Assessment of Giant Cell Arteritis Medical Practices in France

NCT03658889 | Completed Results

• 1 other identifier: CPF_ARTEMIS2018
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (10)

• 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

  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

Secondary Outcomes (16)

• Comorbidities Related to GCs

  Baseline only

• Treatments in Patients With Comorbidities Related to GCs

  Baseline only

• Proportion of Incident Patients

  Baseline only

• Proportion of Prevalent Patients

  Baseline only

• GCA Duration

  Baseline only

Study Arms (1)

Patients under treatment(s) for GCA

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Unable to consent
• Participation to a randomised controlled clinical trial

Sponsors & Collaborators

• Chugai Pharma France: lead
• ITEC Services: collaborator

Study Sites (1)

Hospital of the Archet

Nice, Alpes-Maritimes, 06202, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Isabelle Idier, Rheumatology Medical Leader
• Organization: ChugaiPF

idier@chugai-pharm.fr

+33 (0) 1 56 37 44 89

Study Officials

• Alfred MAHR, Professor

  alfred.mahr@aphp.fr

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: September 6, 2018
• Study Start: August 2, 2018
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: July 22, 2022
• Results First Posted: May 28, 2020

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)