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    Summary
    EudraCT Number:2013-004988-32
    Sponsor's Protocol Code Number:NL46993.078.13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-004988-32
    A.3Full title of the trial
    Rotterdam Observational Study in CIDP of Pharmacokinetics of Intravenous γ-globulin
    Rotterdamse observationele studie bij CIDP naar de farmacokinetiek van
    intraveneuze γ-globuline
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetics of IVIg treatment in patients with CIDP
    Farmacokinetiek van IVIg behandeling bij patiënten met CIDP
    A.3.2Name or abbreviated title of the trial where available
    ROCKY-1
    A.4.1Sponsor's protocol code numberNL46993.078.13
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportPrinses Beatrix Spierfonds
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointGBS workgroup Erasmus MC
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 50
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3000 CA PO 2040
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310107043430
    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 Kiovig
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter AG
    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.3.1Product nameKiovig
    D.3.4Pharmaceutical form 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 Yes
    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
    Chronic Inflammatory Demyelinating Polyneuropathy
    Chronische Inflammatoire Demyeliniserende Polyneuropathie
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory dyemyelinating polyneuropathy (NB no common lay-term in use).
    Chronische inflammatoire demyeliniserende polyneuropathie (geen lekenterm, n.b. er is geen gangbare lekenterm in omloop)
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to determine the PK and PD of IVIg during maintenance treatment in
    patients with CIDP. These data will be used to conduct a NONMEM analysis in relation to the dosage,
    frequency and batch of IVIg used.
    Deze studie beoogd met behulp van uitgebreide farmacokinetische en –dynamische data een model te ontwikkelen
    (via NONMEM) welke ons meer inzicht geeft in het farmacologische profiel van IVIg bij CIDP patiënten en tevens zorgdraagt voor een “evidence based” mogelijkheid om tot een optimaal individueel doseringsschema te
    komen.
    E.2.2Secondary objectives of the trial
    To investigate which factors influence the pharmacological profile of IVIg, including demographic, clinical and genetic factors.
    Factoren in kaart brengen welke het farmacologisch profiel van IVIg beïnvloeden, er wordt o.a. gekeken naar demografische, klinische en genetische factoren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of CIDP made by a consultant neurologist, fulfilling the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) clinical diagnostic criteria.
    2. EMG findings compatible with the diagnosis CIDP showing peripheral nerve demyelination at least once during their illness. These findings should preferentially fulfill the electrodiagnostic criteria proposed by the European Inflammatory
    Neuropathy Cause and Treatment (INCAT) or EFNS/PNS.
    3. Age ≥18 years.
    4. Patients require to be on maintenance treatment with IVIg.
    5. Signed informed consent by the patient.
    1. Diagnose van CIDP door een Neuroloog volgens de klinisch diagnostische criteria
    opgesteld door de European Federation of Neurological Societies/Peripheral Nerve
    Society (EFNS/PNS).
    2. EMG bevindingen welke overeenkomen met de diagnose CIDP en ten minste één
    maal gedurende de ziekte demyelinisatie van de perifere zenuwen toont. Deze
    bevindingen moeten voldoen aan de daarvoor opgestelde criteria door de INCAT
    en/of EFNS/PNS.
    3. Leeftijd van 18 jaar of ouder.
    4. Patiënten dienen IVIg als onderhoudstherapie te hebben.
    5. Getekend informed consent door de patient
    E.4Principal exclusion criteria
    1. Known IgA deficiency or known allergic reaction to IVIg.
    2. Known hereditary neuropathy or severe concomitant diseases such as HIV infection, Lyme disease, chronic active hepatitis, congestive heart failure, systemic lupus erythematosus, drug or toxin induced neuropathy, vasculitis, and
    malignancies.
    3. Multifocal motor neuropathy (MMN), fulfilling the European Federation of Neurological Societies /Peripheral Nerve Society criteria.
    4. IgM paraprotein with anti-myelin-associated glycoprotein (MAG) antibodies.
    5. Atypical CIDP with pure sensory or persistent unifocal impairment or significant central nervous system involvement.
    6. Severe known abnormalities in liver, kidney function or serum glucose level.
    7. Concomitant treatment with prednisone.
    1. Bekende IgA deficiëntie of allergische reactie in de voorgeschiedenis tegen IVIg.
    2. Bekende erfelijke neuropathie of ernstige bijkomende ziekten zoals: HIV, ziekte van Lyme, actieve chronische hepatitis, congestief hartfalen, systemische lupus erythematodes, neuropathie geïnduceerd door medicatie of toxines, vasculitis, en maligniteiten.
