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    Summary
    EudraCT Number:2011-002411-29
    Sponsor's Protocol Code Number:M13-045
    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:2012-03-07
    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 number2011-002411-29
    A.3Full title of the trial
    An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting.
    Sperimentazione multicentrica in aperto per valutare l'™Impatto di Adalimumab sulla qualita' di vita, sui costi e sull'™utilizzo delle risorse sanitarie nella normale pratica clinica in soggetti affetti da Colite Ulcerosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.
    Sperimentazione multicentrica per valutare gli effetti di Adalimumab sulla qualita' di vita, sui trattamenti sanitari e sui costi dell'assistenza sanitaria in soggetti affetti da Colite Ulcerosa
    A.4.1Sponsor's protocol code numberM13-045
    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 SponsorABBOTT 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 supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Bershire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1628644475
    B.5.5Fax number+44 1628 644330
    B.5.6E-maileuclinicatrials@abbott.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 solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 codeNA
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 is a type of inflammatory bowel disease that causes inflammation and sores (ulcers) in the lining of the rectum and colon.
    La Colite Ulcerosa è una malattia infiammatoria intestinale che causa infiammazione e irritazione (ulcere) nel tratto del retto e del colon.
    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 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    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
    Assess the effect of adalimumab on QOL as measured by the Short Inflammatory Bowel Disease (SIBDQ), the utilization of health care resources and the costs of care for the UC subjects treated with adalimumab.
    Valutare gli effetti di adalimumab sulla qualità della vita (QoL) misurata secondo il questionario SIBDQ (Short Inflammatory Bowel Disease Questionnaire), sull'utilizzo delle risorse sanitarie e sui costi delle cure in soggetti affetti da Colite Ulcerosa (CU) trattati con adalimumab.
    E.2.2Secondary objectives of the trial
    Assess the effect of adalimumab on UC subjects' additional QOL measurements and disease activities, as well as to further characterize the safety profile of adalimumab.
    Valutare l'effetto di adalimumab sulle valutazioni aggiuntive della QoL e sullo stato dell’attività della patologia in pazienti con CU, così come di caratterizzare ulteriormente il profilo di sicurezza di adalimumab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects must be male or female between the ages of 18 and 75 years old at Week 0 (Baseline). • Subjects must have a diagnosis of UC for greater than 90 days prior to Week 0 (Baseline) and failed conventional treatment. • Subjects' diagnosis of active UC must be confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy (refer to Section 5.3.1.1 of the protocol for the criteria to perform a flexible sigmoidoscopy). • Subjects must have active UC with a PGA score of 2 or 3 and SIBDQ ≤ 45 at Week 0 (Baseline)
    I soggetti devono essere maschi o femmine di età compresa tra i 18 ei 75 anni alla Settimana 0 (basale). I soggetti devono essere stati diagnosticati con la CU da più di 90 giorni prima della Settimana 0 (basale) e aver fallito il trattamento convenzionale. La diagnosi di CU attiva dei soggetti deve essere confermata da una colonscopia con biopsia o da una sigmoidoscopia flessibile con biopsia (relativamente ai criteri per effettuare la sigmoidoscopia flessibile far riferimento alla sezione 5.3.1.1 del protocollo). I soggetti devono presentare una CU attiva con un punteggio PGA di 2 o 3 e SIBDQ ≤ 45 alla Settimana 0 (Basale).
    E.4Principal exclusion criteria
    • Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for ulcerative colitis or planned bowel surgery or diagnosis of fulminant colitis and/or toxic megacolon or current diagnosis of indeterminate colitis or Crohn's disease. • Subjects with disease limited to the rectum
    Soggetti con storia di colectomia subtotale con ileorettostomia o colectomia con tasca ileoanale, tasca di Kock, o ileostomia per CU o un intervento chirurgico intestinale programmato o diagnosi di colite fulminante e/o megacolon tossico o attuale diagnosi di colite indeterminata o malattia di Crohn. Soggetti con patologia limitata al retto.
