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    The EU Clinical Trials Register currently displays   44157   clinical trials with a EudraCT protocol, of which   7327   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-004904-31
    Sponsor's Protocol Code Number:IFX4501
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-29
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-004904-31
    A.3Full title of the trial
    An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.
    Een open-label, multicentrum Fase IV studie, om de serum concentratie Remsima™ (infliximab biosimilar) in het bloed te onderzoeken nadat patiënten met de ziekte van Crohn, Colitis Ulcerosa of Reumatoïde Artritis die in remissie zijn, zijn omgeschakeld van Remicade (infliximab).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.
    Een klinische studie om de concentratie Remsima™ (infliximab biosimilar) in het bloed te onderzoeken nadat patiënten met de ziekte van Crohn, Colitis Ulcerosa of Reumatoïde Artritis in remissie zijn omgeschakeld van Remicade (infliximab).
    A.4.1Sponsor's protocol code numberIFX4501
    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 SponsorMundipharma Pharmaceuticals B.V.
    B.1.3.4CountryNetherlands
    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 supportMundipharma Pharmaceuticals B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMundipharma Pharmaceuticals B.V.
    B.5.2Functional name of contact pointDr. Y.J.B. van Megen
    B.5.3 Address:
    B.5.3.1Street AddressLeusderend24
    B.5.3.2Town/ cityLeusden
    B.5.3.3Post code3832 RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31334508270
    B.5.6E-mailyvonne.vanmegen@mundipharma.nl
    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 (infliximab)
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Powder for concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).
    Ziekte van Crohn, Colitis Ulcerosa, Reumatoïde Arthritis.
    E.1.1.1Medical condition in easily understood language
    rheumatoid arthritis (disease that affects joints), Crohn's Disease (disease that may affect gastrointestinal tract), Ulcerative Colitis (disease of the colon).
    reumatoïde artritis (ontstekingen van de gewrichten), de ziekte van Crohn (chronische aandoening van het maagdarmkanaal) of colitis ulcerosa (ontstekingsziekte van de dikke darm)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that the infliximab serum concentration of Remsima™ is non-inferior to the infliximab serum concentration of Remicade , 16 weeks after switch from Remicade to Remsima™ in subjects with CD, UC or RA in stable remission for > 30 weeks measured by a bridging enzyme-linked immunosorbent assay (ELISA).
    Om aan te tonen dat de infliximab serumconcentratie van Remsima™ niet inferieur is aan de infliximab serum concentratie van Remicade, 16 weken nadat patiënten met de ziekte van Crohn, colitis ulcerosa of reumatoïde artritis die in stabiele remissie zijn gedurende > 30 weken, zijn omgezet van Remicade naar Remsima™, gemeten door middel van een 'bridging enzyme-linked immunosorbent assay' (ELISA).
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age ≥18 years.
    2. Subject will have a confirmed diagnosis of RA, UC or CD.
    3. Stable remission defined as HBI≤4, SCCAI<3, DAS 28<3.2 at screening.
    4. Stable and continuous treatment with Remicade during the last 30 weeks, and no foreseen dose adjustment for the coming 2 months for infliximab.
    5. Stable concomitant treatment; if concomitant drugs than stable for 4 months and no foreseen changes in drugs.
    For RA: stable and continuous treatment with MTX.
    6. Non-pregnant, non-nursing female.
    7. Subject capable of understanding and signing an informed consent form.
    1. Man of vrouw, 18 jaar of ouder.
    2. Bij de persoon is middels klinische diagnose reumatoïde artritis, colitis ulcerosa of de ziekte van Crohn vastgesteld.
    3. Tijdens moment van screening is de ziekte stabiel gedefineerd als HBI≤4, SCCAI<3, DAS 28<3.2.
    4. Gedurende de laatste 30 weken is de persoon stabiel en continu behandeld met Remicade en wordt in de komende 2 maanden geen aanpassing van de dosering van infliximab voorzien.
    5. Stabiele behandeling met comedicatie; indien sprake is van comedicatie dan moet het gebruik gedurende de afgelopen 4 maanden stabiel zijn en worden geen veranderingen in deze medicatie verwacht.
    Voor personen met Reumatoïde Arthritis: stabiele en continue behandeling met MTX.
    6. Vrouwen mogen niet zwanger zijn. Daarnaast mogen vrouwen geen borstvoeding geven.
    7. Personen moeten begrijpen wat de toestemmingsprocedure inhoudt en in staat zijn schriftelijk toestemming te geven om deel te nemen aan de studie.
    E.4Principal exclusion criteria
    1. Subjects with evidence of the following major co-morbidities such as: severe diabetic mellitus, tuberculosis (TB), severe infections, uncontrollable hypertension, severe cardiovascular disease (New York Heart Association [NYHA] class 3 or 4) and/or severe respiratory diseases.
    2. Any other condition/disease, which in the opinion of the investigator makes the subject ineligible for the study.
    3. Any clinically relevant hypersensitivity to (anaphylaxis or infusion related reactions) infliximab or to other murine proteins
    4. Change of major co-medication during the last 4 months prior to screening and foreseen dose adjustment during the next 2 months:
    RA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication, which according to the investigator would interfere with the stability of the disease.
    UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication, which according to the investigator would interfere with the stability of the disease.
    5. Change in treatment with Remicade during the last 30 weeks due to disease related factors, not including dose/frequency adjustments due to serum infliximab concentration measurements.
