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    Summary
    EudraCT Number:2021-002528-18
    Sponsor's Protocol Code Number:RESCUE2131PE9
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-30
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2021-002528-18
    A.3Full title of the trial
    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.
    RESCUE – en videnskabelig undersøgelse af effekten af hydrokortison under stress, hos patienter med nedsat binyrefunktion på grund af fortsat behandling med prednisolon for muskelgigt eller kæmpecelle-karbetændelse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    RESCUE - Effect of supplemental hydrocortisone during stress in prednisolone-induced adrenal insufficiency.
    RESCUE – en videnskabelig undersøgelse af effekten af hydrokortison under stress, hos patienter med nedsat binyrefunktion på grund af fortsat behandling med prednisolon for muskelgigt eller kæmpecelle-karbetændelse.
    A.3.2Name or abbreviated title of the trial where available
    RESCUE
    RESCUE
    A.4.1Sponsor's protocol code numberRESCUE2131PE9
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCopenhagen University Hospital Rigshospitalet
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCopenhagen University Hospital Rigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital Rigshospitalet
    B.5.2Functional name of contact pointDepartment of Medical Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post codeDK-2100
    B.5.3.4CountryDenmark
    B.5.6E-mailstina.borresen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Hydrokortison orion
    D.2.1.1.2Name of the Marketing Authorisation holderOrion
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namehydrokortison
    D.3.2Product code H02AB09
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhydrocortisone
    D.3.9.3Other descriptive nameHYDROCORTISONE
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glucocorticoid-induced adrenal insufficiency
    Glukokortikoid-induceret binyrebarkinsufficiens
    E.1.1.1Medical condition in easily understood language
    Impaired adrenal hormone function induced by treatment with pharmaceutical glucocorticoids
    Nedsat binyrebarkfunktion som følge af behandling med glukokortikoidholdige lægemidler
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001369
    E.1.2Term Adrenal insufficiency NOS
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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/giant cell arteritis (PMR/GCA) on ongioing 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.
    Forsøgets formål er at undersøge, om patienter med hæmmet egenproduktion af binyrebarkhormon på fortsat lavdosis prednisolonbehandling oplever effekt på den helbredsrelaterede livskvalitet, når de modtager stress-doser af hydrokortison ved sygdom og stress.
    E.2.2Secondary objectives of the trial
    Key secondary aims are
    • to determine the association between adrenal function and HRQoL at baseline
    • to determine the effect of hydrocortisone stress doses not only in situations of stress, but for general daily symptom reporting and generic and disease specific HRQoL reported with 4 weeks reference periods.
    • To determine the association between HRQoL and the severity of glucocorticoid-induced adrenal insufficiency (e.g. mild, moderate and severe) i) at baseline and ii) in patients receiving hydrocortisone stress doses compared with placebo.
    • To determine the effect of treating adrenal insufficiency with hydrocortisone stress doses on the ease of tapering prednisolone treatment for PMR/GCA.
    • To determine the effect of stress doses on patient safety regarding hypo- and hypercortisolism (adrenal crises, sick days and hospitalisations, and exogenous cushingoid signs and symptoms)

    Further aims are to investigate biomarkers of glucocorticoid sensitivity and action
    Nøgle sekundære formål:
    • at bestemme sammenhængen mellem binyrebarkfunktionen og helbredsrelateret livskvalitet ved baseline
    • at bestemme effekten af hydrokortison stressdoser ikke kun dage med stres, men for generelle daglige symptomer og generisk og sygdomsspesifikt livskvalitet over længere tid.
    • at bestemme associationen mellem helbredsrelateret livskvalitet og graden af binyrebarkinfussiciens (mild, moderat og svær) dels i) ved baseline og ii) i patienter behandlet med hydrokortison stressdoser vs. placebo.
    • at bestemme om behandling af binyrebarkinsufficiens med stressdoser hydrokortison gør at prednioslonbehandlingen for PMR/GCA kan aftrappes hurtigere.
    • At bestemme effekten af hydrokortison stressdoser på patientsikkerhed ift. symptomer og tegn på hyper- og hypokortisolism (binyrekrise, sygedage, indlæggelser og tegn på exogen Cushing)

