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The RESCUE study
EU CTIS ID: 2024-518272-30-00
What this study is testing
In this double-blinded randomised placebo-controlled clinical trial, the aim is to determine the effect of supplemental hydrocortisone compared with placebo during mild to moderate physical or mental stress on health related quality of life in patients with polymyalgia rheumatica (PMR) and/or giant cell arteritis (GCA) diagnosed with glucocorticoid-induced adrenal insufficiency while on ongioing low-dose prednisolone treatment. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
- 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
- Women must be postmenopausal
- A diagnosis of polymyalgia rheumatica (PMR), giant cell arteritis (GCA), or both conditions combined
- Treatment with prednisolone ≥12 weeks
- Ongoing prednisolone treatment, with current daily prednisolone dose > 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.
You likely can't join if
- Known primary or secondary adrenal insufficiency
- Known Cushing’ s Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity defined as: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate <30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry).
- Alcohol consumption >21 units per week
- Planned major surgery during the study period at study entry.
See the full eligibility criteria
- Age ≥ 50 years
- Women must be postmenopausal
- A diagnosis of polymyalgia rheumatica (PMR), giant cell arteritis (GCA), or both conditions combined
- Treatment with prednisolone ≥12 weeks
- Ongoing prednisolone treatment, with current daily prednisolone dose > 0 mg and ≤5 mg. The dose must have been ≤5 mg for minimum 2 weeks at the time of the screening visit.
- Known primary or secondary adrenal insufficiency
- Known Cushing’ s Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity defined as: Heart failure (New York Heart Association class IV); Kidney failure with an estimated glomerular filtration rate <30 mL/min (Chronic kidney disease stage 4-5); Liver disease in the form of cirrhosis; Active cancer; Known severe immune deficiency; A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry).
- 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 defined as: Systemic oestrogen treatment (discontinued < 1 month before inclusion); Treatment with strong CYP3A4 inhibitors or inducers (defined in Table 2 in the study protocol); Use of other glucocorticoid formulations: Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. (Permitted glucocorticoid formulations: Eye-drops, nasal spray, glucocorticoid creams European steroid group I-III, and European steroid group IV-V used in the non-genital area only).
- 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.