    E.5 End points
    E.5.1Primary end point(s)
    Change in SIBDQ at Week 26 from Baseline
    Variazioni nel Questionario SIBDQ alla Settimana 26 dal basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 0, Week 2, Week 8, Week 26/Premature Discontinuation
    Settimana 0, Settimana 2, Settimana 8, Settimana 26/Conclusione anticipata
    E.5.2Secondary end point(s)
    • Change (6 months after versus the previous 6 months) in total UCrelated medical care resources utilization excluding investigational drug use for UC • Change in PGA at Week 26 from Baseline • Change in SCCAI at Week 26 from Baseline • Change (6 months after versus the past 6 months) in costs of UCrelated medical care excluding adalimumab costs • Change (6 months after versus the past 6 months) in total all-cause health care utilization • Change (6 months after versus the past 6 months) in total all-cause direct health care costs • Change (6 months after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs • Reduction (6 months after versus the past 6 months) in UC-related and all-cause hospitalization • Change in EQ-5D scores at Week 26 from Baseline • Change in WPAI at Week 26 from Baseline • Change in patient satisfaction (TSQM) at Week 26 from Baseline • Change (6 months after versus the past 6 months) in UC-related outpatient utilization, including unscheduled consultation, emergency room visits, exam procedures • Percent (%) of subjects with absence of blood in stool at Week 26 • Change in SIBDQ from Baseline over time • Change in PGA from Baseline over time • Change in SCCAI from Baseline over time • Change in EQ-5D from Baseline over time • Change in WPAI from Baseline over time
    Variazioni (nei 6 mesi successivi rispetto ai 6 mesi precedenti) nell’utilizzo delle risorse sanitarie complessive correlate alla CU ad esclusione del farmaco sperimentale per la CU Variazioni di PGA alla Settimana 26 dal basale Variazioni di SCCAI alla Settimana 26 dal basale Variazioni (nei 6 mesi successivi rispetto ai 6 mesi precedenti) nei costi dell’assistenza medica correlata alla CU ad esclusione dei costi per adalimumab Variazioni (nei 6 mesi successivi rispetto ai 6 mesi precedenti) nell’utilizzo delle risorse sanitarie complessive per tutte le cause Variazioni (nei 6 mesi successivi rispetto ai 6 mesi precedenti) nei costi delle risorse sanitarie complessive dirette per tutte le cause Variazioni (nei 6 mesi successivi rispetto ai 6 mesi precedenti) nei costi delle risorse sanitarie dirette e indirette correlate alla CU Riduzione (nei 6 mesi successivi rispetto ai 6 mesi precedenti) dei ricoveri ospedalieri correlati alla CU e per tutte le cause Variazioni nei punteggi del Questionario EQ-5D alla Settimana 26 dal basale Variazioni nell’indice WPAI alla Settimana 26 dal basale Variazioni nella soddisfazione del paziente (TSQM) alla Settimana 26 dal basale Variazioni (nei 6 mesi successivi rispetto ai 6 mesi precedenti) nell’utilizzo di risorse sanitarie ambulatoriali correlato alla CU, comprese visite non programmate, visite di pronto soccorso e procedure Percentuale (%) di soggetti con assenza di sangue nelle feci alla Settimana 26 Variazioni nel Questionario SIBDQ dal basale nel corso del tempo Variazioni nel PGA dal basale nel corso del tempo Variazioni nell’indice SCCAI dal basale nel corso del tempo Variazioni nel Questionario EQ-5D dal basale nel corso del tempo Variazioni nell’indice WPAI dal basale nel corso del tempo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Screening, Week 0, Week 2, Week 8, Week 26/Premature Discontinuation
    Screening, Settimana 0, Settimana 2, Settimana 8, Settimana 26/Conclusione anticipata
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    Qualità della vita
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Canada
    Israel
    Switzerland
    Turkey
    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 Week 26 or premature discontinuation. In addition, there will be a 70-day call/visit after the last dose of study drug.
    La conclusione della sperimentazione è rappresentata dalla settimana 26 o dalla conclusione prematura. Inoltre è prevista una visita/telefonata di follow up a 70 giorni dall'ultima dose di farmaco sperimentale.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months23
    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 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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 180
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 660
    F.4.2.2In the whole clinical trial 680
    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)
    Subjects will be invited to continue the study after discontinuing study drug administration for up to the Week 26 visit. Subjects who early terminate completely from the study will have a Premature Discontinuation Visit within 2 weeks of the last dose of study drug and preferably prior to the initiation of another therapy.
    I soggetti saranno invitati a continuare la sperimentazione dopo la sospensione del farmaco fino alla visita della settimana 26. I soggetti che termineranno completamente la sperimentazione in anticipo saranno sottoposti ad una visita di conclusione anticipata entro due settimane dall'ultima dose di farmaco sperimentale e preferibilmente prima dell'inizio di un'altra terapia.
    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 Decision2012-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-28
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