Phase 3 Vasculitis Trial, Recruiting NCT04012905 Sponsor: University Hospital, Caen Condition: Vasculitis
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Phase 3 Vasculitis Trial, Recruiting

NCT04012905
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 50 years of age or older
  • You have been diagnosed with giant cell arteritis (a condition affecting certain arteries) and meet at least 2 out of 4 specific criteria set by the American College of Rheumatology
  • Your diagnosis was confirmed by at least one of the following: a biopsy of the temporal artery (a small artery near the temple), a scan showing inflammation of the large artery in the chest or abdomen, or an ultrasound scan compatible with this diagnosis
  • You have been taking steroid tablets (such as prednisolone) for no more than 14 days, at a starting dose of 1 mg per kilogram of body weight or less
  • You have given written consent to take part in the trial
  • You are covered by social security (confirm with trial site, as this may relate to the French healthcare system)

Who may not be able to join:

  • You were treated for this condition with a steroid dose higher than 1 mg per kilogram of body weight
  • You have already been taking steroid tablets for more than 14 days
  • Your giant cell arteritis has come back after a previous episode (a relapse)
  • You have been diagnosed with dementia
  • You are unlikely to follow the trial's requirements as assessed by the medical team
  • You live more than 150 km (about 93 miles) away from the trial centre
  • You are under legal protection or guardianship
  • You have a known allergy or sensitivity to prednisone (a type of steroid) or any of its ingredients
  • You currently have an infection that requires treatment taken by mouth or injection
  • You have an active viral infection such as hepatitis, herpes, or chickenpox
  • You have received a live or weakened live vaccine within the 8 weeks before joining the trial
  • You are pregnant, breastfeeding, or are a woman who could become pregnant and are not using contraception

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Hubert De BOYSSON, MD, University Hospital, Caen

Phone: 02 31 06 57 32

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
University Hospital, Caen
Registry
ClinicalTrials.gov
Start date
3 March 2021
Est. completion
3 May 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Patient in complete remission over a follow up of 52 weeks, without relapse

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov