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

Giant Cell Arteritis Clinical Trial

— CARTECEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142515
• Other study ID #: Local2019/RG-01
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Horton Disease
• Polymyalgia Rheumatica

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	CHUNimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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