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| Name | Class |
|---|---|
| ITEC Services | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients under treatment(s) for GCA | Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Journey : Physicians Who Referred the Patient | Proportion of patients for each physician specialty that referred the patient | Baseline only |
| Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA | Physician encountered by the patient at least one time since the first events related to GCA (Multiple answers possible, If a patient encountered a medical speciality more than one time, this speciality will be counted only once) | Baseline only |
| Patient Journey : Time to GCA Diagnosis | Time between GCA signs/symptoms and diagnosis | Baseline only |
| GCA Diagnostic Method | Proportions of each diagnostic method used | Baseline only |
| GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis | GCs treatment since diagnosis : Current GC dose at inclusion and total cumulative GC dose according to investigator (excl. IV bolus) since diagnosis. | Baseline only |
| GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion | Number of patients with at least one GC kinetic ongoing at inclusion | baseline only |
| GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Immunosuppressants for GCA taken since diagnosis and stopped before inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline only |
| Treatments in Patients With Comorbidities Related to GCs |
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Inclusion Criteria:
Non-inclusion Criteria:
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300 patients aged at least 50 years old, suffering from GCA, starting or under treatment for GCA recruited by 150 internists and rheumatologists practicing in hospitals or private clinics in Metropolitan France will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Alfred MAHR, Professor | alfred.mahr@aphp.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the Archet | Nice | Alpes-Maritimes | 06202 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Under Treatment(s) for GCA | Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA |
| FG001 | Physicians | Physicians who recruited the patients with Giant Cell Arteritis (GCA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Under Treatment(s) for GCA | Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA |
| BG001 | Physicians | Physicians who recruited the patients with Giant Cell Arteritis (GCA) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Physician age was not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Journey : Physicians Who Referred the Patient | Proportion of patients for each physician specialty that referred the patient | Posted | Count of Participants | Participants | Baseline only |
|
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Under Treatment(s) for GCA | Patients at least 50 years old with Giant Cell Arteritis (GCA) and under treatment(s) for GCA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Idier, Rheumatology Medical Leader | ChugaiPF | +33 (0) 1 56 37 44 89 | idier@chugai-pharm.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 17, 2018 | May 31, 2022 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 4, 2019 | May 31, 2022 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
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| Baseline only |
| GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Number of patients with at least one immunosuppressant ongoing at inclusion | Baseline only |
| GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion | Number of patients who have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion | Baseline only |
| GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Number of patients with at least one targeted biologic therapy ongoing at inclusion | Baseline only |
Number of patients with at least one ongoing treatment for comorbidities related to the use of GCs
| Baseline only |
| Proportion of Incident Patients | Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion | Baseline only |
| Proportion of Prevalent Patients | Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion | Baseline only |
| GCA Duration | Time since GCA diagnosis for overall population, prevalent and incident patients | Baseline only |
| GCA Initial Presentation | Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis | Baseline only |
| GCA Clinical Form | Proportion of patients with at least one relapse and number of relapses | Baseline only |
| Patients With GCA Complications | Proportions of patients with GCA complications | Baseline only |
| Global Arteritis Activity | Score of the physician and patient global arteritis activity on a 100 mm-visual analog scale (100mm-VAS) (Patients with physician's VAS score less than or equal to 10mm will be considered with "non-active GCA", while patients with physician's VAS score greater than 10 mm will be considered with "active GCA") | Baseline only |
