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    Summary
    EudraCT Number:2015-002127-26
    Sponsor's Protocol Code Number:BAFFI_14
    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:2019-03-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002127-26
    A.3Full title of the trial
    Randomized, single-blind, controlled study of the anti-BAFF antibody belimumab or methylprednisolone treatment in hyperthyroid Graves' disease (GD) and active orbitopathy (GO)
    Randomized, single-blind, controlled study of the anti-BAFF antibody belimumab or methylprednisolone treatment in hyperthyroid Graves' disease (GD) and active orbitopathy (GO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison between treatment with belimumab and methylprednisolone in Graves’hyperthyroidism (GD) and active orbitopathy (GO).
    Confronto tra terapia dell’ipertiroidismo di Graves’ (GD) ed orbitopatia basedowiana (GO) attiva con belimumab vs metilprednisolone
    A.3.2Name or abbreviated title of the trial where available
    BAFFI_14
    BAFFI_14
    A.4.1Sponsor's protocol code numberBAFFI_14
    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 SponsorFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    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 supportGlaxo Smith&Kline GSK International
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
    B.5.2Functional name of contact pointU.O.C. ENDOCRINOLOGIA E DIABETOLOGI
    B.5.3 Address:
    B.5.3.1Street AddressVIA F.SFORZA N. 35
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number0255033498
    B.5.5Fax number0250320605
    B.5.6E-maill.fugazzola@policlinico.mi.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.2.1.1.1Trade name BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO GROUP LIMITED
    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 nameBENLYSTA
    D.3.2Product code L04AA26
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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.IMP: 2
    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 SOLU MEDROL - 500 MG/8 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE DI POLVERE DA 500 MG+ FIALA SOLVENTE DA 8 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    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 nameSOLU MEDROL
    D.3.2Product code D07AA01
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    ORBITOPATIA BASEDOWIANA
    E.1.1.1Medical condition in easily understood language
    GRAVES' ORBITOPATHY
    ORBITOPATIA BASEDOWIANA
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10057889
    E.1.2Term Graves' ophthalmopathy
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) efficacy of therapy on the active inflammatory phase of GO and the progression of the eye disease.
    2) efficacy of therapy in inducing remission of hyperthyroid GD and in reducing the frequency and the degree of hyperthyroidism relapses at the end of anti-thyroid treatment.
    1)efficacia della terapia sull’attività dell’orbitopatia e sulla progressione della malattia oculare
    2)efficacia della terapia nell’induzione della remissione dell’ipertiroidismo della malattia di Graves (GD) e nella riduzione della frequenza e del grado di recidive di ipertiroidismo al termine del trattamento.
    E.2.2Secondary objectives of the trial
    effects of belimumab on the target tissues of GD (the thyrocytes) and GO (the eye muscles, orbital fat and connective tissue) and on thyroid and orbital infiltrating immune cells.
    effetti del belimumab sui tessuti bersaglio della malattia di Graves (GD) (tireociti) e GO (muscolatura orbitale, graddo orbitale e tessuto connettivo) e sulle cellule infiltranti la tiroide e l’orbita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female,18-75 years old; Smokers and non smokers. Women of childbearing potential should use adequate contraception (See “Important Safety Information-Women of Child Bearing Potential” section for specific methods of contraception) during BENLYSTA treatment and for at least 4 months after the last dose. GO at first diagnosis or at the time of relapse, with detectable TSH receptor antibodies. Patients with moderate-severe active GO (clinical activity score 4/10 o 3/7) untreated or previously treated with i.v steroids withdrawn for at least 3 months. Not submitted to previous B cell depleting therapy. Euthyroid for at least 6-8 weeks, on either anti-thyroid medications (tyonamides) to control hyperthyroidism or L-thyroxine for replacement therapy for hypothyroidism. Patients will also be allowed to stay on propranolol treatment for the control of tachycardia.
