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    Summary
    EudraCT Number:2014-003855-76
    Sponsor's Protocol Code Number:GA29145
    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:2021-06-08
    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 number2014-003855-76
    A.3Full title of the trial
    AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144
    STUDIO IN APERTO DI ESTENSIONE E DI MONITORAGGIO DELLA SICUREZZA IN PAZIENTI AFFETTI DA MORBO DI CROHN ATTIVO DA MODERATO A GRAVE PRECEDENTEMENTE ARRUOLATI NELLO STUDIO DI FASE III PROTOCOLLO GA29144 SU ETROLIZUMAB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment for patients with moderately to severely active Crohn's disease
    Studio in aperto di estensione per valutare la sicurezza a lungo termine e l'efficacia di etrolizumab nei pazienti affetti da Morbo di Crohn da moderato a grave
    A.3.2Name or abbreviated title of the trial where available
    An Open-Label Extension Study to assess the long-term safety and effective of etrolizumab treatment
    Studio in aperto di estensione per valutare la sicurezza a lungo termine e l'efficacia di etrolizuma
    A.4.1Sponsor's protocol code numberGA29145
    A.5.4Other Identifiers
    Name:GA29145Number:GA29145
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0
    B.5.5Fax number0
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    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 No
    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 nameEtrolizumab
    D.3.2Product code Ro549-0261/F04-02
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtrolizumab
    D.3.9.1CAS number 1044758-60-2
    D.3.9.2Current sponsor codeRO5490261
    D.3.9.3Other descriptive nameEtrolizumab
    D.3.9.4EV Substance CodeSUB75320
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number105
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale umanizzato
    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
    Crohn's disease
    Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    A form of inflammatory bowel disease
    Malattia infiammatoria dell'intestino
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this open-label extension-safety monitoring (OLE-SM) study are as follows:
    Part 1 (Open-Label Extension; OLE)
    ¿ To assess the long-term safety and efficacy of etrolizumab in patients eligible for Part 1 (OLE)
    Part 2 (Safety Monitoring; SM)
    ¿ Progressive multifocal leukoencephalopathy (PML) safety monitoring in patients who have stopped study treatment
    Safety Objectives
    The other safety objectives for this study are as follows:
    Part 1 (OLE)
    ¿ To evaluate the incidence, rate per subject-year, and severity of infection-related adverse events
    ¿ To evaluate the incidence and rate per subject-year of malignancies
    ¿ To evaluate the incidence and severity of hypersensitivity reactions
    ¿ To evaluate the incidence and the clinical significance of antitherapeutic
    antibodies (ATAs)
    Gli obiettivi di questo studio di estensione in aperto e di monitoraggio della sicurezza (OLE-SM) sono i seguenti:
    Parte 1 (Estensione in aperto [Open-Label Extension, OLE])
    - Valutare la sicurezza e l¿efficacia a lungo termine di etrolizumab nei pazienti idonei alla Parte 1 (OLE)
    Parte 2 (Monitoraggio della sicurezza [Safety Monitoring, SM])
    - Monitoraggio della sicurezza associato alla leucoencefalopatia multifocale progressiva (Progressive Multifocal Leukoencephalopathy, PML) nei pazienti che hanno interrotto il trattamento dello studio
    Obiettivi di sicurezza
    Gli altri obiettivi di sicurezza per questo studio sono i seguenti:
    Parte 1 (OLE)
    - Valutare l¿incidenza, il tasso per soggetto all¿anno e la gravit¿ degli eventi avversi correlati
    all¿infezione
    - Valutare l¿incidenza e il tasso per soggetto all¿anno di neoplasie maligne
    - Valutare l¿incidenza e la gravit¿ delle reazioni da ipersensibilit¿
    - Valutare l¿incidenza e l¿importanza clinica degli anticorpi antiterapeutici (ATA)
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part 1 Open-label Extension:
    -Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the eligibility criteria for open-label etrolizumab as described in the protocol
    Part 2 Safety Monitoring:
    -Patients who participated in etrolizumab Phase III study GA29144 and are not eligible or choose not to enter Part 1
    -Patients who transfer from Part 1
    -Completion of the 12-week safety follow-up period prior to entering
    Parte 1 (OLE)
    • Pazienti precedentemente arruolati nello studio di fase III GA29144 che presentano i criteri di eleggibilità per lo studio in aperto come descritto nel protocollo
    PARTE 2 (SM)
    • Pazienti che hanno partecipato allo Studio di fase II GA29144 e che non sono idonei o hanno deciso di non arruolarsi nella Parte 1 (OLE)
    • Pazienti che provengono dalla Parte 1 (OLE) di questo protocollo
    • Completamento del periodo di follow-up di sicurezza di 12 settimane prima dell'ingresso
    E.4Principal exclusion criteria
    Part 1 Open-label Extension:
    - Any new, significant, uncontrolled condition
    Part 2 Safety Monitoring:
    - Non ci sono criteri di esclusione
    Parte 1 OLE:
    - Qualsiasi nuova, significativa condizione non controllata
    Parte 2 SM:
    - Non ci sono criteri di esclusione
