NCT04142515

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.2 years

First QC Date

October 25, 2019

Last Update Submit

September 23, 2022

Conditions

Giant Cell ArteritisHorton Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUNimes

Nîmes, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

February 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations

FR(1)