Adrenal InsufficiencyPhase 4RESCUENCT05435781
Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency
A Phase 4 study testing Hydrocortisone in people with Adrenal Insufficiency and Polymyalgia Rheumatica, run by Marianne Christina Klose at 3 sites in Denmark.
Trial summary
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)/giant cell arteritis (GCA) on… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Adrenal Insufficiency, Polymyalgia Rheumatica, Giant Cell Arteritis
- What is being tested?
- Hydrocortisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 3 sitesDenmark
- Study dates
- 7 Jun 2022to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Women must be postmenopausal (FSH is measured at the screening visit)
- A diagnosis of PMR/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.
Who cannot join
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity: 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: Systemic oestrogen treatment (discontinued < 1 month before inclusion), Treatment with strong CYP3A4 inhibitors or inducers, Use of other glucocorticoid formulations (Inhaled corticosteroids, intraarticular or intramuscular injections, steroid creams European steroid group IV-V used in the genital area. Note: 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Endocrinology, Aarhus University Hospital
Aarhus
Jens Otto L. Jørgensen, Professor
- Recruiting
Department of Medical Endocrinology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Ulla Feldt-Rasmussen, Professor, ufeldt@rh.dk
Stina W. Borresen, MD, PhD
- Recruiting
Department of Endocrinology, Odense University Hospital
Odense
Marianne S. Andersen, professor
About this study
Official title: RESCUE - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency; A Multicentre, Randomised, Double Blinded, Placebo-controlled Clinical Trial on Health-related Quality of Life in Patients With Polymyalgia Rheumatica/Giant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.
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)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
Read the detailed description
The study will include patients with PMR/GCA on ongoing prednisolone treatment in a low dose of > 0 mg/day and ≤5mg/day. Eligible patients will undergo a Synacthen® test and 250 patients with a stimulated cortisol level <420 nmol/l (biochemical adrenal insufficiency) will be randomised to either placebo or hydrocortisone supplemental doses during stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA and add supplemental hydrocortisone/placebo in situations of stress according to study protocol. In situations of severe stress (potential adrenal crisis) patients will receive open label hydrocortisone treatment according to routine clinical care. The duration of RESCUE is 6 months but stops earlier if the patient stops prednisolone treatment earlier. In case of a flare of PMR/GCA during the study where prednisolone is increased to >5mg/day for e.g. 5 weeks the study is prolonged accordingly 5 weeks.
Ninety-five patients with stimulated cortisol ≥420 nmol/l (normal adrenal function) will be used as a reference group. The participants will undergo screening and baseline examinations, 3 month's reporting of HRQoL, and with patient consent follow-up through medical records on prednisolone treatment characteristics, and number of hospitalisations.
- Being tested
- Hydrocortisone, Placebo for hydrocortisone
- Keywords
- Glucocorticoid-induced adrenal insufficiency, Prednisolone, Glucocorticoids, Hypothalamic-pituitary-adrenal axis
- Medical subject headings
- Adrenal Insufficiency, Polymyalgia Rheumatica, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention.
Placebo for hydrocortisoneDrug
Patients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| RCT group - hydrocortisone | Active comparator | Patients with polymyalgia rheumatica/giant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response <420 nmol/l) that are randomised to receive hydrocortisone Receives: Drug: Hydrocortisone |
| RCT group - placebo | Placebo comparator | Patients with polymyalgia rheumatica/giant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response <420 nmol/l) that are randomised to receive placebo Receives: Drug: Placebo for hydrocortisone |
| Control group | No intervention | Patients with polymyalgia rheumatica/giant cell arteritis with normal adrenal function (Synacthen test response ≥420 nmol/l) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA
EMA in situations of stress. EMA reporting will be conducted electronically on a smartphone.
Measured: In situations of stress, participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days. Diurnal profiles are generated and one diurnal profile summarizes responses during the day across all 'sick-days'.
Secondary outcomes (31)
Daily 'end-of-day' app-facilitated patient reported outcome (PRO) assessments
Key secondary outcome - obtain information about intercurrent illness, injury, or stress, and symptoms of fatigue, nausea, and general malaise. The questions about symptoms originate from the Danish version of the PRO-CTCAE.
Measured: Patients are asked daily throughout the study period as 'end-of-day' assessments.
SF-36
Key secondary outcome
Measured: At baseline, 3 months and 6 months
AddiQol-30
Key secondary outcome
Measured: At baseline, 3 months and 6 months
PMR/GCA treatment characteristics -accumulated glucocorticoid dose
Key secondary outcome. accumulated glucocorticoid dose
Measured: Information from 6 months before baseline to end-of study
PMR/GCA treatment characteristics -prednisolone treatment duration
Key secondary outcome. Duration of prednisolone treatment, duration of prednisolone tapering (5 mg - 0 mg)
Measured: Information from 6 months before baseline to end-of study
Number of 'sick days'
Key secondary outcome
Measured: Throughout study period (6 months)
Incidens of adrenal crises and hospitalisations
Incidence rate of adrenal crises and hospitalisations
Measured: Throughout study period (6 months)
Adrenal crises grading
Grade of adrenal crises.
Measured: Throughout study period (6 months)
Body composition and muscle strength - DXA scan
Safety outcome for exogenous Cushing's Syndrome (Dual-energy X-ray absorptiometry (DXA) scan: fat percentage, body composition
Measured: Baseline and 6 months
Body composition and muscle strength - Waist, hip, height
Safety outcome for exogenous Cushing's Syndrome (Waist, hip, height)
Measured: Baseline and 6 months
Body composition and muscle strength -weight
Safety outcome for exogenous Cushing's Syndrome (weight)
Measured: Baseline and 6 months
Body composition and muscle strength - body mass index (BMI)
Safety outcome for exogenous Cushing's Syndrome (BMI)
Measured: Baseline and 6 months
Body composition and muscle strength - Timed up and go
Safety outcome for exogenous Cushing's Syndrome (Timed up and go)
Measured: Baseline and 6 months
Body composition and muscle strength - Handgrip strength
Safety outcome for exogenous Cushing's Syndrome (Handgrip strength)
Measured: Baseline and 6 months
Body composition and muscle strength - Short Physical Performance Battery
Safety outcome for exogenous Cushing's Syndrome (Short Physical Performance Battery)
Measured: Baseline and 6 months
Body composition and muscle strength - Chair rising test
Safety outcome for exogenous Cushing's Syndrome (Chair rising test)
Measured: Baseline and 6 months
Bone quality - Dual-energy X-ray absorptiometry (DXA) scan
Safety outcome for exogenous Cushing's Syndrome (DXA scan, vertebral and hip)
Measured: Baseline and 6 months
Bone quality - bone markers in blood and urine
Safety outcome for exogenous Cushing's Syndrome (bone markers in blood and urine)
Measured: Baseline and 6 months
Metabolic and cardiovascular risk - Automated office blood pressure
Safety outcome for exogenous Cushing's Syndrome (Automated office blood pressure)
Measured: Baseline and 6 months
Metabolic and cardiovascular risk (Coagulation and Inflammation markers in blood)
Safety outcome for exogenous Cushing's Syndrome (Coagulation and Inflammation markers in blood)
Measured: Baseline and 6 months
Metabolic and cardiovascular risk - Metabolic and cardiovascular markers in blood and urine
Safety outcome for exogenous Cushing's Syndrome (Metabolic and cardiovascular markers in blood and urine)
Measured: Baseline and 6 months
Patient reported symptoms of hypercortisolism - CushingQol
Safety outcome for exogenous Cushing's Syndrome (CushingQol)
Measured: Baseline and 6 months
Patient reported symptoms of hypercortisolism - Single item Sleep Quality Scale (SQS))
Safety outcome for exogenous Cushing's Syndrome (Single item Sleep Quality Scale (SQS))
Measured: Baseline and 6 months
Biological integrated cortisol status assessment - ACTH test
ACTH test for normalization of adrenal function
Measured: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - 24h urine
24h urine for cortisol and metabolites.
