Giant Cell Arteritis: Comparing a Shorter vs. Longer Corticosteroid Taper

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial compares two glucocorticoid tapering regimens for giant cell arteritis. One group receives a conventional taper over about 52 weeks, while the other follows a lighter regimen over roughly 28 weeks, with doses adjusted to body weight. The primary outcome is remission without relapse at week 52, with secondary outcomes including total steroid exposure, steroid-related side effects, and relapse frequency. The trial is multicenter and includes adults aged 50 and older diagnosed by biopsy, imaging, or clinical criteria, and starting oral steroids within 14 days. Results could influence French practice by balancing relapse risk against cumulative corticosteroid exposure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 50 years
* Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American College of Rheumatology (ACR) that given :

  * a temporal artery biopsy compatible with a diagnosis of CAG or
  * an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET scanner or
  * Echo Doppler compatible with a diagnosis of CAG
* Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal to 1 mg / Kg
* Patient wo has given its written consent Patient affiliated with a social security

Exclusion Criteria:

Subjects checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include:

* Early treatment of CAG disease with a dose\> 1 mg / kg whatever the duration
* Corticosteroids already started over 14 days
* Giant arteritis cell on relapse
* dementia syndrome
* No compliant patient
* Patients who live more than 150 km from the investigation center
* Person under judicial protection, guardianship
* Hypersensitivity to prednisone or any of its excipients
* Infection requiring an systemic treatment
* Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus)
* Immunization with live vaccines / mitigated during the 8 weeks preceding inclusion
* Pregnancy, breastfeeding women or women of childbearing potential not using contraception

Where it's running

• CHU de Caen Normandie
  Caen, France Recruiting

Study contacts

• Principal investigator: Hubert De BOYSSON, MD — University Hospital, Caen
• Study coordinator: Hubert De BOYSSON, MD
• Email: deboysson-h@chu-caen.fr
• Phone: 02 31 06 57 32

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How optic nerve swelling changes after starting steroids in giant cell arteritis

  This study tests how quickly the optic nerve sheath swelling decreases after starting glucocorticoids in people with newly diagnosed giant cell arteritis.

  Recruiting Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Montreal, Quebec · NCT07508514

• Precision care for giant cell arteritis and polymyalgia rheumatica

  This long-term observational project will follow adults with giant cell arteritis or polymyalgia rheumatica to see if regular imaging, eye exams, blood tests, and immune cell profiling can better predict aortic complications and steroid side effects over 5–10 years.

  Recruiting Wuerzburg University Hospital · Würzburg · NCT07084480

• Ultrasound lesions in temporal and axillary arteries and relapse risk in giant cell arteritis.

  We will test whether lesions seen on ultrasound of the temporal and axillary arteries can predict relapse in people with giant cell arteritis.

  Recruiting at 2 sites University Hospital, Brest · Brest and 1 other locations · NCT06894602

• Understanding how Giant Cell Arteritis affects vision

  This study is trying to understand how Giant Cell Arteritis affects vision in adults by comparing eye health in those with GCA-related vision problems to those with other causes of vision loss.

  Recruiting ASST Fatebenefratelli Sacco · Milan, Lombardy · NCT06500728

• Understanding biomarkers in giant cell arteritis and polymyalgia rheumatica

  This study is trying to find specific markers in the blood of people newly diagnosed with giant cell arteritis and polymyalgia rheumatica to help doctors understand their disease better and create personalized treatment plans.

  Recruiting University of Bonn · Bonn, North Rhine-Westphalia · NCT06460142

• Investigating a new imaging tracer for diagnosing giant cell arteritis

  This study is testing a new imaging method called AzaFol-PET/CT to see if it can better diagnose giant cell arteritis in people aged 50 and older compared to the current standard method.

  Recruiting Phase 2 Insel Gruppe AG, University Hospital Bern · Bern · NCT06335888

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.