA Diagnostic Method Biopsy of the Temporal Artery (TAB)	249 Participants
GCA Diagnostic Method High resolution color Doppler ultrasound	91 Participants
GCA Diagnostic Method MRI of the temporal arteries	20 Participants
GCA Diagnostic Method 18FDG PET	74 Participants
GCA Diagnostic Method Aortic angio-CT	87 Participants

PRIMARY outcome

Timeframe: Baseline only

GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis.

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis Current dose at inclusion	9.00 mg Interval 5.0 to 20.0
GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis Total cumulative dose	4305.00 mg Interval 1920.0 to 7000.0

PRIMARY outcome

Timeframe: baseline only

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion	273 Participants

PRIMARY outcome

Timeframe: Baseline only

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

Immunosuppressants for GCA taken since diagnosis and stopped before inclusion

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=27 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Azathioprine	2 number of treatments
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Cyclophosphamide	1 number of treatments
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Cyclosporine	0 number of treatments
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Leflunomide	1 number of treatments
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Methotrexate	25 number of treatments
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Mycophenolate Mofetil	0 number of treatments
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Other	0 number of treatments

PRIMARY outcome

Timeframe: Baseline only

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

Number of patients with at least one immunosuppressant ongoing at inclusion

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=35 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Azathioprine	0 Participants
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Cyclophosphamide	0 Participants
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Cyclosporine	0 Participants
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Leflunomide	0 Participants
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Methotrexate	35 Participants
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Mycophenolate Mofetil	0 Participants
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Other	0 Participants

PRIMARY outcome

Timeframe: Baseline only

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

Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=8 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Adalimumab	1 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Abatacept	0 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Etanercept	0 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Infliximab	0 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Tocilizumab	9 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Other	0 treatments

PRIMARY outcome

Timeframe: Baseline only

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

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=45 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Adalimumab	0 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Abatacept	0 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Etanercept	0 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Infliximab	1 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Tocilizumab	44 treatments
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Other	0 treatments

SECONDARY outcome

Timeframe: Baseline only

Comorbidities related/ aggravated by the use of GCs according to the investigator's judgment in at least 2 patients (by SOC)

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Comorbidities Related to GCs Nervous system disorders	7 Participants
Comorbidities Related to GCs Cardiac disorders	5 Participants
Comorbidities Related to GCs Endocrine disorders	2 Participants
Comorbidities Related to GCs Eye disorders	9 Participants
Comorbidities Related to GCs Gastrointestinal disorders	4 Participants
Comorbidities Related to GCs Hepatobiliary disorders	2 Participants
Comorbidities Related to GCs Infections and infestations	10 Participants
Comorbidities Related to GCs Injury, poisoning and procedural complications	7 Participants
Comorbidities Related to GCs Investigations	4 Participants
Comorbidities Related to GCs Metabolism and nutrition disorders	44 Participants
Comorbidities Related to GCs Musculoskeletal and connective tissue disorders	25 Participants
Comorbidities Related to GCs Psychiatric disorders	18 Participants
Comorbidities Related to GCs Renal and urinary disorders	2 Participants
Comorbidities Related to GCs Respiratory, thoracic and mediastinal disorders	3 Participants
Comorbidities Related to GCs Surgical and medical procedures	4 Participants
Comorbidities Related to GCs Vascular disorders	33 Participants

SECONDARY outcome

Timeframe: Baseline only

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Treatments in Patients With Comorbidities Related to GCs	98 Participants

SECONDARY outcome

Timeframe: Baseline only

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Proportion of Incident Patients	39 Participants

SECONDARY outcome

Timeframe: Baseline only

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Proportion of Prevalent Patients	267 Participants

SECONDARY outcome

Timeframe: Baseline only

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

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Duration Overall population	13.00 months Interval 5.0 to 26.0
GCA Duration Prevalent patients	15.00 months Interval 7.0 to 30.0
GCA Duration Incident patients	0.60 months Interval 0.2 to 1.0

