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    Summary
    EudraCT Number:2016-001278-13
    Sponsor's Protocol Code Number:PROSIBD
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-15
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-001278-13
    A.3Full title of the trial
    Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis
    Immunologiset, geneettiset ja mikrobiomitekijät TNFalfa-salpaajalääkityksen hoitovasteen ennustajana - prospektiivinen seurantakohortti Crohnin tautia ja haavaista paksusuolitulehdusta sairastavilla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis
    Immunologiset, perintötekijöihin ja suolistomikrobeihin liittyvät tekijät TNFalfa-salpaajalääkityksen hoitovasteen ennustajana Crohnin tautia ja haavaista paksusuolitulehdusta sairastavilla
    A.3.2Name or abbreviated title of the trial where available
    PROSIBD
    PROSIBD
    A.4.1Sponsor's protocol code numberPROSIBD
    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 SponsorTaina Sipponen
    B.1.3.4CountryFinland
    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 supportHelsinki Unversity
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportTEKES
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki Unversity Hospital
    B.5.2Functional name of contact pointClinic of gastroenterology
    B.5.3 Address:
    B.5.3.1Street AddressHaartmaninkatu 4
    B.5.3.2Town/ cityHelsinki
    B.5.3.4CountryFinland
    B.5.4Telephone number+358504286543
    B.5.6E-mailtaina.sipponen@hus.fi
    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 Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Oyj
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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 nameRemsima
    D.3.4Pharmaceutical form Powder for 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 INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    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) 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 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
    Ulcerative colitis and Crohn's disease
    Haavainen koliitti ja Crohnin tauti
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis and Crohn's disease
    Haavainen paksusuolen tulehdus ja Crohnin tauti
    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 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10013099
    E.1.2Term Disease Crohns
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10058815
    E.1.2Term Crohn's disease acute episode
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10057035
    E.1.2Term Crohn's ileocolitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10011405
    E.1.2Term Crohn's enteritis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10011406
    E.1.2Term Crohn's ileitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10076318
    E.1.2Term Crohn's disease relapse
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10011402
    E.1.2Term Crohn's disease (colon)
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10075466
    E.1.2Term Fistulising Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10066678
    E.1.2Term Acute ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10075465
    E.1.2Term Fistulizing Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10011400
    E.1.2Term Crohn's colitis
    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
    To study
    which genetic, biochemical or inflammatory markers or changes in bowel microbiome predicts the response to infiliximab
    tarkoituksena on selvittää
    mitkä geneettiset, biokemialliset tai tulehdusmarkkerit, tai mikrobiomin muutokset ennustavat parhaiten infliksimabihoidolle saatavaa hoitovastetta
    E.2.2Secondary objectives of the trial
    study
    a) markers that are related to the immunization to infliximab
    b) markers that are related to lose of response to infilximab in IBD
    c) repsonse to biosimilar infilximab
    d) correlation of serum, tissue and fecal consentration of infliximab with endoscopic, cinical and biomarker (calprotectin) response
    tutkia
    a)infilksimabihoidolle immunisoitumiseen liittyviä tekijöitä
    b)hoitovasteen menetykseen liittyviä tekijöitä tulehduksellisissa suolistosairauksissa.
    c) hoitovastetta biosimilaarille infliksimabille
    d)infliksimabin seerumin, kudospitoisuuden ja ulostepitoisuuden korrelaatiota hoitotulokseen mitattuna endoskooppisella, kliinisellä ja biomerkkiaine (kalprotektiini)vasteella

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients (18-64 years of age) with active ulcerative colitis and Crohn's disease not resonsive or intolerant to conventional steroid or immunosuppressive medication
    18-64- vuotiaat aktiivia haavaista koliittia tai Crohnin tautia sairastavat potilaat, joille on alkamassa infliksimabihoito aktiivin IBD:n hoitoon ( ei vastetta konventionaaliselle hoidolle steroidilla ja immunosuppressivisella lääkityksellä tai sille intolerantti).
    E.4Principal exclusion criteria
    pregnancy,
    usual exclusion criteria to TNFalpha-blocking agents: active infection, cancer, severe heart insufficiency, tuberculosis, MS-disease. Indication to infliximab is other than active IBD.
    Raskaus.
    TNFα-salpaajalääkityksen tavanomaiset poissulkukriteerit kuten käynnissä oleva aktiivi infektio, syöpä, vaikea sydämen vajaatoiminta, tuberkuloosi, MS-tauti.
    Infliksimabin hoitoindikaationa muu kuin t kuin aktiivi suolitauti, esim. ekstraintestinaaliset manifestaatiot.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical and endoscopic induction response to infliximab
    Kliininen ja endoskooppinen induktiovaste infiksimabille
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 months after the start of infiximab
    3kk infilksimabilääkityksen aloittamisen jälkeen
    E.5.2Secondary end point(s)
    Clinical and endoscopic induction maintenance response
    Kliininen ja endoskooppinen ylläpitohoitovaste
    E.5.2.1Timepoint(s) of evaluation of this end point
    12months after beginning of infiximab
    12kk inifliksimabihoidon aloituksesta
    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 Yes
    E.6.13.1Other scope of the trial description
    study biochemical or inflammatory markers or changes in bowel microbiome that predicts the response to infiliximab
    geneettiset, biokemialliset tai tulehdusmarkkerit, tai mikrobiomin muutokset, jotka ennustavat parhaiten infliksimabihoidolle saatavaa hoitovastetta
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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.8.3 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.8.5The 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 months5
    E.8.9.1In the Member State concerned 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: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state100
    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)
    None
    Ei
    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 Decision2016-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-31
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