    6. Simultaneous treatment with another biological or a not registered NCE.
    7. Psychiatric or mental disorders, alcohol abuse or other substance abuse (and/or history of opioid abuse), language barriers or other factors which makes adherence to the study protocol impossible.
    8. Inadequate birth control, pregnancy, and/or breastfeeding.
    1. Personen met: ernstige diabetes mellitus, tuberculose (TB), een ernstige infectie, ongecontroleerde hypertensie, een ernstige cardiovasculaire aandoening (klasse 3 of 4 volgens de criteria van de New York Heart Association [NYHA]), en/of een ernstige respiratoire aandoening.
    2. Elke andere ziekte of aandoening die de persoon volgens de onderzoeker ongeschikt maakt om deel te nemen aan dit onderzoek.
    3. Klinisch relevante overgevoeligheid voor infliximab of andere muizeneiwitten (anafylaxie of infusie gerelateerde reacties).
    4. Een wijziging gedurende de laatste 4 maanden voor de screening in de comedicatie en een verwachte aanpassing van de dosering in de komende twee maanden:
    - Reumatoïde artritis: het gebruik van systemische corticosteroïden, synthetische DMARDs, of een ander medicijn dat de stabiliteit van de ziekte verstoort.
    - colitis ulcerosa/ziekte van Crohn: het gebruik van systemische corticosteroïden, een immuunsuppressivum, of een ander medicijn dat de stabiliteit van de ziekte verstoort.
    5. Een wijziging in de behandeling met Remicade in de voorafgaande 30 weken, veroorzaakt door de ziekte, met uitsluiting van wijzigingen in de dosering/frequentie vanwege infliximab serum concentraties van Remicade.
    6. Gelijktijdige behandeling met een tweede biological of een niet geregistreerd geneesmiddel.
    7. Een psychische/psychiatrische stoornis, alcoholverslaving, een drugsverslaving (inclusief een verslaving aan pijnstillers), taalbarrières, of een andere factor die het voor de persoon onmogelijk maakt het studieprotocol te volgen.
    8. Onvoldoende gebruik van anticonceptiemiddelen, zwangerschap, en/of het geven van borstvoeding.
    E.5 End points
    E.5.1Primary end point(s)
    Infliximab serum concentration of Remsima™ 16 weeks after switch from Remicade by ELISA compared to baseline.
    Infliximab serum concentratie van Remsima™ bepaald d.m.v. ELISA, 16 weken na de omschakeling van Remicade, in vergelijking met baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16.
    Week 16.
    E.5.2Secondary end point(s)
    • Infliximab serum concentration of Remsima™ 8 weeks after switch from Remicade by ELISA compared to baseline.
    • Antibody to infliximab (ATI) levels at 8 and 16 weeks after switch from Remicade by radio-immune assay (RIA) compared to baseline.
    • Disease activity:
    For CD: Harvey-Bradshaw Index (HBI), and serum C-reactive protein (CRP) at week 8 and 16 compared to baseline. Faecal calprotectin at week 16 compared to baseline.
    For UC: Simple Clinical Colitis Activity Index (SCCAI), and serum CRP at week 8 and 16 compared to baseline. Faecal calprotectin at week 16 compared to baseline.
    For RA: DAS-28 score and serum CRP at week 8 and 16 compared to baseline.
    • European Quality of Life-5 Dimensions (EQ-5D) score, overall and per disease group at week 16 compared to baseline.
    • Adverse events (AEs), serious adverse events (SAEs) and infusion reactions at week 8 and 16 compared to incidence and type of adverse drug reactions (ADR) of Remicade at baseline.
    • Infliximab serum concentratie van Remsima™ d.m.v. ELISA, 8 weken na de omschakeling van Remicade vergeleken met baseline.
    • Antilichamen tegen infliximab op 8 en 16 weken na de omschakeling van Remicade vergeleken met baseline.
    • Ziekte-activiteit:
    - Voor patiënten met CD: 'Harvey-Bradshaw Index' (HBI) en de concentratie C-reactief proteïne in serum op 8 en 16 weken vergeleken met baseline. De hoeveelheid calprotectine in de ontlasting op 16 weken vergeleken met baseline.
    - Voor CU: 'Simple Clinical Colitis Activity Index' (SCCAI) en de concentratie C-reactief proteïne in serum op 8 en 16 weken vergeleken met baseline. De hoeveelheid calprotectine in de ontlasting op 16 weken vergeleken met baseline.
    - Voor RA: 'Disease Activity Score' (DAS-28) en serum CRP op 8 en 16 weken vergeleken met baseline.
    • 'European Quality of Life-5 Dimensions (EQ-5D) score', totaal en per ziektegroep, op 16 weken vergeleken met baseline.
    • 'Adverse events' (AEs), 'serious adverse events (SAEs) en infusie gerelateerde reacties op 8 en 16 weken vergeleken met de incidentie en type 'adverse drug reactions' van Remicade op baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 8 and 16 weeks.
    Na week 8 en week 16.
    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 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) 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 Yes
    E.8.1.7.1Other trial design description
    De metingen uitgevoerd op baseline (Remicade) worden als referentie gebruikt.
    Baseline measurements of Remicade therapy are used as reference.
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Laatste visite van de laatste patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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) 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 156
    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.
    Geen.
    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 Decision2016-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
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