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    Summary
    EudraCT Number:2015-001346-29
    Sponsor's Protocol Code Number:M10-870
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2016-10-12
    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 number2015-001346-29
    A.3Full title of the trial
    A Multi-Center, Open-Label
    Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated
    Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290
    Studio multicentrico, in aperto sull'anticorpo monoclonale umano anti TNF adalimumab
    per valutare la sicurezza e tollerabilità a lungo termine di somministrazioni ripetute di adalimumab in pazienti pediatrici affetti da
    colite ulcerosa che hanno completato lo studio M11-290
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-Center, Open-Label Study of the Human Anti TNF Monoclonal
    Antibody Adalimumab administered to children with Ulcerative Colitis Who Completed the Study M11-290
    to Evaluate Long-Term Safety and Tolerability of the drug
    Sperimentazione multicentrica, in aperto
    sull’anticorpo monoclonale umano anti-TNF adalimumab somministrato a bambini affetti da colite ulcerosa che hanno terminato lo studio M11-290 per valutare la sicurezza e la tollerabilità a lungo termine del farmaco
    A.3.2Name or abbreviated title of the trial where available
    M10-870
    M10-870
    A.4.1Sponsor's protocol code numberM10-870
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Deutschland GmbH & Co. KG - Germania
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbvie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628 561090
    B.5.5Fax number+44 1628 461153
    B.5.6E-maileu-clinical-trials@abbvie.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 Yes
    D.2.1.1.1Trade name HUMIRA - 40 MG SOLUZIONE INIETTABILE USO SOTTOCUTANEO 1 PENNA PRERIEMPITA O,8 ML +1 TAMPONE IMBEVUTO DI ALCOL IN 1 BLISTER
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE 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 nameADALIMUMAB
    D.3.2Product code 331731-18-1
    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 INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeHumira
    D.3.9.3Other descriptive nameADALIMUMAB
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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) 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.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
    Ulcerative Colitis
    colite ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    Colite Ulcerosa
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to evaluate the
    long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects
    with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52.
    L’obiettivo dello studio è valutare la sicurezza, la tollerabilità e il mantenimento della risposta clinica
    a lungo termine di somministrazioni ripetute di adalimumab in soggetti pediatrici affetti da colite ulcerosa (UC), che hanno
    partecipato al protocollo M11 290 e che lo hanno completato con esito positivo fino alla Settimana 52.
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Serologic markers
    Marker sierologici
    E.3Principal inclusion criteria
    Subjects successfully enrolled in and completed Protocol M11-290 through Week 52.
    Soggetti arruolati nel protocollo M11 290 e che hanno completato con esito positivo la sperimentazione fino alla Settimana 52.
    E.4Principal exclusion criteria
    Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870.
    Soggetto che lo sperimentatore, per qualsiasi motivo, ritiene non essere un candidato idoneo al proseguimento della terapia con
    lo studio M10 870.
    E.5 End points
    E.5.1Primary end point(s)
    This study will utilize the PMS (and Mayo
    score if available) and PUCAI
    to determine efficacy of the study drug
    Lo studio utilizzerà il PMS (ed il Mayo score se disponibile) ed il PICAI per determinare l'efficacia del
    farmaco in studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Premature
    Visita Basale, Settimane 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Prematura
    Discontinuazione
    E.5.2Secondary end point(s)
    Safety analyses will be performed on all
    subjects who receive at least
    one dose of study drug.
    Analisi di sicurezza saranno effettuate su tutti i soggetti che hanno ricevuto almeno una dose di
    farmaco
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Premature
    Discontinuation
    Visita Basale, Settimane 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Prematura
    Discontinuazione
    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 Yes
    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
    Studio di estensione in aperto
    Open label extension study
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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 No
    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
    Canada
    Israel
    Japan
    New Zealand
    Switzerland
    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
    The end of the study is defined as the date of the last visit of the last patient (LPLV) or the last follow up contact, whichever is
    longer.
    La fine dello studio è definita come la data dell’ultima visita dell’ultimo soggetto (LPLV) o l’ultimo contatto di follow-up, quello che
    dei due avviene più tardi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 Yes
    F.1.1Number of subjects for this age range: 73
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 53
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally
    Soggetti minori incapaci di dare personalmente il proprio consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 93
    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)
    Upon completion of the study, the subjects will be treated in accordance with the Investigator's best clinical
    judgement.
    Al completamento dello studio, i soggetti verranno trattati in accordo al miglior giudizio clinico dello Sperimentatore
    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 Decision2015-10-02
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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