SECONDARY outcome

Timeframe: Baseline only

Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Initial Presentation at least one cranial manifestation	271 Participants
GCA Initial Presentation at least one PMR symptom	148 Participants
GCA Initial Presentation at least one extracranial event (excl. PMR)	108 Participants
GCA Initial Presentation Value of ESR (mm/1st h) > 50 mm/h	129 Participants
GCA Initial Presentation at least one general sign	227 Participants

SECONDARY outcome

Timeframe: Baseline only

Population: Prevalent patients

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=267 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
GCA Clinical Form Patients with 1 relapse	69 Participants
GCA Clinical Form Patients with 2 relapses	32 Participants
GCA Clinical Form Patients with 3 relapses	11 Participants
GCA Clinical Form Patients with 4 relapses	6 Participants
GCA Clinical Form Patients with 5 relapses	4 Participants

SECONDARY outcome

Timeframe: Baseline only

Proportions of patients with GCA complications

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Patients With GCA Complications	48 Participants

SECONDARY outcome

Timeframe: 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")

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=306 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Global Arteritis Activity Patient VAS score	18.00 mm Interval 5.0 to 47.0
Global Arteritis Activity Physician VAS score	4.00 mm Interval 1.0 to 14.0

SECONDARY outcome

Timeframe: Baseline only

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

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)

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=295 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Physical functioning	70.00 mm Interval 45.0 to 90.0
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Physical role functioning	56.25 mm Interval 31.25 to 87.5
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Bodily pain	62.00 mm Interval 31.25 to 87.5
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire General health	57.00 mm Interval 42.0 to 72.0
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Emotional role functioning	66.67 mm Interval 41.67 to 91.67
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Vitality	50.00 mm Interval 31.25 to 68.75
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Emotional well-being	60.00 mm Interval 45.0 to 80.0
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Social functioning	60.00 mm Interval 45.0 to 80.0
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Physical component summary (PCS)	46.25 mm Interval 38.35 to 52.81
Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire Mental component summary (MCS)	44.52 mm Interval 34.43 to 53.06

SECONDARY outcome

Timeframe: Baseline only

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

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)

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=303 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
PRO Scores: EQ5D-3L Questionnaire EQ-5D-3L score	0.79 score on a scale Interval 0.56 to 0.87
PRO Scores: EQ5D-3L Questionnaire EQ_VAS score	69.00 score on a scale Interval 50.0 to 80.0

SECONDARY outcome

Timeframe: Baseline only

Population: Analysis population: 300 patients completed the 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).

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=300 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
PRO Scores: FACIT-Fatigue Questionnaire	39.00 score on a scale Interval 28.0 to 46.0

SECONDARY outcome

Timeframe: Baseline only

Physician characteristics: medical specialty

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=69 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Physician Medical Specialty Internal Medicine	56 Participants
Physician Medical Specialty Rheumatology	12 Participants
Physician Medical Specialty Geriatry	1 Participants

SECONDARY outcome

Timeframe: Baseline only

Number of years since medical school graduation

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=69 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Physician Number of Years of Practice	13.00 years Interval 6.0 to 20.0

SECONDARY outcome

Timeframe: Baseline only

Physician main activity (University Hospital or General Services Hospital)

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=69 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Physician Type of Practice University Hospital	39 Participants
Physician Type of Practice General Services Hospital	30 Participants

SECONDARY outcome

Timeframe: Baseline only

Population: 1 physician for whom the data is missing

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

Outcome measures

Measure	Patients Under Treatment(s) for GCA n=68 Participants Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA
Physician Characteristics: Number of GCA Diagnosis 1 to 2 cases	2 Participants
Physician Characteristics: Number of GCA Diagnosis 3 to 5 cases	17 Participants
Physician Characteristics: Number of GCA Diagnosis 6 to 10 cases	12 Participants
Physician Characteristics: Number of GCA Diagnosis 11 to 20 cases	16 Participants
Physician Characteristics: Number of GCA Diagnosis more than 20 cases	21 Participants

Adverse Events

Patients Under Treatment(s) for GCA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Isabelle Idier, Rheumatology Medical Leader

ChugaiPF

Phone: +33 (0) 1 56 37 44 89

Email: idier@chugai-pharm.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place