Measured: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - Salivary cortisol/cortisone
Salivary cortisol/cortisone
Measured: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - Circulating biomarkers of glucocorticoid effects and adverse effects
Circulating biomarkers of glucocorticoid effects and adverse effects.
Measured: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - P-cortisol after 24 hours prednisolone pause.
P-cortisol after 24 hours prednisolone pause.
Measured: At baseline, (3 months) and 6 months
ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA
EMA in situations without stress, key-secondary putcome: EMA reporting will be conducted electronically on a smartphone
Measured: EMA is used at fixed time points monthly. Participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days. Diurnal profiles are generated and one diurnal profile summarizes responses during the day across all days.
Influence of the length of the prednisolone pause (0 vs. 1 vs. 2 days) on ACTH test outcome
Forty patients (all on 5 mg prednisolone/day) will undergo two extra ACTH tests after 0 and 2 days of prednisolone pause, meaning last prednisolone dose taken on the day of the test or 2 days before the test, respectively. The exact number of hours of prednisolone pause is registered for each visit. For these patients, samples for ACTH measurements are drawn at each ACTH test, before ACTH injection.
Measured: The ACTH tests are performed at screening (1 day pause) and two extra ACTH tests in the following weeks, every second patient starting with the 2 days pause and every second with the 0 day pause.
Prednisolone cross reactivity in the Roche Elecsys cortisol II immunoassay
Prednisolone cross reactivity in the Roche Elecsys cortisol II immunoassay at different timepoints (hours) since last prednisolone dose is determined in fourty consecutive patients by measuring plasma prednisolone concentrations with LC-MS and cortisol concentrations with both LC-MS and Roche Elecsys cortisol II immunoassay. Blood samples will be collected at 2 and 4 hours plus 1 and 2 days after the last prednisolone dose.
Measured: Blood samples are drawn at the screening, baseline and at the two extra ACTH test visits (0 and 2 days prednisolone pause)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start7 Jun 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomised placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianne Christina Klose
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Responsible party
- Sponsor-investigator, Marianne Christina Klose, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ulla Feldt-Rasmussen, Professor, Principal investigator, Copenhagen University Hospital, RigshospitaletMarianne Klose, MD, PhD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435781
- Sponsor's protocol ID
- RESCUE
- Other IDs
- 2021-002528-18, H-21041930, 2024-518272-30-00
- Acronym
- RESCUE
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data will be made available after completion of the study and publication of the main results, upon reasonable request. Data sharing will comply with GDPR and national data protection regulations.
Publications
Borresen SW, Hansen SB, Al-Jorani H, Tei R, Dreyer AF, Boesen VB, Bislev LS, Jorgensen NT, Jensen RC, Bjergstrom MLL, Christensen LL, Frederiksen JSS, Glintborg D, Bjorner JB, Feldt-Rasmussen U, Jorgensen JOL, Andersen MS, Klose M. Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis on low-dose prednisolone treatment (the RESCUE study). BMJ Open. 2026 Jun 11;16(6):e113110. doi: 10.1136/bmjopen-2025-113110.
PubMed 42276802
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESCUE - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency; A Multicentre, Randomised, Double Blinded, Placebo-controlled Clinical Trial on Health-related Quality of Life in Patients With Polymyalgia Rheumatica/Giant Cell Arteritis Receiving Ongoing Low-dose Prednisolone Treatment.
- ClinicalTrials.gov ID
- NCT05435781
- Acronym / sponsor ID
- RESCUE / RESCUE
- Keywords
- Glucocorticoid-induced adrenal insufficiency, Prednisolone, Glucocorticoids, Hypothalamic-pituitary-adrenal axis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Marianne Christina KloseUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Odense University Hospital
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)/giant cell arteritis (GCA) on ongoing low-dose prednisolone diagnosed with glucocorticoid-induced adrenal insufficiency. The main emphasis is on fatigue (primary outcome) and daily variation hereof during periods of stress.
