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REPLACE - A multi-centre, randomised, double-blinded, placebo controlled 16-weeks study to compare the effect of hydrocortisone and placebo in patients with Giant Cell Arteritis (GCA)/ Polymyalgia Rheumatica (PMR) with patient-reported symptoms of adrenal insufficiency after cessation of glucocorticoid treatment.
EU CTIS ID: 2024-513822-53-00
What this study is testing
We will perform the first placebo-controlled randomised controlled trial (RCT) in patients with polymylgia rheumatic and giant cell arteritis after planned cessation of glucocorticoid treatment. Our study will be the first evidence-based guidance and aid to glucocorticoid-induced adrenal u patients and thus meet an important need for many thousand patients.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 50 years
- A diagnosis of polymyalgia rheumatic or giant cell arteritis in glucocorticoid free remission for >2 week and <12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks
You likely can't join if
- Known primary or secondary adrenal insufficiency
- Known Cushing´s syndrome
- Severe comorbidity
- Alcohol consumption >21 units per week
- Planned major surgery during the study period at study entry
- Use of drugs that interfere with cortisol metabolism/measurements
See the full eligibility criteria
- Age ≥ 50 years
- A diagnosis of polymyalgia rheumatic or giant cell arteritis in glucocorticoid free remission for >2 week and <12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks
- Known primary or secondary adrenal insufficiency
- Known Cushing´s syndrome
- Severe comorbidity
- Alcohol consumption >21 units per week
- Planned major surgery during the study period at study entry
- Use of drugs that interfere with cortisol metabolism/measurements
- Inability to provide written informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.