Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated for Giant Cells ARTEitis (Horton's Disease) (CARTECEL)

Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated at Nîmes Carémeau University Hospital, for Giant Cells ARTEitis (Horton's Disease), for Diagnosis and During Long-term Follow-up

Giant cell arteritis (GCA) or Horton's disease: frequent large vessel vasculitis (cephalic) (incidence estimated at 9 per 100,000 in France), potentially responsible for blindness.

Treatment: corticosteroid therapy, which is effective in the vast majority of cases.

Clinical problem: relapse; 36% to 44% of patients have a relapse that occurs in the first year for many patients, requiring a re-escalation of corticosteroid therapy, with its consequences:

• Cumulative dose of corticosteroid therapy that causes cardiovascular and infectious morbidity.
• Requires additional immunosuppressive treatment.

Study Overview

• Status: Completed
• Conditions: Giant Cell Arteritis; Horton Disease
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• France
  • Nîmes, France
    • CHUNimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 45 years or older with giant cell arteritis according to ACR criteria or revised criteria incorporating imaging parameters, managed at the University Hospital of Carémeau in Internal Medicine from 01/01/2011 to 01/01/2020.

Description

Inclusion Criteria:

• Patients aged 45 years or older
• Patients with giant cell arteritis according to ACR criteria or revised criteria incorporating imaging parameters,
• Patients managed at the University Hospital of Carémeau in Internal Medicine from 01/01/2011 to 01/01/2020.

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical and paraclinical characteristics of patients diagnosed with ACG	Describe the clinical and paraclinical characteristics of patients diagnosed with ACG to determine whether certain characteristics are significantly associated with a higher risk of developing corticosteroid dependence	day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: Local2019/RG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No