Detailed description
The study will include patients with PMR/GCA on ongoing prednisolone treatment in a low dose of > 0 mg/day and ≤5mg/day. Eligible patients will undergo a Synacthen® test and 250 patients with a stimulated cortisol level <420 nmol/l (biochemical adrenal insufficiency) will be randomised to either placebo or hydrocortisone supplemental doses during stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA and add supplemental hydrocortisone/placebo in situations of stress according to study protocol. In situations of severe stress (potential adrenal crisis) patients will receive open label hydrocortisone treatment according to routine clinical care. The duration of RESCUE is 6 months but stops earlier if the patient stops prednisolone treatment earlier. In case of a flare of PMR/GCA during the study where prednisolone is increased to >5mg/day for e.g. 5 weeks the study is prolonged accordingly 5 weeks.
Ninety-five patients with stimulated cortisol ≥420 nmol/l (normal adrenal function) will be used as a reference group. The participants will undergo screening and baseline examinations, 3 month's reporting of HRQoL, and with patient consent follow-up through medical records on prednisolone treatment characteristics, and number of hospitalisations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-blinded randomised placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| RCT group - hydrocortisone | Active comparator | Drug: HydrocortisonePatients with polymyalgia rheumatica/giant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response <420 nmol/l) that are randomised to receive hydrocortisone |
| RCT group - placebo | Placebo comparator | Drug: Placebo for hydrocortisonePatients with polymyalgia rheumatica/giant cell arteritis with glucocorticoid-induced adrenal insufficiency (Synacthen test response <420 nmol/l) that are randomised to receive placebo |
| Control group | No intervention | –Patients with polymyalgia rheumatica/giant cell arteritis with normal adrenal function (Synacthen test response ≥420 nmol/l) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 50 years
- Women must be postmenopausal (FSH is measured at the screening visit)
- A diagnosis of PMR/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.
Key exclusion criteria (8 listed)
- Known primary or secondary adrenal insufficiency
- Known Cushing's Syndrome
- Known allergy towards study medication ingredients
- Severe comorbidity: 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisonePatients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention. | Drug | RCT group - hydrocortisone |
| Placebo for hydrocortisonePatients are randomised to either placebo or hydrocortisone supplemental doses in situations of stress. Patients will continue prednisolone treatment and tapering hereof according to current clinical guidelines for PMR/GCA , prednisolone is not part of the intervention. | Drug | RCT group - placebo |
Primary outcome
ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA
Time frame: In situations of stress, participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days. Diurnal profiles are generated and one diurnal profile summarizes responses during the day across all 'sick-days'.
EMA in situations of stress. EMA reporting will be conducted electronically on a smartphone.
31 secondary outcomes
Daily 'end-of-day' app-facilitated patient reported outcome (PRO) assessments
Time frame: Patients are asked daily throughout the study period as 'end-of-day' assessments.
