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NCT03658889: ARTEMIS

Assessment of Giant Cell Arteritis Medical Practices in France

Completed Results posted Last updated 22 July 2022
What this trial tests

trial in Giant Cell Arteritis in 306 participants. Completed in 9 November 2018.

Timeline
2 August 2018
Primary endpoint
9 November 2018
9 November 2018

Quick facts

Lead sponsorChugai Pharma France
StatusCompleted
Study typeOBSERVATIONAL
Enrollment306
Start date2 August 2018
Primary completion9 November 2018
Estimated completion9 November 2018
Sites1 location across France

Conditions studied

Sponsor

Chugai Pharma France

Who can join

50 and older, any sex, with Giant Cell Arteritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Journey : Physicians Who Referred the Patient Primary · Baseline only

Proportion of patients for each physician specialty that referred the patient

General Practitioner
GroupValue95% CI
Patients Under Treatment(s) for GCA171
Ophthalmologist
GroupValue95% CI
Patients Under Treatment(s) for GCA31
Neurologist
GroupValue95% CI
Patients Under Treatment(s) for GCA21
Emergency
GroupValue95% CI
Patients Under Treatment(s) for GCA17
Internist
GroupValue95% CI
Patients Under Treatment(s) for GCA13
Rheumatologist
GroupValue95% CI
Patients Under Treatment(s) for GCA15
Other
GroupValue95% CI
Patients Under Treatment(s) for GCA12
Anatomical Pathologist
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Patient Journey : Physician Encountered by the Patient at Least One Time Since the First Events Related to GCA Primary · 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)

General Practitioner
GroupValue95% CI
Patients Under Treatment(s) for GCA260
Ophthalmologist
GroupValue95% CI
Patients Under Treatment(s) for GCA88
Neurologist
GroupValue95% CI
Patients Under Treatment(s) for GCA38
Emergency
GroupValue95% CI
Patients Under Treatment(s) for GCA54
Internist
GroupValue95% CI
Patients Under Treatment(s) for GCA59
Rheumatologist
GroupValue95% CI
Patients Under Treatment(s) for GCA42
Anatomical pathologist
GroupValue95% CI
Patients Under Treatment(s) for GCA3
Angiologist/Vascular surgeon
GroupValue95% CI
Patients Under Treatment(s) for GCA17
Patient Journey : Time to GCA Diagnosis Primary · Baseline only

Time between GCA signs/symptoms and diagnosis

GroupValue95% CI
Patients Under Treatment(s) for GCA1.001.00 – 3.00
GCA Diagnostic Method Primary · Baseline only

Proportions of each diagnostic method used

Erythrocyte Sedimentation Rate (ESR
GroupValue95% CI
Patients Under Treatment(s) for GCA154
C-Reactive Protein (CRP)
GroupValue95% CI
Patients Under Treatment(s) for GCA266
Biopsy of the Temporal Artery (TAB)
GroupValue95% CI
Patients Under Treatment(s) for GCA249
High resolution color Doppler ultrasound
GroupValue95% CI
Patients Under Treatment(s) for GCA91
MRI of the temporal arteries
GroupValue95% CI
Patients Under Treatment(s) for GCA20
18FDG PET
GroupValue95% CI
Patients Under Treatment(s) for GCA74
Aortic angio-CT
GroupValue95% CI
Patients Under Treatment(s) for GCA87
GCA Treatments Since Diagnosis : Glucocorticoids Since Diagnosis Primary · Baseline only

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

Current dose at inclusion
GroupValue95% CI
Patients Under Treatment(s) for GCA9.005.00 – 20.00
Total cumulative dose
GroupValue95% CI
Patients Under Treatment(s) for GCA4305.001920.00 – 7000.00
GCA Treatments Since Diagnosis: Glucocorticoids at Inclusion Primary · baseline only

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

GroupValue95% CI
Patients Under Treatment(s) for GCA273
GCA Treatments Since Diagnosis: Immunosuppressants Stopped Before Inclusion Primary · Baseline only

Immunosuppressants for GCA taken since diagnosis and stopped before inclusion

Azathioprine
GroupValue95% CI
Patients Under Treatment(s) for GCA2
Cyclophosphamide
GroupValue95% CI
Patients Under Treatment(s) for GCA1
Cyclosporine
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Leflunomide
GroupValue95% CI
Patients Under Treatment(s) for GCA1
Methotrexate
GroupValue95% CI
Patients Under Treatment(s) for GCA25
Mycophenolate Mofetil
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Other
GroupValue95% CI
Patients Under Treatment(s) for GCA0
GCA Treatments Since Diagnosis: Immunosuppressants Ongoing at Inclusion Primary · Baseline only

Number of patients with at least one immunosuppressant ongoing at inclusion

Azathioprine
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Cyclophosphamide
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Cyclosporine
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Leflunomide
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Methotrexate
GroupValue95% CI
Patients Under Treatment(s) for GCA35
Mycophenolate Mofetil
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Other
GroupValue95% CI
Patients Under Treatment(s) for GCA0
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Stopped Before Inclusion Primary · Baseline only

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

Adalimumab
GroupValue95% CI
Patients Under Treatment(s) for GCA1
Abatacept
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Etanercept
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Infliximab
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Tocilizumab
GroupValue95% CI
Patients Under Treatment(s) for GCA9
Other
GroupValue95% CI
Patients Under Treatment(s) for GCA0
GCA Treatments Since Diagnosis: Targeted Biologic Therapies Ongoing at Inclusion Primary · Baseline only

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

Adalimumab
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Abatacept
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Etanercept
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Infliximab
GroupValue95% CI
Patients Under Treatment(s) for GCA1
Tocilizumab
GroupValue95% CI
Patients Under Treatment(s) for GCA44
Other
GroupValue95% CI
Patients Under Treatment(s) for GCA0
Comorbidities Related to GCs Secondary · Baseline only

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

Cardiac disorders
GroupValue95% CI
Patients Under Treatment(s) for GCA5
Endocrine disorders
GroupValue95% CI
Patients Under Treatment(s) for GCA2
Eye disorders
GroupValue95% CI
Patients Under Treatment(s) for GCA9
Gastrointestinal disorders
GroupValue95% CI
Patients Under Treatment(s) for GCA4
Hepatobiliary disorders
GroupValue95% CI
Patients Under Treatment(s) for GCA2
Infections and infestations
GroupValue95% CI
Patients Under Treatment(s) for GCA10
Injury, poisoning and procedural complications
GroupValue95% CI
Patients Under Treatment(s) for GCA7
Investigations
GroupValue95% CI
Patients Under Treatment(s) for GCA4
Treatments in Patients With Comorbidities Related to GCs Secondary · Baseline only

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

GroupValue95% CI
Patients Under Treatment(s) for GCA98

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Presentation and Real-World Management of Giant Cell Arteritis (Artemis Study).
    Mahr A, Hachulla E, de Boysson H, Guerroui N, et al · · 2021 · cited 17× · PMID 34859001 · DOI 10.3389/fmed.2021.732934

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing