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    Summary
    EudraCT Number:2018-001317-33
    Sponsor's Protocol Code Number:STAGO
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-07
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001317-33
    A.3Full title of the trial
    A Phase II, open-label, ophthalmological external investigator-blinded, single-center, randomized, superiority, no profit, pilot clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in hypercholesterolemic patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy: the STAGO study
    Studio di fase II, in aperto con valutatore esterno oculistico in cieco, monocentrico, randomizzato, di superiorità, no profit, pilota, per valutare gli effetti dell’atorvastatina sull’oftalmopatia basedowiana in pazienti ipercolesterolemici con OB moderata-severa attiva, sottoposti a terapia con glucocorticoidi endovena: studio STAGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, pilot clinical trial to evaluate the effects of atorvastatin on Graves' Orbitopathy (GO) in hypercholesterolemic patients with moderate-to-severe and active GO subjected to intravenous glucocorticoid therapy.
    Studio di fase II, pilota, per valutare gli effetti dell’atorvastatina sull’oftalmopatia basedowiana in pazienti ipercolesterolemici con Oftalmopatia Basedowiana moderata-severa attiva, sottoposti a terapia con glucocorticoidi endovena.
    A.3.2Name or abbreviated title of the trial where available
    STUDIO STAGO
    STUDIO STAGO
    A.4.1Sponsor's protocol code numberSTAGO
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    B.1.3.4CountryItaly
    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 supportUNIVERSITA' DI PISA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOUP
    B.5.2Functional name of contact pointU.O. Endocrinologia 1
    B.5.3 Address:
    B.5.3.1Street AddressVia Paradisa 2
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56124
    B.5.3.4CountryItaly
    B.5.4Telephone number050997346
    B.5.6E-mailmichele.marino@med.unipi.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameATORVASTATINA
    D.3.2Product code [x]
    D.3.4Pharmaceutical form Film-coated 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 INNATORVASTATINA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameAtorvastatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Graves’ orbitopathy is a disabling and disfiguring disease affecting the eyes observed in approximately 25-30% of patients with Graves’ disease. Its clinical manifestations include exophthalmos, inflammatory signs and symptoms, diplopia, and in most severe cases sight impairment.
    L’ oftalmopatia basedowiana è una malattia oculare invalidante che causa un’alterazione dell’aspetto fisico, presente nel 25-30% dei pazienti con Morbo di Basedow. Le sue manifestazioni cliniche includono l’ esoftalmo, segni e sintomi di infiammazione oculare, diplopia, e in alcuni casi piu’ gravi alterazioni dell’acuità visiva.
    E.1.1.1Medical condition in easily understood language
    Graves' Orbitopathy is the eye disease affecting some patients with hyperthyroidism.
    L’oftalmopatia basedowiana è una malattia oculare presente in alcuni pazienti affetti da Morbo di Basedow.
    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 PT
    E.1.2Classification code 10004161
    E.1.2Term Basedow's disease
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of atorvastatin treatment on the overall outcome of Graves’ Orbitopathy at 24 weeks, in hypercolesterolemic patients with Graves’ disease and moderately severe, active Graves’ Orbitopathy to be treated with intravenous glucocorticoids .
    Valutare gli effetti dell’atorvastatina sull’outcome dell’orbitopatia basedowiana a 24 settimane in pazienti ipercolesterolemici con Morbo di Basedow ed Orbitopatia Basedowiana di grado moderatamente grave e attiva sottoposti a terapia con glucocorticoidi endovena
    E.2.2Secondary objectives of the trial
    To investigate the effect of atorvastatin treatment on the overall outcome of Graves’ Orbitopathy at 12 weeks (response measure as above).
    To determine whether atorvastatin reduces the rate of GO relapse at 24 settimane
    Valutare gli effetti dell’atorvastatina sull’outcome dell’orbitopatia basedowiana a 12 settimane. Valutare se l’atorvastatina riduce le recidive a 24 settimane
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Informed consent ; 2) A diagnosis of Graves’ disease; 3) A moderately severe Graves’ orbitopathy; 4) Active Graves’ orbitopathy; 5) No corticosteroids or immunosuppressive treatment for Graves’ orbitopathy in the last 3 months; 6) No previous surgical treatment for GO; 7) No contraindication to GC; 8) Male and female patients of age: 18-75 years; 9) LDL-cholesterol levels of 115-189 mg/dl; 10) No more than one cardiovascular risk factor; 11) Contraceptive method with a failure rate of less than 1% (patients of childbearing potential); 12) No mental illness ; 13) Compliant patient, regular follow-up possible
    1) Consenso informato; 2) Diagnosi di Morbo di Basedow; 3) OB moderatamente grave; 4) OB attiva; 5) Nessun trattamento immunosoppressivo negli ultimi 3 mesi; 6) Nessun trattamento chirurgico per l’Oftlmopatia; 7) Non controindicazioni ai GC; 8) età: 18-75 anni; 9) valori di LDL-colesterolo tra 115-189 mg/dl; 10) assenza di più di un fattore di rischio cardiovascolare; 11) Metodo efficace di contraccezione; 12) Nessuna malattia mentale che impedisca il consenso informato; 13) Paziente compliante.
    E.4Principal exclusion criteria
    1) lack of informed consent; 2) Absence of Graves’ hyperthyroidism; 3) inactive Graves’ orbitopathy; 4) Optic neuropathy; 5) Corticosteroids or immunosuppressive treatment in the last 3 months; 6) Previous surgical treatment for Graves’ orbitopathy; 7) Contraindications to glucocorticoids; 8) Pregnancy, breast-feeding women; 9) Acute or chronic liver disease; 10) Hypersensitivity to atorvastatin or other statins, or hypersensitivity or intolerance to the medication excipients such as lactose; 11) Medications interfering/interacting with statins; 12) Relevant Malignancy; 13) Recent (=1 year) history of alcoholism or drug abuse; 14) Clinical ASCVD (AthroSclerotic CardioVascular Disease); 15) LDL-cholesterol levels =190 mg/dl or presence of more than one associated cardiovascular risk factor;16) Severe familial hyperlipemia
    1) Assenza di consenso informato; 2) Assenza di Morbo di Basedow; 3) Clinical Activity Score <3; 4) neuropatia ottica; 5) trattamenti immunosoppressivi negli ultimi 3 mesi; 6) precedenti trattamenti chirurgici per l’oftalmopatia; 7) Controindicazioni ai glucocorticoidi; 8) Gravidanza, allattamento; 9) malattie epatiche acute o croniche; 10) ipersensibilità ad atorvastatina o eccipienti; 11) farmaci che interferiscono con le statine; 12) tumori concomitanti; 13) Recente (=1 anno) storia di alcolismo o abuso di droghe; 14) Malattie cardiovascolari; 15) livelli di LDL-colesterolo =190 mg/dl o presenza di piu’ di uno tra I fattori di rischio cardiovascolari di cui sopra; 16) grave dislipidemia familiare
    E.5 End points
    E.5.1Primary end point(s)
    Response rate of GO at 24 weeks:

    -Comparison of overall GO outcome (stable, improved, worsened) determined using a composite evaluation as indicated below. The evaluation will be performed by a blinded ophthalmologist and will be documented in the source data, i.e. patient’s fill, and the EUGOGO CRF (4), including the following items:
    - Lid aperture in mm
    - CAS (4) (7 items)
    - Exophthalmos in mm using a Hertel exophthalmometer
    - Eye muscle involvement – diplopia score (Gorman score)
    - Visual acuity using the Snellen chart in log10

    According to the composite evaluation:
    Improvement is defined as change in two of the following outcome measures in at least one eye, without deterioration in any of the same measures in both eyes (compared to baseline):
    - -Improvement in CAS by at least 2 points
    - -Improvement in exophthalmos by at least 2 mm (Hertel exophthalmometer)
    - -Improvement in lid aperture by at least 2 mm
    - -Improvement in diplopia (disappearance or change in the degree)
    - -Improvement of visual acuity by at least 0.2/1

    Worsening is defined as change in two of the following outcome measures in at least one eye (compared to baseline):
    - -Worsening in CAS by at least 2 points
    - -Worsening of exophthalmos [>2 mm (Hertel exophthalmometer)]
    - -Worsening of lid aperture by at least 2 mm
    - -Worsening of diplopia (appearance or change in the degree)
    - -Worsening of visual acuity by at least 0.2/1

    No change is defined as absence of changes or changes smaller than previously defined in any of the previously mentioned parameters.