    Maschi, femmine di 18-75 anni, fumatori e non fumatori. Le donne in età fertile devono utilizzare metodi contraccettivi sicuri (vedi protocollo ““Important Safety Information-Women of Child Bearing Potential” section for specific methods of contraception”) duranet il trattamento con BENLYSTA e per almeno 4 mesi dopo la somministrazione dell’ultima dose). Presenza di GO alla diagnosi o al momento della recidiva con TRAb dosabili. Pazienti con GO attiva di grado moderato-severo (clinical activity score 4/10 o 3/7) non trattata o precedentemente trattata con steroidi e.v. terminati almeno 3 mesi prima dell’arruolamento. Pazienti mai sottoposta ad altre terapia con deplezione B cellulare. Eutirodei per almeno 6-8 settimane sia in terapia tireostatica (tionamidi) per controllare l’ipertiroidismo o in terapia con L-tiroxina sostitutiva per l’ipotiroidismo. Pazienti in terapia con propranololo per il controllo della tachicardia.
    E.4Principal exclusion criteria
    Patients with severe Graves’ orbitopathy (severe keratopathy, compression optic neuropathy and inflammatory optic neuropathy).Treatment with any B cell targeted therapy at any time. Previous oral or intravenous corticosteroid treatment in the last three months not exceeding a cumulative dose of 1 gr. Any immunosuppressant whether biologic or not. Plasmapheresis within 90 days prior to Day 0. Treatment with intravenous immunoglobulin. Azathioprine more than 100 mg/day within 30 days before screening. Administration of live vaccines given within 30 days prior to administration of (Day 0) or concurrently with Belimumab (During study). Splenectomy. Subjects at risk of haemorrhage that threatens a vital organ. History of a major organ transplant or hematopoietic stem cell/marrow transplant. History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. Required management of infections, as follows: currently on any suppressive therapy for a chronic infection, hospitalisation for treatment of infection within 60 days before Day 0, use of parenteral antibiotics within 60 days before Day 0. Pregnancy. Breast feeding. Known coronary artery disease. Significant cardiac arrhythmias. Severe congestive heart failure. Other serious chronic illness. Active infection. History of recurrent clinically significant infection or recurrent bacterial infections. History of sarcoidosis. Primary or secondary immunodeficiency. History of IgE-mediated or non-IgE-mediated hypersensitivity. Known anaphylaxis to mouse-derived proteins. Positive PPD without documentation of treatment for TB infection. Denied consent to HIV testing. Previous orbital radiotherapy, refusal of treatment. Patients with known allergy to paracetamol, difenidramine, hydrocortisone. Patients positive for HBsAg. Patients positive for HBcAb regardless of HBsAb status will undergo HBV DNA which if positive will be excluded. Patients positive at screening Hepatitis C antibody. Positive test for Human Immunodeficiency Virus (HIV) antibody at screening or historically. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater or equal to 3x upper limit of normal (ULN). Alkaline phosphatase and bilirubin >2xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is<35%). Grade 3 / 4 IgG deficiency and IgA deficiency (IgA < 10mg/dL). Lymphocyte count<500/mm3. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including a previous anaphylactic reaction to parenteral administration contrast agents, human or murine proteins or monoclonal antibodies. Major depression. Have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, pose a significant suicide risk. Current drug or alcohol abuse or dependence.