    Yderligere formål: at undersøge biomarkører for glukokortikoid sensitivitet og virkning.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • 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.
    • ≥ 50 år
    • kvinder skal være postmenopausale
    • Diagnosticeret med polymyalgia rheumatica og/eller kæmpecellearteritis
    • Behandling med prednisolon ≥ 12 uger
    • Prednisolon-dosis på højst 5 mg om dagen gennem mindst 2 uger på tidspunktet for screeningsbesøget
    E.4Principal exclusion criteria
    • 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. 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.
    • Kendt nedsat binyrebarkfunktion der ikke er udløst af prednisolonforbrug
    • Kendt Cushings Syndrom
    • Alvorlig komorbiditet herunder: hjertesvigt, nyresvigt, levercirrose, aktiv kræftsygdom, immundefekt samt psykisk sygdom der tidligere har krævet indlæggelse (tilstande med depression eller mani, dog kun hvis indenfor det seneste år)
    • Alkoholindtagelse over 21 genstande om ugen
    • Planlagt større kirurgi inden for studieperioden
    • Brug af medicin der påvirker omsætning eller måling af kortisol, herunder østrogen, CYP3A4hæmmere og glukokortikoider
    • Hvis deltageren er ude af stand til at give et informeret samtykke
    E.5 End points
    E.5.1Primary end point(s)
    Symptoms of adrenal insufficiency: daily variation of fatigue (Ecological Momentary Assessments (EMA) of the Multidimensional Fatigue Inventory 20 questions (MFI-20) General Fatigue scale)
    Symptomer på binyrebarkinsufficiens: daglig variation af træthed (Ecological Momentary Assessments (EMA) af Multidimensional Fatigue Inventory 20 questions (MFI-20) General Fatigue skala)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days with ilness or stress
    Dage med sygdom eller stress
    E.5.2Secondary end point(s)
    Key secondary outcomes
    • SF-36, the Physical Health Component Summary
    • PRO-CTCAE symptoms fatigue, nausea and pain
    • AddiQol-30
    • PMR/GCA treatment characteristics (duration of prednisolone tapering from 5 mg to complete withdrawal, accumulated dose of glucocorticoid treatment, duration of prednisolone treatment for PMR/GCA)
    • Number of ‘sick days’

    Safety outcomes
    Adrenal insufficiency
    • Incidence rate and grade of adrenal crises
    • Number of hospitalisations
    Exogenous Cushing’s Syndrome
    • Body composition and muscle strength (Dual-energy X-ray absorptiometry (DXA) scan: fat percentage, body composition, bone mineral density, Waist, hip, weight, height, body mass index (BMI), Timed up and go, Handgrip strength, Short Physical Performance Battery and chair rising test
    • Bone quality (Bone markers in blood and urine)
    • Metabolic and cardiovascular risk (Automated office blood pressure, Coagulation and Inflammation markers in blood, Metabolic and cardiovascular markers in blood and urine)
    • Patient reported symptoms (CushingQol, Single item Sleep Quality Scale (SQS)

    Exploratory outcomes
    • Health-Related Quality of Life measured by SF-36 eight domain scores and Mental Health Component Summary
    • PMR/GCA treatment characteristics: Number of PMR/GCA disease flare up/relapse, and disease activity of the PMR/GCA.
    • Biological integrated cortisol status assessment (ACTH test for normalization of adrenal function, 24h urine, Salivary cortisol, Circulating biomarkers of glucocorticoid effects and adverse effects, P-cortisol after 24 hours prednisolone pause analysed with several methods)
    Centrale sekundære endepunkter:
    • SF-36, the Physical Health Component Summary
    • PRO-CTCAE symptomer: træthed, kvalme, smerte
    • AddiQol-30
    • PMR/GCA behandlingskarakteristika (varighed af prednioslon aftrapning fra 5 mg/dag til seponering, akkumuleret dosis glukokortikoidbehandling, varighed af prednisolonbehandling for PMR/GCA
    • Antal sygedage

    Sikkerheds endepunkter
    Binyrebarkinsufficiens
    • Incidens rate og graden af binyre kriser
    • antal hospitalsindlæggelser
    Exogen Cushing’s Syndrom
    • Kropssammensætning og muskelstyrke (Dual-energy X-ray absorptiometry (DXA) scanning: fedtprocent, kropssammensætning, knogle mineralindhold; hofte- og talje omfang, højde kropsvægt, body mass index (BMI), Timed up and go, Handgrip strength, Short Physical Performance Battery og chair rising test
    • Knogle kvalitet (knoglemarkører i blod og urin)
    • Metabolsk og kardiovaskulær risiko (blodtryk samt koagulations, inflammations- metaboliske- og kardiovaskulære markører i blod og urin
    • Patient reporteret symptomer (CushingQol, Single item Sleep Quality Scale (SQS)

    Exploratoriske endepunkter
    • Helbredsrelateretlivskvalitet: SF-36 8 domain scores og Mental Health Component Summary
    • PMR/GCA behandlingskarakteristika: antal PMR/GCA flares/relapse, sygdomsaktivitet.
    • Biologisk integreret kortisol status undersøgelse
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, 3 months, 6 months
    baseline, 3 mdr., 6. mdr.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 162
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 163
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state325
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 325
    F.4.2.2In the whole clinical trial 325
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    none
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-22
    P. End of Trial
    P.End of Trial StatusOngoing
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