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New treatment option for Giant Cell Arteritis (GCA)
Official title Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients
ClinicalTrials.gov ID: NCT07060274
What this study is testing
- What it's testing
- Giant cell arteritis (GCA) is a rare disease characterized by vasculitis of the large arterial trunks targeting the thoracic aorta and its dividing branches, affecting adults over the age of 50. Vasculitis lesions cause thickening of the arterial wall, visible on temporal artery biopsy (TAB) or vascular imaging (echo-Doppler, angio-CT, angio-MRI, 18FDG PET-CT).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Patients aged 50 and over
- Without legal protection.
- Meeting GCA classification criteria as defined by ACR 2022 with the presence of a halo sign-unilateral or bilateral-on Doppler ultrasound of the...
- Newly diagnosed with an indication for corticosteroid treatment.
- Have not yet received corticosteroid treatment for GCA.
You likely can't join if
- Patients with a relapse of Giant Cell Arteritis (GCA).
- Patients who have previously undergone a temporal artery biopsy (TAB), including for other reasons.
- Patients who have received oral corticosteroid treatment in the past month or are currently on corticosteroid therapy (excluding hydrocortisone or...
- Patients with other types of vasculitis that may constitute a differential diagnosis: presence of antibodies against the cytoplasm of neutrophils...
- Patients having received immunosuppressive treatment or biotherapy in the month prior to inclusion. If the patient's condition warrants the use of...
See the full eligibility criteria
- Patients aged 50 and over
- Without legal protection.
- Meeting GCA classification criteria as defined by ACR 2022 with the presence of a halo sign-unilateral or bilateral-on Doppler ultrasound of the temporal artery.
- Newly diagnosed with an indication for corticosteroid treatment.
- Have not yet received corticosteroid treatment for GCA.
- No contraindication to corticosteroid treatment.
- Person affiliated with or benefiting from a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).
- Patients with a relapse of Giant Cell Arteritis (GCA).
- Patients who have previously undergone a temporal artery biopsy (TAB), including for other reasons.
- Patients who have received oral corticosteroid treatment in the past month or are currently on corticosteroid therapy (excluding hydrocortisone or local corticosteroids).
- Patients with other types of vasculitis that may constitute a differential diagnosis: presence of antibodies against the cytoplasm of neutrophils (ANCA), positive syphilis serology, positivity of an IGRA test...
- Patients having received immunosuppressive treatment or biotherapy in the month prior to inclusion. If the patient's condition warrants the use of biotherapy or immunosuppressive treatment, its initiation will be...
The study team makes the final eligibility decision.
Where it's taking place
- Le Mans, Sarthe, France
- Angers, France
- Caen, France
- Dijon, France
- La Rochelle, France
- Nantes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Le Mans, Sarthe, France; Angers, France; Caen, France; Dijon, France; La Rochelle, France; Nantes, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.