    Pazienti con orbitopatia basedowiana severa (compressione nervo ottico). Trattamento con qualunque teraia anti-cellule B in qualunque tempo. Precedente somministrazione orale o endovenosa di corticosteroidi almeno entro i tre mesi precedenti non eccedente una dose cumulativa di 1 gr. qualunque immunosoppressore sia biologico che no. Plasmaferesi nei 90 giorni precedenti. Trattamento con immunoglobuline e.v. Azatioprina a dosaggio superiore a 10 mg/die nei 30 giorni precedenti lo screening. Somministrazione di vaccini vivi nei 30 giorni precedenti la somministrazione o concomitanti con balimumab (durante lo studio). Splenectomia. Sogetti a rischio per emorragie. Storia di trapianti maggiori o midollari staminali. Storia di tumori maligni negli ultimi 5 anni ad eccezione di tmori curati della pelle (basaliomi o K spinocellulare) o carcinomi in situ della cervice uterina. Richiesta di management delle infezioni come segue: ospedalizzazione per tratamento delle infezini nei 60 giorni prima del giorno 0, uso di antibiotici parenterali nei 60 giorni prima del giorno 0. Gravidanza. Allattamento. Patologia coronarica nota. Aritmie cardiache note. Cardiopatia congestizia. Altre patologie critiche. Storia di ifezioni ricorrenti o batteriche ricorrenti. Storia di sarcoidosi. Immunodeficienza primaria o secondaria. Storia di ipersensibilità IgE e non IgE mediata. Anafilassi nota alle proteine derivate del topo. PPD positivo senza documentazione o trattamento per infezione TB. Consenso negato a test per HIV. Pregressa radioterapia orbitale, rifiuto al trattamento. Pazienti con nota allergia al paracetamolo, difenidramina e idrocortisone. Pazienti con positività per HbsAg. Pazienti positivi per HBcAb indipendentemente dallo stato di HbsAb che verranno sottoposti a HBV DNA che risulti positivo. Pazienti positivi allo screening epatici HCV correlata, HIV. Pazienti con AST e ALT> o uguali a 3x limite superiore di norma. Fosfatasi alcalina e bilirubina >2x. Grado 3/4 IgG deficit e IgA deficit (IgA < 10mg/dL). Conta linfocitaria <500/mm3. Storia di sensibilità a qualunque medicina o compinenti o storia di altre allergie includenti reazioni anafilattiche alla somministrazione parenterale di mezzi di contrasto, umani, murini o antcorpi monoclonali. Depressione maggiore. Rischio di suicidio negli ultimi 6 mesi o idee di suicidio negli ultimi 2 mesi. Uso di droghe o abuso di alcool o dipendenza.
    E.5 End points
    E.5.1Primary end point(s)
    1. Decrease of the clinical activity score (CAS) of 2 points or disease inactivation (CAS<4) in active GO patients at 12, 24, 36 and 48 weeks from belimumab or methylprednisolone administration.
    2. Safety of belimumab therapy in patients with GD and GO.
    1. Riduzione del clinical activity score (CAS) di 2 punti o inattivazione della malattia (CAS<4) in pazienti con GO attiva a 12, 24, 36 e 48 settimane della somministrazione di belimumab o metilprednisolone. 2. Sicurezza della terapia con belimumab in pazienti con GD e GO.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-24-36-48 weeks
    12-24-36-48 settimane
    E.5.2Secondary end point(s)
    1. decrease of GO severity by NOSPECS classes 2 or 3 or 4 of at least 1 point;
    2. analysis of the rate of response to therapy and of relapse of active disease at 12, 24, 36 and 48 weeks;
    3. time (months) to remission of hyperthyroidism and decrease or negativeness of serum TSH receptor antibodies in patients with hyperthyroid GD at ,12, 24, 36 and 48 weeks;
    4. quantification of signs of residual motility abnormalities by motility tests and analysis of quality of life (GO-QoL)
    5. analysis of intrathyroidal and orbital tissue and lymphocyte BAFF expression after therapy by immunohistochemistry and cytofluorimetry.
    1.riduzione della severità della GO espresso come classi NOSPECS 2 o 3 o 4 di almeno 1 punto;
    2.analisi del tasso di risposta alla terapia e rischio di recidiva di malattia attiva a 12, 24, 36 e 48 settimane
    3.tempo (mesi) per la remissione dell’ipertiroidismo e riduzione o negativizzazione degli anticorpi anti-recettore del TSH in pazienti con ipertiroidismo a 12, 24, 36 e 48 settimane
    4.quantificazione dei segni di anomalie della motilità residue mediante test di motilità e analisi della qualità di vita (GO-QoL)
    5.analisi dell’espressione di BAFF a livello intratiroideo, nel tessuto orbitale e sui linfociti dopo terapia mediante immunoistochimica e citofluorimetria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12, 24, 36, 48 weeks
    12, 24, 36, 48 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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 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.8.5.1Number of sites anticipated in the EEA1
    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 years4
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months48
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-03-18. Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    THEY WILL FOLLOWED IN THE ENDOCRINE UNIT AS OUTPUT PATIENTS WITH GRAVES ORBITOPATHY
    VERRANNO SEGUITI PRESSO L'AMBULATORIO DI SECONDO LIVELLO DEDICATO ALLA DIAGNOSI E CURA DELL'ORBITOPATIA BASEDOWIANA
    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 Decision2015-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-30
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