Phase 4 Vasculitis Trial, Recruiting NCT05435781 Sponsor: Marianne Christina Klose Condition: Vasculitis
Back to Vasculitis

Phase 4 Vasculitis Trial, Recruiting

NCT05435781
Recruiting Phase 4

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
  • If you are a woman, you must be past menopause (this will be checked with a blood test at your first visit)
  • You have been diagnosed with polymyalgia rheumatica (PMR), giant cell arteritis (GCA), or both conditions together
  • You have been taking prednisolone (a steroid tablet) for at least 12 weeks
  • You are still taking prednisolone daily, and your current dose is more than 0 mg but no more than 5 mg, and it must have been at this low dose for at least 2 weeks before your first visit

Who may not be able to join:

  • You have been diagnosed with a condition where your adrenal glands do not work properly (primary or secondary adrenal insufficiency)
  • You have been diagnosed with Cushing's Syndrome (a condition caused by too much of the hormone cortisol)
  • You have a known allergy to any ingredients in the study medication
  • You have a serious ongoing health condition, such as severe heart failure, severe kidney disease, liver cirrhosis, active cancer, a serious immune system disorder, or a history of a psychiatric condition treated by a psychiatric department (for mood-related conditions, this applies only if treatment was within the last year) (confirm with trial site)
  • You drink more than 21 units of alcohol per week
  • You are planning to have major surgery at any point during the study
  • You are taking certain medications that can interfere with cortisol levels or measurements, including systemic oestrogen stopped less than 1 month ago, certain drugs that strongly affect how the body breaks down medications, or certain steroid preparations in specific forms or areas of the body (confirm with trial site for details on which are permitted)
  • You are unable to read and sign a consent form agreeing to take part in the study

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 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Ulla Feldt-Rasmussen, Professor, Rigshospitalet, Denmark

Phone: +4530237532

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 4
Sponsor
Marianne Christina Klose
Registry
ClinicalTrials.gov
Start date
7 June 2022
Est. completion
30 June 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA

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