| Patient Reported Outcome (PRO) Scores: Short Form-36 (SF-36) Questionnaire | Total and detailed scores of the self reported SF-36 questionnaire (36-Item Short Form Survey Instrument): 36 item survey measuring health-related quality-of-life. For each domains: score ranging from 0 (worst health status) to 100 (best health status) | Baseline only |
| PRO Scores: EQ5D-3L Questionnaire | Total score of the EuroQol-5 Dimensions 3 Levels (EQ5D-3L) questionnaire and perceived current health state (100mm-EQ_VAS score, 0 = 'Worst imaginable health state' and 100 = 'Best imaginable health state) | Baseline only |
| PRO Scores: FACIT-Fatigue Questionnaire | Total score of the 13-items Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) questionnaire. FACIT-Fatigue is an instrument that measures overall fatigue and its effects on the general functioning and daily activities through 13 questions. Each question has 5 levels: not at all, a little bit, somewhat, quite a bit, very much. Lower scores indicate greater fatigue. The total score of FACIT-Fatigue varies from 0 to 52 (score <30 = severe fatigue). | Baseline only |
| Physician Medical Specialty | Physician characteristics: medical specialty | Baseline only |
| Physician Number of Years of Practice | Number of years since medical school graduation | Baseline only |
| Physician Type of Practice | Physician main activity (University Hospital or General Services Hospital) | Baseline only |
| Physician Characteristics: Number of GCA Diagnosis | Number of GCA cases (Horton) personally treated within the last year prior to the date of inclusion of first patient | Baseline only |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Physician age was not collected | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Physician who follows the patient | This measure is not relevant for the physician population | Count of Participants | Participants |
|
| Patients' medical history | The most frequent SOCs (>10% of patients) of events occurring before GCA diagnosis | this measure is not relevant for the physician population | Count of Participants | Participants |
|
| Patients' comorbidities | The most frequent SOCs (>10% of patients) of events with ongoing specific treatments | This measure is not relevant for the physician population | Count of Participants | Participants |
|
| Treatments concomitant to diagnosis | Number of patients taking at least one of the following treatments at diagnosis | Analysis population for whom the data is not missing | Count of Participants | Participants |
|
| Treatments concomitant to inclusion | Number of patients taking at least one of the following treatments at inclusion | Analysis population for whom the data is not missing | Count of Participants | Participants |
|
|
| 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) | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Primary | Patient Journey : Time to GCA Diagnosis | Time between GCA signs/symptoms and diagnosis | Analysis population (missing data for 2 patients) | Posted | Median | Inter-Quartile Range | months | Baseline only |
|
|
|
| Primary | GCA Diagnostic Method | Proportions of each diagnostic method used | 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) | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | mg | Baseline only |
|
|
|
| Primary | GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion | Number of patients with at least one GC kinetic ongoing at inclusion | Posted | Count of Participants | Participants | baseline only |
|
|
|
| Primary | GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion | Immunosuppressants for GCA taken since diagnosis and stopped before inclusion | among analysis population, 27 patients have taken at least one immunosuppressant since diagnosis and stopped before inclusion | Posted | Number | number of treatments | Baseline only |
|
|
|
| Primary | GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion | Number of patients with at least one immunosuppressant ongoing at inclusion | Among analysis population, 35 Patient had at least one immunosuppressant ongoing at inclusion | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| 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 | Among analysis population, 8 patients have taken at least one targeted biologic therapy since diagnosis and stopped before inclusion | Posted | Number | treatments | Baseline only |
|
|
|
| Primary | GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion | Number of patients with at least one targeted biologic therapy ongoing at inclusion | Among analysis population, 45 patients had at least one targeted biologic therapy ongoing at inclusion | Posted | Number | treatments | Baseline only |
|
|
|
| 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) | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| 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 | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Secondary | Proportion of Incident Patients | Proportion of incident patients: patients with a diagnosis of GCA ≤ 6 weeks from inclusion | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Secondary | Proportion of Prevalent Patients | Proportion of prevalent patients: patients with a diagnosis of GCA > 6 weeks from inclusion | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Secondary | GCA Duration | Time since GCA diagnosis for overall population, prevalent and incident patients | Overall analysis population: N=306 / Prevalent patients (GCA diagnosis>6weeks), N=267 / Incident patients (GCA diagnosis ≤ 6weeks), N=39 | Posted | Median | Inter-Quartile Range | months | Baseline only |
|
|
|
| Secondary | GCA Initial Presentation | Proportions of patients with cranial GCA, Polymyalgia Rheumatica (PMR), extracranial GCA, elevated ESR/CRP and general signs at diagnosis | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Secondary | GCA Clinical Form | Proportion of patients with at least one relapse and number of relapses | Prevalent patients | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Secondary | Patients With GCA Complications | Proportions of patients with GCA complications | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| 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") | Posted | Median | Inter-Quartile Range | mm | Baseline only |
|
|
|
| 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) | Analysis population, SF-36 scores were missing for 11 patients | Posted | Median | Inter-Quartile Range | mm | Baseline only |
|
|
|
| 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) | Analysis population: 303 EQ-5D-3L questionnaires were completed | Posted | Median | Inter-Quartile Range | score on a scale | Baseline only |
|
|
|
| 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). | Analysis population: 300 patients completed the FACIT-fatigue questionnaire | Posted | Median | Inter-Quartile Range | score on a scale | Baseline only |
|
|
|
| Secondary | Physician Medical Specialty | Physician characteristics: medical specialty | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| Secondary | Physician Number of Years of Practice | Number of years since medical school graduation | Posted | Median | Inter-Quartile Range | years | Baseline only |
|
|
|
| Secondary | Physician Type of Practice | Physician main activity (University Hospital or General Services Hospital) | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| 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 | 1 physician for whom the data is missing | Posted | Count of Participants | Participants | Baseline only |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Geriatry |
|
| Title | Measurements |
|---|---|
|
| Emergency |
|
| Internist |
|
| Rheumatologist |
|
| Anatomical pathologist |
|
| Angiologist/Vascular surgeon |
|
| Cardiologist |
|
| Surgeon/Vascular surgeon |
|
| Endocrinologist/Diabetologist |
|
| Gastro-enterologist |
|
| Geriatrician |
|
| Ear, Nose, Throat specialist (ENT) |
|
| Pulmonologist |
|
| Radiologist |
|
| Other |
|
|
| Biopsy of the Temporal Artery (TAB) |
|
|
| High resolution color Doppler ultrasound |
|
|
| MRI of the temporal arteries |
|
|
| 18FDG PET |
|
|
| Aortic angio-CT |
|
|
| Title |
|---|
| Measurements |
|---|
|
| Leflunomide |
|
| Methotrexate |
|
| Mycophenolate Mofetil |
|
| Other |
|
| Title |
|---|
| Measurements |
|---|
|
| Leflunomide |
|
| Methotrexate |
|
| Mycophenolate Mofetil |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Infliximab |
|
| Tocilizumab |
|
| Other |
|
| Title |
|---|
| Measurements |
|---|
|
| Infliximab |
|
| Tocilizumab |
|
| Other |
|
| Gastrointestinal disorders |
|
| Hepatobiliary disorders |
|
| Infections and infestations |
|
| Injury, poisoning and procedural complications |
|
| Investigations |
|
| Metabolism and nutrition disorders |
|
| Musculoskeletal and connective tissue disorders |
|
| Nervous system disorders |
|
| Psychiatric disorders |
|
| Renal and urinary disorders |
|
| Respiratory, thoracic and mediastinal disorders |
|
| Surgical and medical procedures |
|
| Vascular disorders |
|
|
| Incident patients |
|
|
|
| Value of ESR (mm/1st h) > 50 mm/h |
|
| at least one general sign |
|
|
| Patients with 4 relapses |
|
| Patients with 5 relapses |
|
|
| Bodily pain |
|
|
| General health |
|
|
| Emotional role functioning |
|
|
| Vitality |
|
|
| Emotional well-being |
|
|
| Social functioning |
|
|
| Physical component summary (PCS) |
|
|
| Mental component summary (MCS) |
|
|
|
|
| 11 to 20 cases |
|
| more than 20 cases |
|