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    Summary
    EudraCT Number:2012-001980-53
    Sponsor's Protocol Code Number:GORTX-2012
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-15
    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 number2012-001980-53
    A.3Full title of the trial
    Preliminary study on the effectiveness of low doses of Rituximab in patients with Graves’ orbitopathy (GO) poorly responding to immunosuppressive steroid treatment.
    Studio preliminare sull'efficacia della terapia con Rituximab a basse nei pazienti affetti da orbitopatia basedowiana (OB) con scarsa risposta alla terapia immunosoppressiva steroidea standard.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Low doses of Rituximab in Graves orbitopathy
    Bassa dose di Rituximab nell'orbitopatia basedowiana
    A.4.1Sponsor's protocol code numberGORTX-2012
    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 DI MILANO
    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 supportFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    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 pointEndocrinologia e Diabetologia
    B.5.3 Address:
    B.5.3.1Street AddressVia Francesco Sforza, 35
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20122
    B.5.3.4CountryItaly
    B.5.4Telephone number02-50320609
    B.5.5Fax number02-50320605
    B.5.6E-mailpaolo.beckpeccoz@unimi.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 MABTHERA*EV 2F 10ML 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE SpA
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITUXIMAB
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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) Yes
    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
    Active moderate to severe Graves Orbitopathy
    Orbitopatia basedowiana attiva moderata-severa
    E.1.1.1Medical condition in easily understood language
    Active moderate to severe Graves Orbitopathy
    Orbitopatia basedowiana attiva moderata-severa
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10060742
    E.1.2Term Endocrine ophthalmopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Treatment with rituximab of the active phase of GO, prevention of progression to greater severity and reduction of the degree of residual moscle involvement
    Trattamento della fase acuta dell’orbitopatia con rituximab, prevenzione della progressione a forme orbitarie più severe e riduzione del grado di coinvolgimento residuo della motilità estrinseca
    E.2.2Secondary objectives of the trial
    Analysis of rituximab effects at the level of target tissues (thyroid and orbit).
    Analisi degli effetti del rituximab nei tessuti bersaglio sia a livello periferico che d’organo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult caucasian, asian, hispanic, black patients, males and females, aged 18 - 75 yrs, smokers and non smokers, euthyroid for at least 6-8 weeks (defined by normal free thyroid hormone levels), affected by active ophthalmoapthy (clinical activity score ≥4/10 o ≥3/7) of moderate- severe degree, as defined by NOSPECS score. Patients are treated after giving informed consent for therapy. Patients with previous steroid treatment may be included in the study.
    Pazienti adulti, razza caucasica, asiatica, ispanica, maschi e femmine, di età compresa tra i 18 e i 75 anni, fumatori e non, eutiroidei per almeno 6-8 settimane (definiti come presenza di normali livelli di ormoni tiroidei liberi), affetti da oftalmopatia basedowiana in fase attiva (clinical activity score ≥3/7 o ≥4/10) di grado moderato- severo, come definita dallo score NOSPECS. I pazienti vengono trattati dopo aver firmato il consenso informato per la terapia. Possono essere inclusi anche pazienti con precedente trattamento steroideo.
    E.4Principal exclusion criteria
    Contraindications to therapy with rituximab (pregnancy, breast feeding, diabetes, known coronary artery disease, significant cardiac arrhythmias, severe congestive heart failure, other serious chronic illness, active infection, a 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, a history of cancer excluding resected basal or major squamous cell carcinoma, cervical dysplasia or in situ cervical cancer), denied consent to HIV testing, inactive Graves’ ophthalmopathy, previous orbital radiotherapy, refusal of treatment. Patients with known allergy to paracetamol, difenidramine, hydrocortisone.
    Controindicazioni al trattamento con RTX (gravidanza e allattamento, diabete scompensato, patologia coronaria nota, aritmie cardiache significative, scompenso cardiaco severo, altre malattie croniche significative, infezioni in atto, storia di infezioni recidivanti, sarcoidosi, immunodeficienze primarie o secondarie, pregressa infezione tubercolare o pregresso terapia per infezione tubercolare, storia di episodi di ipersensibilità IgE o non Ig E mediata o anafilassi dopo trattamento con proteine di origine murina, pregresso carcinoma ad esclusione di carcinoma basocellulare o squamocellulare cutaneo, displasia cervicale or carcinoma in situ), consenso negato all’esecuzione del test per HIV, oftalmopatia basedowiana inattiva, pregressa radioterapia orbitaria, rifiuto di qualunque trattamento. Pazienti con allergia nota a paracetamolo, difenidramina, ed idrocortisone.
    E.5 End points
    E.5.1Primary end point(s)
    Reduction of clinical activity score ≥2 points or below CAS=3.
    Riduzione del clinical activity score ≥2 punti o al di sotto di CAS=3 at 12 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 12
    A 12 settimane
    E.5.2Secondary end point(s)
    Reduction of severity of GO disease of at least 2 classes NOSPECS; reduction of proptosis ≥2 mm; reduction of lid fissure of at least ≥2 mm; reduction of diplopia according to Gorman Score ≥ 1 class or of the motility of at least 8 degrees; numebr of therapeutic responses; number of active disease recurrences; stadiation of signs of residual disease; improvement of GO-Qol scale of at least 6 points.
    Observational end-point: at week 24 in order to evaluate disease residual and relapses.
    Riduzione della severità di malattia di almeno 2 classi NOSPECS; riduzione della proptosi, diminuzione della fissura palpebrale di almeno 2 mm, riduzione del Gorman score per la diplopia ≥1 classe o della motilità di almeno 8 gradi; numero di risposte terapeutiche, numero di recidive di malattia attiva, quantificazione dei segni di malattia residua; miglioramento della scala Go-Qol di almeno 6 punti.
    End-point osservazionale: a 24 settimane per la valutazione del grado di malattia residua e delle eventuali recidive
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 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 No
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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.1.1Number of subjects for this age range: 0
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 10
    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)
    At the end of the study, patients will be followed according to the standard clinical practice for the GO disease
    Al termine dello studio i pazienti continueranno ad essere seguiti secondo quanto previsto dalla normale pratica clinica prevista per la patologia
    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 Decision2012-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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