    3. De diagnose van multifocale motore neuropathie (MMN) volgende de daarvoor opgestelde criteria door de EFNS/PNS.
    4. IgM paraproteïnen met de aanwezigheid van anti-MAG antilichamen.
    5. Atypische CIDP met enkel betrokkenheid van het sensorisch systeem of persisterende unifocale betrokkenheid of betrokkenheid van het centrale zenuwstelsel.
    6. Bekende ernstige lever- en/of nieraandoeningen, of een ernstig verstoord serum glucose spiegel.
    7. Gelijktijdige behandeling met prednison.
    E.5 End points
    E.5.1Primary end point(s)
    Serum IgG levels determined over the duration of two subsequent IVIg courses at standardized time points,
    before and after infusion.
    IgG (immunoglobuline G) spiegels gedurende twee opeenvolgende kuren met IVIg, voor en na behandeling, tijdens een aantal tijdspunten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be drawn at multiple time points during two subsequent IVIg courses, including (1) 5 minutes before start of IVIg, treatment, (2) 15 minutes after finishing IVIg treatment, (3) 2 hours after IVIg, (4) 24 hours after, (5) 2 days, (6) 7 days, (7) 14 days and in case of a treatment interval of more than 3 weeks; (8) 21 days after IVIg. Proposed time points are not entirely fixed and the definitive schedule will be in consultation with the patient, to accommodate the sampling times as much as possible to the wishes of the patient. Furthermore, some patients have a treatment interval of 2 weeks or less. Time points will then be adjusted accordingly.
    De bloedmonsters worden afgenomen op meerdere tijdspunten gedurende twee opeenvolgende IVIg kuren. Deze tijdspunten gedurende één kuur zijn: (1) 5 minuten voor toediening van IVIg via het infuus, (2) 15 minuten na de IVIg kuur via het infuus, (3) 2 uur na de IVIg via het infuus, (4) 24 uur na, (5) 2 dagen na, (6) 7 dagen na en (7) 14 dagen na het IVIg infuus. Indien de 2e opeenvolgende kuur volgt na meer dan 3 weken (minderheid van de patiënten) wordt er nog een additioneel monster afgenomen na 21 dagen (8). Indien de 2e opeenvolgende kuur volgt binnen 2 weken worden de tijdspunten daarop aangepast. Deze voorgestelde tijdspunten zijn in bepaalde mate flexibel om zoveel mogelijk tegemoet te komen aan de wensen van de patiënt.
    E.5.2Secondary end point(s)
    Immunological parameters: Serum levels of IgG subclasses, IgG glycoforms, IgG allotypes and genetic polymorphisms involved in IgG metabolism (including polymorphisms in the IgG Fc-receptors). Albumin, cytokines (e.g. type I interferon),
    peripheral blood leukocytes and liver function parameters.
    Clinical parameters: Clinical factors for disease severity and endpoints, including hand grip strength
    (Vigorimeter) and questionnaires (R-ODS en R-FSS).
    Lab bepalingen: Serum spiegels van de IgG subklassen en glycosylering. Bepalen van de IgG allotype en genetische polymorfismen betrokken bij IgG metabolisme (IgG Fc-receptoren). Serum spiegel van albumine, cytokinen (bijv. type 1 interferon), perifere bloed leukocyten (bijv. plasmablasten) en lever functie parameters.
    Klinische parameters: Klinische maten voor ernst van de ziekte o.a. de handknijpkracht en vragenlijsten (R-ODS en R-FSS).
    E.5.2.1Timepoint(s) of evaluation of this end point
    All immunological parameters will be assessed via the samples collected under the primary end point.
    Clinical parameters will be assessed shortly before (hand grip strength) and during the two subsequent IVIg infusions (questionnaires) as well as at 7 and 14 days post IVIg (hand grip strength).
    Alle laboratorium bepalingen worden gedaan aan de hand van het materiaal verkregen voor het primaire eind punt van deze studie.
    De klinische parameters worden afgenomen kort voor (handknijpkracht) en tijdens de twee opeenvolgende IVIg behandelingen (vragenlijsten), tevens wordt er op dag 7 en 14 na de IVIg behandeling de handknijpkracht beoordeelt.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    NB Observationele studie: het huidige behandelschema met IVIg van de patiënt wordt niet aangepast.
    NB Observational study: no alterations will be made to patients’ current IVIg treatment regimen.
    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
    The end of the study is defined as the last patient’s last blood sample collection.
    Het einde van de studie is gedefinieerd als de laatste bloedafname bij de laatste patiënt.
    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 months
    E.8.9.1In the Member State concerned days
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state15
    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 Decision2014-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
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