Giant Cell ArteritisCARTECELNCT04142515
Collection and Analysis of the Clinical and Biological Characteristics of Patients Treated for Giant Cells ARTEitis (Horton's Disease)
An observational study of Giant Cell Arteritis and Horton Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Giant Cell Arteritis, Horton Disease
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2020to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Giant Cell Arteritis, Horton Disease
- Being tested
- no intervention
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Feb 2020
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142515
- Sponsor's protocol ID
- Local2019/RG-01
- Acronym
- CARTECEL
- Status last verified
- Sep 2022
- First submitted
- 25 Oct 2019
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04142515
- Acronym / sponsor ID
- CARTECEL / Local2019/RG-01
- Conditions
- Giant Cell Arteritis, Horton Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Clinical and paraclinical characteristics of patients diagnosed with ACG
Time frame: day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Horton Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and paraclinical characteristics of patients diagnosed with ACG (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.