Phase 4 Polymyalgia Rheumatica Trial, Recruiting NCT05193396 Sponsor: Marianne Andersen Condition: Polymyalgia Rheumatica
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Phase 4 Polymyalgia Rheumatica Trial, Recruiting

NCT05193396
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
  • You have been diagnosed with Polymyalgia Rheumatica (PMR) or Giant Cell Arteritis (GCA) — two conditions causing inflammation — and are currently in remission (no active symptoms) without steroid tablets, for more than 2 weeks but less than 12 weeks, after having taken a steroid medicine called prednisolone for at least 12 weeks

Who may not be able to join:

  • You have a known problem with your adrenal glands not producing enough hormones (adrenal insufficiency)
  • You have a condition called Cushing's syndrome, where your body has too much of the hormone cortisol
  • You have very severe heart failure (the most serious stage, where symptoms occur even at rest)
  • Your kidneys are working at a significantly reduced level (confirm with trial site for exact measurement)
  • You have severe liver scarring (cirrhosis)
  • You currently have active cancer
  • You have a known serious condition affecting your immune system
  • You have a history of a psychiatric (mental health) illness that needed treatment from a specialist psychiatric department — or, for mood-related conditions specifically, if this happened within the past year
  • You regularly drink more than 21 units of alcohol per week
  • You are already planning to have a major operation during the time the study would run
  • You are taking certain medicines that can affect how the body processes a hormone called cortisol, including: hormone (oestrogen) treatments taken within the last month, or certain strong medicines that affect a liver enzyme called CYP3A4 (confirm with trial site for specific drug names)
  • You are using steroids in certain other forms, such as: inhaled steroids, steroid injections into joints or muscle, or certain strong steroid creams used in the genital area
  • You are unable to read and sign a consent form agreeing to take part

Note on permitted steroid forms: Steroid eye drops, nasal sprays, and most skin creams (except strong creams used in the genital area) are generally allowed (confirm with trial site).


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: Marianne S Andersen, Odense University Hospital

Phone: +4565411807

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 Andersen
Registry
ClinicalTrials.gov
Start date
1 February 2022
Est. completion
1 January 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Adrenal insufficiency symptoms

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