Giant Cell Arteritis
Conditions
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.
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.
Interventions
None listed
Sponsors
ITEC Services
Chugai Pharma France
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Baseline only | Immunosuppressants for GCA taken since diagnosis and stopped before inclusion |
| GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Baseline only | Number of patients with at least one immunosuppressant ongoing at inclusion |
| GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion | baseline only | Number of patients with at least one GC kinetic ongoing at inclusion |
| Patient Journey : Physicians Who Referred the Patient | 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 | 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 | Baseline only | Time between GCA signs/symptoms and diagnosis |
| GCA Diagnostic Method | Baseline only | Proportions of each diagnostic method used |
| 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. |
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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). |
| Physician Medical Specialty | Baseline only | Physician characteristics: medical specialty |
| 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) |
| Physician Type of Practice | Baseline only | Physician main activity (University Hospital or General Services Hospital) |
| 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 |
| Physician Number of Years of Practice | Baseline only | Number of years since medical school graduation |
| 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 |
| Proportion of Incident Patients | Baseline only | Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion |
| Proportion of Prevalent Patients | Baseline only | Proportion of prevalent patients: patients with a diagnosis of GCA \> 6 weeks from inclusion |
| GCA Duration | Baseline only | Time since GCA diagnosis for overall population, prevalent and incident patients |
| GCA Initial Presentation | Baseline only | Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis |
| GCA Clinical Form | Baseline only | Proportion of patients with at least one relapse and number of relapses |
| Patients With GCA Complications | Baseline only | Proportions of patients with GCA complications |
| 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) |
| 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) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Under Treatment(s) for GCA Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA | 306 |
| Physicians Physicians who recruited the patients with Giant Cell Arteritis (GCA) | 69 |
| Total | 375 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Patients Under Treatment(s) for GCA | Physicians |
|---|---|---|---|
| Age, Continuous | 73.98 years STANDARD_DEVIATION 7.88 | 73.98 years STANDARD_DEVIATION 7.88 | — |
| Age, Customized [50-70[ years | 84 Participants | 84 Participants | — |
| Age, Customized ≥ 70 years | 222 Participants | 222 Participants | — |
| Patients' comorbidities Cardiac disorders | 41 Participants | 41 Participants | — |
| Patients' comorbidities Metabolism and nutrition disorders | 79 Participants | 79 Participants | — |
| Patients' comorbidities Musculoskeletal and connective tissue disorders | 43 Participants | 43 Participants | — |
| Patients' comorbidities Psychiatric disorders | 37 Participants | 37 Participants | — |
| Patients' comorbidities Vascular disorders | 140 Participants | 140 Participants | — |
| Patients' medical history Cardiac disorders | 41 Participants | 41 Participants | — |
| Patients' medical history Eye disorders | 40 Participants | 40 Participants | — |
| Patients' medical history Metabolism and nutrition disorders | 73 Participants | 73 Participants | — |
| Patients' medical history Musculoskeletal and connective tissue disorders | 52 Participants | 52 Participants | — |
| Patients' medical history Psychiatric disorders | 31 Participants | 31 Participants | — |
| Patients' medical history Vascular disorders | 148 Participants | 148 Participants | — |
| Physician who follows the patient Geriatry | 2 Participants | 2 Participants | — |
| Physician who follows the patient Internal Medicine | 258 Participants | 258 Participants | — |
| Physician who follows the patient Rheumatologist | 46 Participants | 46 Participants | — |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 227 Participants | 206 Participants | 21 Participants |
| Sex: Female, Male Male | 148 Participants | 100 Participants | 48 Participants |
| Treatments concomitant to diagnosis Antidepressants | 22 Participants | 22 Participants | — |
| Treatments concomitant to diagnosis Antidiabetics | 25 Participants | 25 Participants | — |
| Treatments concomitant to diagnosis Antihypertensives | 141 Participants | 141 Participants | — |
| Treatments concomitant to diagnosis Antiosteoporotics | 26 Participants | 26 Participants | — |
| Treatments concomitant to diagnosis Antiplatelets | 68 Participants | 68 Participants | — |
| Treatments concomitant to diagnosis CA Vit D | 22 Participants | 22 Participants | — |
| Treatments concomitant to diagnosis Hypnotics | 29 Participants | 29 Participants | — |
| Treatments concomitant to diagnosis Inhibitors of the proton pump | 67 Participants | 67 Participants | — |
| Treatments concomitant to diagnosis Other | 53 Participants | 53 Participants | — |
| Treatments concomitant to diagnosis Statins | 40 Participants | 40 Participants | — |
| Treatments concomitant to inclusion Antidepressants | 31 Participants | 31 Participants | — |
| Treatments concomitant to inclusion Antidiabetics | 48 Participants | 48 Participants | — |
| Treatments concomitant to inclusion Antihypertensives | 152 Participants | 152 Participants | — |
| Treatments concomitant to inclusion Antiosteoporotics | 112 Participants | 112 Participants | — |
| Treatments concomitant to inclusion Antiplatelets | 158 Participants | 158 Participants | — |
| Treatments concomitant to inclusion CA Vit D | 70 Participants | 70 Participants | — |
| Treatments concomitant to inclusion Hypnotics | 35 Participants | 35 Participants | — |
| Treatments concomitant to inclusion Inhibitors of the proton pump | 130 Participants | 130 Participants | — |
| Treatments concomitant to inclusion Other | 79 Participants | 79 Participants | — |
| Treatments concomitant to inclusion Statins | 64 Participants | 64 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
GCA Diagnostic Method
Proportions of each diagnostic method used
Time frame: 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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | Erythrocyte Sedimentation Rate (ESR | 154 Participants |
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | C-Reactive Protein (CRP) | 266 Participants |
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | Biopsy of the Temporal Artery (TAB) | 249 Participants |
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | High resolution color Doppler ultrasound | 91 Participants |
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | MRI of the temporal arteries | 20 Participants |
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | 18FDG PET | 74 Participants |
| Patients Under Treatment(s) for GCA | GCA Diagnostic Method | Aortic angio-CT | 87 Participants |
Primary
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion
Number of patients with at least one GC kinetic ongoing at inclusion
Time frame: baseline only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion | 273 Participants |
Primary
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.
Time frame: Baseline only
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis | Current dose at inclusion | 9.00 mg |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis | Total cumulative dose | 4305.00 mg |
Primary
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion
Number of patients with at least one immunosuppressant ongoing at inclusion
Time frame: Baseline only
Population: Among analysis population, 35 Patient had at least one immunosuppressant ongoing at inclusion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Azathioprine | 0 Participants |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Cyclophosphamide | 0 Participants |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Cyclosporine | 0 Participants |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Leflunomide | 0 Participants |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Methotrexate | 35 Participants |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Mycophenolate Mofetil | 0 Participants |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Other | 0 Participants |
Primary
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion
Immunosuppressants for GCA taken since diagnosis and stopped before inclusion
Time frame: Baseline only
Population: among analysis population, 27 patients have taken at least one immunosuppressant since diagnosis and stopped before inclusion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Azathioprine | 2 number of treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Cyclophosphamide | 1 number of treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Cyclosporine | 0 number of treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Leflunomide | 1 number of treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Methotrexate | 25 number of treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Mycophenolate Mofetil | 0 number of treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Other | 0 number of treatments |
Primary
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion
Number of patients with at least one targeted biologic therapy ongoing at inclusion
Time frame: Baseline only
Population: Among analysis population, 45 patients had at least one targeted biologic therapy ongoing at inclusion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Adalimumab | 0 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Abatacept | 0 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Etanercept | 0 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Infliximab | 1 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Tocilizumab | 44 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Other | 0 treatments |
Primary
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
Time frame: Baseline only
Population: Among analysis population, 8 patients have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Adalimumab | 1 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Abatacept | 0 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Etanercept | 0 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Infliximab | 0 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Tocilizumab | 9 treatments |
| Patients Under Treatment(s) for GCA | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Other | 0 treatments |
Primary
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)