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy outcome measures:
    • CDAI remission assessed at 12-week intervals during Part 1 (OLE)
    • PRO2 remission assessed at 12-week intervals during Part 1 (OLE)
    • Simplified Endoscopic Index for Crohn's disease (SES-CD) score assessed at Week 108 or at early withdrawal, if prior to Week 108, during Part 1 (OLE)
    Safety Outcome Measures
    Part 1 (OLE)
    • Incidence and severity of adverse events
    • Incidence of serious adverse events
    • Incidence, rate per subject-year, and severity of infection-related
    adverse events
    • Incidence of serious infection-related adverse events
    • Incidence and severity of injection-site reactions
    • Incidence of adverse events leading to etrolizumab discontinuation
    • Incidence of laboratory abnormalities
    • Incidence and rate per subject-year of malignancies
    • Incidence of ATAs to etrolizumab
    • Incidence and severity of hypersensitivity reaction events
    Part 2 (SM)
    • Incidence of suspected or confirmed PML events
    Misure di esito relative all’efficacia:
    Le misure di esito relative all’efficacia per questo studio sono le seguenti:
    - Remissione secondo il punteggio CDAI valutata a intervalli di 12 settimane durante la Parte 1 (OLE)
    - Remissione secondo il punteggio PRO2 valutata a intervalli di 12 settimane durante la Parte 1 (OLE)
    - Punteggio endoscopico semplificato per il morbo di Crohn (SES-CD) valutato alla Settimana 108 o al ritiro anticipato, se precedente alla Settimana 108,
    durante la Parte 1 (OLE)
    Misure di esito relative alla sicurezza
    Parte 1 (OLE)
    - Incidenza e gravità degli eventi avversi
    - Incidenza degli eventi avversi gravi
    - Incidenza, tasso per soggetto all’anno e gravità degli eventi avversi correlati all’infezione
    - Incidenza degli eventi avversi gravi correlati all’infezione
    - Incidenza e gravità delle reazioni nel sito dell’iniezione
    - Incidenza degli eventi avversi che hanno portato alla sospensione di etrolizumab
    - Incidenza delle anomalie di laboratorio
    - Incidenza e tasso per soggetto all’anno di neoplasie maligne
    - Incidenza di ATA per etrolizumab
    - Incidenza e gravità delle reazioni da ipersensibilità
    Parte 2 (SM)
    - Incidenza degli eventi di PML sospetta o confermata
    E.5.1.1Timepoint(s) of evaluation of this end point
    • CDAI remission assessed at 12-week
    • PRO2 remission assessed at 12-week
    The CDAI and PRO2 scores will be calculated, and the APQ (Abdominal
    Pain Questionnaire) will be completed every 12 weeks and at Study
    Completion
    • SES-CD at 108 weeks or at early withdrawal
    Safety Outcome Measures (Part 1 and 2)
    • Weeks, 0, 4, 8, 12 and then every 12 weeks thereafter
    • CDAI di remissione valutato a 12 settimane
    • PRO2 di remissione valutato a 12 settimane
    I punteggi CDAI e PRO2 saranno calcolati, e l'APQ (Abdominal Pain Questionnaire) saranno effettuati ogni 12 settimane e al completamento dello studio
    • SES-CD a 108 settimane, o al ritiro anticipato Misure di esito relative alla sicurezza (parte 1 e 2)
    • Settimane, 0, 4, 8, 12 e poi ogni 12 settimane
    E.5.2Secondary end point(s)
    Not Applicable
    Non presente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    Non presente
    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 No
    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) 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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Estensione e sicurezza
    Extension and safety
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA200
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Israel
    Korea, Democratic People's Republic of
    Korea, Republic of
    Mexico
    New Zealand
    Russian Federation
    Serbia
    South Africa
    Turkey
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Estonia
    France
    Germany
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Poland
    Romania
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Argentina
    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
    The end of the study is defined as the date when the last patient completes the 92-week PML safety-monitoring period.
    La fine dello studio ¿ definita come la data in cui l'ultimo paziente completa le 92 settimane del periodo di sicurezza per la PML (leucoencefalopatia multifocale progressiva)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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.1.1.1In 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: 1200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 565
    F.4.2.2In the whole clinical trial 1250
    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 not receive any etrolizumab treatment from the study sponsor after the end of the study. Patients should receive standard of care treatment or treatments that meet the needs of the patient as
    prescribed by their physician.
    I pazienti no riceveranno il farmaco etrolizumab direttamente dallo Sponsor alla fine dello studio. I pazienti potranno ricevere terapia standard o trattamenti che incontrano i loro bisogni in accordo a quanto prescritto dal loro medico.
    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 Decision2016-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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