    - Comparison of a disease specific quality of life questionnaire (GO-QoL).
    Percentuale di risposta dell’oftalmopatia basedowiana a 24 settimane dall’inclusione:

    - Variazione dell’oftalmopatia basedowiana (stabile, migliorata, peggiorata) determinate usando la valutazione complessiva indicata qui sotto. La valutazione sarà eseguita in cieco da un oculista e sarà raccolta nel database ed in una CRF, ed includerà i seguenti parametri:
    - rima palpebrale in mm
    - CAS (7 items)
    - Esoftalmo in mm misurato mediante l’esoftalmometro di Hertel
    - interessamento della motilità oculare– diplopia (Gorman score)
    - acuità visive mediante le carte logaritmiche di Snellen

    Secondo la valutazione complessiva:
    il miglioramento è definito come un cambiamento in due dei seguenti parametri in almeno un occhio, senza peggioramento in nessuno degli stessi parametri in entrambi gli occhi :
    - miglioramento del CAS in almeno 2 punti
    - miglioramento nell’esoftalmo di almeno 2 mm (Hertel exophthalmometer)
    - miglioramento nella rima palpebrale di almeno 2 mm
    - miglioramento della diplopia (scomparsa o cambiamento di grado)
    - miglioramento dell’acuità visiva di almeno 0.2/1

    Il peggioramento è definito come un cambiamento in due dei seguenti parametri in almeno un occhio, (comparato con il basale):
    - peggioramento del CAS in almeno 2 punti
    - peggioramento nell’esoftalmo > 2 mm (Hertel exophthalmometer)
    - peggioramento nella rima palpebrale di almeno 2 mm
    - peggioramento della diplopia (comparsa o cambiamento di grado)
    - peggioramento dell’acuità visiva di almeno 0.2/1

    Nessun cambiamento è definito come assenza di cambiamenti o cambiamenti in misura minore di quelli precedentemente esposti, in nessuno dei parametri misurati.

    - Confronto del punteggio del questionario specifico della qualità della vita (GO-QoL).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoint: 24 weeks
    Secondary endpoints: 12 and 24 weeks
    Endopoint primario: 24 settimane
    Endpoint secondari 12 e 24 settimane
    E.5.2Secondary end point(s)
    1) Response rate (composite eye evaluation and GO-QoL) 12 weeks after inclusion.
    2) GO relapse at 24 weeks (defined as worsening in comparison with the 12 week evaluation).
    1) Tasso di risposta (valutazione complessiva oculare e questionario specifico GO-QoL) a 12 settimane dall’inclusione.
    2) Recidiva dell’oftalmopatia basedowiana a 24 settimane (definite come un peggioramento rispetto alla valutazione a 12 settimane).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints: 12 and 24 weeks
    Endopoints secondari: 12 e 24 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Valutatore oculista in cieco
    Ophthalmological external investigator-blinded
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Glicocorticoidi per via endovenosa
    intravenous glucocorticoid therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state88
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 88
    F.4.2.2In the whole clinical trial 88
    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)
    Patients will undergo a regular endocrinological and ophthalmological follow-up, depending on their response, and to additional treatments for Graves’ orbitopathy if needed, in accordance with the clinical practice Hypercholesterolemia will be treated based on the current guidelines.
    I pazienti saranno sottoposti a regolare monitoraggio endocrinologico e oculistico, a seconda della risposta ottenuta al trattamento e a trattamenti aggiuntivi dell’oftalmopatia basedowiana, ove necessari, in accordo con la pratica clinica. L’ipercolesterolemia verrà trattata basandosi sulle attuali linee guida.
    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 Decision2020-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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