SF-36
Time frame: At baseline, 3 months and 6 months
AddiQol-30
Time frame: At baseline, 3 months and 6 months
PMR/GCA treatment characteristics -accumulated glucocorticoid dose
Time frame: Information from 6 months before baseline to end-of study
PMR/GCA treatment characteristics -prednisolone treatment duration
Time frame: Information from 6 months before baseline to end-of study
Number of 'sick days'
Time frame: Throughout study period (6 months)
Incidens of adrenal crises and hospitalisations
Time frame: Throughout study period (6 months)
Adrenal crises grading
Time frame: Throughout study period (6 months)
Body composition and muscle strength - DXA scan
Time frame: Baseline and 6 months
Body composition and muscle strength - Waist, hip, height
Time frame: Baseline and 6 months
Body composition and muscle strength -weight
Time frame: Baseline and 6 months
Body composition and muscle strength - body mass index (BMI)
Time frame: Baseline and 6 months
Body composition and muscle strength - Timed up and go
Time frame: Baseline and 6 months
Body composition and muscle strength - Handgrip strength
Time frame: Baseline and 6 months
Body composition and muscle strength - Short Physical Performance Battery
Time frame: Baseline and 6 months
Body composition and muscle strength - Chair rising test
Time frame: Baseline and 6 months
Bone quality - Dual-energy X-ray absorptiometry (DXA) scan
Time frame: Baseline and 6 months
Bone quality - bone markers in blood and urine
Time frame: Baseline and 6 months
Metabolic and cardiovascular risk - Automated office blood pressure
Time frame: Baseline and 6 months
Metabolic and cardiovascular risk (Coagulation and Inflammation markers in blood)
Time frame: Baseline and 6 months
Metabolic and cardiovascular risk - Metabolic and cardiovascular markers in blood and urine
Time frame: Baseline and 6 months
Patient reported symptoms of hypercortisolism - CushingQol
Time frame: Baseline and 6 months
Patient reported symptoms of hypercortisolism - Single item Sleep Quality Scale (SQS))
Time frame: Baseline and 6 months
Biological integrated cortisol status assessment - ACTH test
Time frame: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - 24h urine
Time frame: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - Salivary cortisol/cortisone
Time frame: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - Circulating biomarkers of glucocorticoid effects and adverse effects
Time frame: At baseline, (3 months) and 6 months
Biological integrated cortisol status assessment - P-cortisol after 24 hours prednisolone pause.
Time frame: At baseline, (3 months) and 6 months
ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA
Time frame: EMA is used at fixed time points monthly. Participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days. Diurnal profiles are generated and one diurnal profile summarizes responses during the day across all days.
Influence of the length of the prednisolone pause (0 vs. 1 vs. 2 days) on ACTH test outcome
Time frame: The ACTH tests are performed at screening (1 day pause) and two extra ACTH tests in the following weeks, every second patient starting with the 2 days pause and every second with the 0 day pause.
Prednisolone cross reactivity in the Roche Elecsys cortisol II immunoassay
Time frame: Blood samples are drawn at the screening, baseline and at the two extra ACTH test visits (0 and 2 days prednisolone pause)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 42276802Borresen SW, Hansen SB, Al-Jorani H, Tei R, Dreyer AF, Boesen VB, Bislev LS, Jorgensen NT, Jensen RC, Bjergstrom MLL, Christensen LL, Frederiksen JSS, Glintborg D, Bjorner JB, Feldt-Rasmussen U, Jorgensen JOL, Andersen MS, Klose M. Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency: a study protocol for a multicentre, randomised, double-blinded, placebo-controlled clinical trial on health-related quality of life in patients with polymyalgia rheumatica/giant cell arteritis on low-dose prednisolone treatment (the RESCUE study). BMJ Open. 2026 Jun 11;16(6):e113110. doi: 10.1136/bmjopen-2025-113110.
- Individual participant dataSharing planned: Yes. Deidentified patient data will be made available after completion of the study and publication of the main results, upon reasonable request. Data sharing will comply with GDPR and national data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ulla Feldt-Rasmussen, Professor principal investigator
Copenhagen University Hospital, Rigshospitalet
Marianne Klose, MD, PhD principal investigator
Copenhagen University Hospital, Rigshospitalet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone in people with Adrenal Insufficiency and Polymyalgia Rheumatica, run by Marianne Christina Klose at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Klose, MD, PhD (+4530237532, marianne.christina.klose.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ecological momentary assessments (EMA) of the Multidimensional Fatigue Inventory (MFI-20) General Fatigue scale, adjusted for EMA (time frame: In situations of stress, participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days. Diurnal profiles are generated and one diurnal profile summarizes responses during the day across all 'sick-days'.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05435781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.