Giant Cell Arteritis: Monitoring Disease Activity and Relapse Risk in Remission

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 observational study enrolls up to 175 adults with giant cell arteritis in remission to see how well vascular ultrasound, patient-reported outcomes, and biobank data reflect disease activity and predict relapse. Participants undergo ultrasound assessments (including blinded reviews at relapse), complete PRO measures, and contribute samples for biobanking over one year. The goal is to identify reliable indicators that could guide tapering of glucocorticoids and inform treatment decisions, especially when IL-6–targeted therapies are used. No experimental interventions are assigned; data collection focuses on monitoring approaches and relapse prediction. Study sites include multiple Danish rheumatology centers led by the University of Aarhus with collaboration across several hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Clinical GCA diagnosis established/confirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis \< 3 years.
2. Clinical remission at the time of inclusion, defined as

   * Having adhered for ≥ 8 weeks prior to inclusion to either (a) the planned tapering of glucocorticoid therapy, or (b) the planned glucocorticoid-sparing DMARD treatment (with or without glucocorticoids).
   * Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.
   * Normal CRP level (\< 10 mg/L) within 7 days before inclusion.
3. Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.
4. A continuous tapering of monotherapy or combination therapy is planned.
5. Age \> 50 years.
6. Study participants must be able to speak and understand spoken and written Danish.

Exclusion Criteria:

1. Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.
2. Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.
3. Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.

Where it's running

• Aarhus University Hospital, Department of Rheumatology
  Aarhus, Denmark Recruiting
• Rigshospitalet Glostrup, Center for Rheumatology and Spine Diseases Rigshospitalet
  Glostrup Municipality, Denmark Recruiting
• Regional Hospital Horsens, Department of Medicine
  Horsens, Denmark Recruiting
• Vejle Hospital, Department of Medicine
  Vejle, Denmark Recruiting
• Aalborg University Hospital, Department of Rheumatology
  Aalborg, Denmark Not yet recruiting
• Hospitalsenhed Midt, Medicinsk Diagnostisk Center
  Silkeborg, Denmark Not yet recruiting

Study contacts

• Study coordinator: Morten Hansen, Medical Doctor
• Email: mothas@rm.dk
• Phone: +45 20187463

Similar studies

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

• Combining vascular ultrasound and blood markers to improve diagnosis and monitoring of giant cell arteritis

  This project will test whether adding extended ultrasound scans to new blood biomarkers can better predict relapse and tell active from inactive giant cell arteritis in people referred for suspected GCA.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07246577

• Orbital blood-vessel inflammation in giant cell arteritis and ischemic optic neuropathy

  This project will test whether advanced FDG PET/MRI with black-blood sequences plus OCT scans can tell if sudden optic nerve damage is due to giant cell arteritis or non-arteritic ischemic optic neuropathy in people aged 50 and older.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Glostrup Municipality · NCT07206238

• Personalized lab test to predict the best treatment for rheumatic diseases

  This project tests a lab-based cell assay to see if it can predict which DMARD will work best for adults with autoimmune rheumatic diseases such as RA, PsA, axSpA, and GCA.

  Recruiting University of Bonn · Bonn, North Rhine-Westphalia · NCT07150000

• Stopping versus reducing tocilizumab for people with well-controlled giant cell arteritis

  This trial will test whether stopping tocilizumab or reducing its dose better maintains remission in people with giant cell arteritis who have been on high-dose tocilizumab for at least 12 months and off steroids for at least three months.

  Recruiting at 7 sites Phase 2 National Institute of Allergy and Infectious Diseases (NIAID) · Atlanta, Georgia and 6 other locations · NCT07108387

• Halo sign in GCA: how soon after steroids to perform Doppler ultrasound

  This study tests whether timing of Doppler ultrasound after starting steroids affects the ability to see the halo sign in adults with giant cell arteritis.

  Recruiting at 4 sites Centre Hospitalier le Mans · Le Mans, Sarthe and 5 other locations · NCT07060274

• Optic nerve sheath ultrasound for diagnosing giant cell arteritis

  This will try using ultrasound to measure the optic nerve sheath to see if it helps diagnose giant cell arteritis in people over 50 with suspected GCA.

  Recruiting Hôpital NOVO · Aix-en-Provence and 8 other locations · NCT07001059

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.