Time frame: Baseline only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients 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 |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Ophthalmologist | 88 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Neurologist | 38 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Emergency | 54 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Internist | 59 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Rheumatologist | 42 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Anatomical pathologist | 3 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Angiologist/Vascular surgeon | 17 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Cardiologist | 20 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Surgeon/Vascular surgeon | 9 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Endocrinologist/Diabetologist | 3 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Gastro-enterologist | 6 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Geriatrician | 3 Participants |
| Patients Under Treatment(s) for GCA | 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 |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Pulmonologist | 5 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Radiologist | 7 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Other | 30 Participants |
Primary
Patient Journey : Physicians Who Referred the Patient
Proportion of patients for each physician specialty that referred the patient
Time frame: Baseline only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | General Practitioner | 171 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Ophthalmologist | 31 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Neurologist | 21 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Emergency | 17 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Internist | 13 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Rheumatologist | 15 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Other | 12 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Anatomical Pathologist | 0 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Angiologist/Vascular doctor | 7 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Cardiologist | 10 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Surgeon/Vascular surgeon | 3 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Endocrinologist/Diabetologist | 1 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Gastro-enterologist | 0 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Geriatrician | 3 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Ear, Nose and Throat specialist (ENT) | 0 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Pulmonologist | 1 Participants |
| Patients Under Treatment(s) for GCA | Patient Journey : Physicians Who Referred the Patient | Radiologist | 1 Participants |
Primary
Patient Journey : Time to GCA Diagnosis
Time between GCA signs/symptoms and diagnosis
Time frame: Baseline only
Population: Analysis population (missing data for 2 patients)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Under Treatment(s) for GCA | Patient Journey : Time to GCA Diagnosis | 1.00 months |
Secondary
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)
Time frame: Baseline only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Cardiac disorders | 5 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Endocrine disorders | 2 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Eye disorders | 9 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Gastrointestinal disorders | 4 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Hepatobiliary disorders | 2 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Infections and infestations | 10 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Injury, poisoning and procedural complications | 7 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Investigations | 4 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Metabolism and nutrition disorders | 44 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Musculoskeletal and connective tissue disorders | 25 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Nervous system disorders | 7 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Psychiatric disorders | 18 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Renal and urinary disorders | 2 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Respiratory, thoracic and mediastinal disorders | 3 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Surgical and medical procedures | 4 Participants |
| Patients Under Treatment(s) for GCA | Comorbidities Related to GCs | Vascular disorders | 33 Participants |
Secondary
GCA Clinical Form
Proportion of patients with at least one relapse and number of relapses
Time frame: Baseline only
Population: Prevalent patients
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Clinical Form | Patients with 3 relapses | 11 Participants |
| Patients Under Treatment(s) for GCA | GCA Clinical Form | Patients with 4 relapses | 6 Participants |
| Patients Under Treatment(s) for GCA | GCA Clinical Form | Patients with 5 relapses | 4 Participants |
| Patients Under Treatment(s) for GCA | GCA Clinical Form | Patients with 1 relapse | 69 Participants |
| Patients Under Treatment(s) for GCA | GCA Clinical Form | Patients with 2 relapses | 32 Participants |
Secondary
GCA Duration
Time since GCA diagnosis for overall population, prevalent and incident patients
Time frame: Baseline only
Population: Overall analysis population: N=306 / Prevalent patients (GCA diagnosis\>6weeks), N=267 / Incident patients (GCA diagnosis ≤ 6weeks), N=39
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Duration | Overall population | 13.00 months |
| Patients Under Treatment(s) for GCA | GCA Duration | Prevalent patients | 15.00 months |
| Patients Under Treatment(s) for GCA | GCA Duration | Incident patients | 0.60 months |
Secondary
GCA Initial Presentation
Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis
Time frame: Baseline only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | GCA Initial Presentation | at least one cranial manifestation | 271 Participants |
| Patients Under Treatment(s) for GCA | GCA Initial Presentation | at least one PMR symptom | 148 Participants |
| Patients Under Treatment(s) for GCA | GCA Initial Presentation | at least one extracranial event (excl. PMR) | 108 Participants |
| Patients Under Treatment(s) for GCA | GCA Initial Presentation | Value of ESR (mm/1st h) > 50 mm/h | 129 Participants |
| Patients Under Treatment(s) for GCA | GCA Initial Presentation | at least one general sign | 227 Participants |
Secondary
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)
Time frame: Baseline only
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Global Arteritis Activity | Patient VAS score | 18.00 mm |
| Patients Under Treatment(s) for GCA | Global Arteritis Activity | Physician VAS score | 4.00 mm |
Secondary
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)
Time frame: Baseline only
Population: Analysis population, SF-36 scores were missing for 11 patients
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Physical functioning | 70.00 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Physical role functioning | 56.25 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Bodily pain | 62.00 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | General health | 57.00 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Emotional role functioning | 66.67 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Vitality | 50.00 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Emotional well-being | 60.00 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Social functioning | 60.00 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Physical component summary (PCS) | 46.25 mm |
| Patients Under Treatment(s) for GCA | Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Mental component summary (MCS) | 44.52 mm |
Secondary
Patients With GCA Complications
Proportions of patients with GCA complications
Time frame: Baseline only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Under Treatment(s) for GCA | Patients With GCA Complications | 48 Participants |
Secondary
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
Time frame: Baseline only
Population: 1 physician for whom the data is missing
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Physician Characteristics: Number of GCA Diagnosis | 1 to 2 cases | 2 Participants |
| Patients Under Treatment(s) for GCA | Physician Characteristics: Number of GCA Diagnosis | 3 to 5 cases | 17 Participants |
| Patients Under Treatment(s) for GCA | Physician Characteristics: Number of GCA Diagnosis | 6 to 10 cases | 12 Participants |
| Patients Under Treatment(s) for GCA | Physician Characteristics: Number of GCA Diagnosis | 11 to 20 cases | 16 Participants |
| Patients Under Treatment(s) for GCA | Physician Characteristics: Number of GCA Diagnosis | more than 20 cases | 21 Participants |
Secondary
Physician Medical Specialty
Physician characteristics: medical specialty
Time frame: Baseline only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Physician Medical Specialty | Internal Medicine | 56 Participants |
| Patients Under Treatment(s) for GCA | Physician Medical Specialty | Rheumatology | 12 Participants |
| Patients Under Treatment(s) for GCA | Physician Medical Specialty | Geriatry | 1 Participants |
Secondary
Physician Number of Years of Practice
Number of years since medical school graduation
Time frame: Baseline only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Under Treatment(s) for GCA | Physician Number of Years of Practice | 13.00 years |
Secondary
Physician Type of Practice
Physician main activity (University Hospital or General Services Hospital)
Time frame: Baseline only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | Physician Type of Practice | University Hospital | 39 Participants |
| Patients Under Treatment(s) for GCA | Physician Type of Practice | General Services Hospital | 30 Participants |
Secondary
Proportion of Incident Patients
Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion
Time frame: Baseline only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Under Treatment(s) for GCA | Proportion of Incident Patients | 39 Participants |
Secondary
Proportion of Prevalent Patients
Proportion of prevalent patients: patients with a diagnosis of GCA \> 6 weeks from inclusion
Time frame: Baseline only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Under Treatment(s) for GCA | Proportion of Prevalent Patients | 267 Participants |
Secondary
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)
Time frame: Baseline only
Population: Analysis population: 303 EQ-5D-3L questionnaires were completed
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Patients Under Treatment(s) for GCA | PRO Scores: EQ5D-3L Questionnaire | EQ-5D-3L score | 0.79 score on a scale |
| Patients Under Treatment(s) for GCA | PRO Scores: EQ5D-3L Questionnaire | EQ_VAS score | 69.00 score on a scale |
Secondary
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).
Time frame: Baseline only
Population: Analysis population: 300 patients completed the FACIT-fatigue questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Under Treatment(s) for GCA | PRO Scores: FACIT-Fatigue Questionnaire | 39.00 score on a scale |
Secondary
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
Time frame: Baseline only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Under Treatment(s) for GCA | Treatments in Patients With Comorbidities Related to GCs | 98 Participants |