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    Summary
    EudraCT Number:2016-003138-26
    Sponsor's Protocol Code Number:58746
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-08-08
    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 number2016-003138-26
    A.3Full title of the trial
    Influenza vaccination in patients with Myasthenia Gravis
    Influenza vaccinatie in patienten met Myasthenia Gravis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Flu vaccine in patients with Myasthenia Gravis
    De griepprik in patienten met Myasthenia Gravis
    A.3.2Name or abbreviated title of the trial where available
    Influenza vaccine in Myasthenia Gravis
    Influenza vaccinatie in Myasthenia Gravis
    A.4.1Sponsor's protocol code number58746
    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 SponsorLUMC
    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 supportLUMC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLUMC
    B.5.2Functional name of contact pointInfluenza study contact
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0071315262118
    B.5.5Fax number0071315266671
    B.5.6E-mailmyasthenie@lumc.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 Influenza vaccine
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameInfluenza vaccine
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myasthenia gravis
    Myasthenia gravis
    E.1.1.1Medical condition in easily understood language
    Myasthenia gravis
    Myasthenia gravis
    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 this study is to investigate the effectiveness of the humeral immune response after influenza revaccination in patients with MG with acetylcholine antibodies (AChR MG).
    Het hoofddoel van deze studie is het onderzoeken van de effectiviteit van de humorale immuunrespons na een influenza vaccinatie in patiënten met MG met antistoffen tegen de acetylcholinereceptor.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine if vaccination induces immunological or clinical exacerbation in patients with AChR MG.
    Secundair doel is het vaststellen of een vaccinatie een immunologische en/of klinische exacerbatie geeft in patiënten met deze vorm van MG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged above 18 years at the time of the injection.
    2. Patient with ocular or generalized AChR MG and
    3. A positive serologic test for AChR antibodies > 0.5 nmol/l in the past
    4. Patient with prednisone dose lower than 30mg and stable (dose +/- 5mg) during the 3 months before participation; other immunosuppressive should be stable/unchanged.
    5. A healthy control above 18 years at the time of injection with no immunosuppressive medication.
    1. Mannen en vrouwen van >18 jaar en ouder op het moment van de injectie
    2. Patienten met oculaire of gegeneraliseerde AChR MG en
    3. Een positieve serologie voor AChR-antistoffen >0.5 nmol/L in het verleden
    4. Patienten die prednison gebruiken, moeten een dosering <30mg gebruiken en stabiel zijn (+/- 5mg) gedurende de 3 maanden voor de injectie; overige immunosuppressiva moeten onveranderd zijn gedurende deze 3 maanden.
    5. Gezonde controles van 18 jaar en ouder op het moment van injectie, die geen immunosuppressiva gebruiken.
    E.4Principal exclusion criteria
    1. MG patients with a severe form of MG (Grade 4 or 5 based on MGFA classification).
    2. Myasthenic crisis in the last 3 months
    3. Presence of a thymoma.
    4. Planned thymectomy during the study period or within 12 months prior of the tetanus toxoid booster immunization.
    5. Any confirmed or suspected immunosuppressive or immunodeficient condition not related to the treatment of MG, including human immunodeficiency virus (HIV) infection, or a family history of congenital or hereditary immunodeficiency.
    6. History or evidence of administration of immunoglobulins within 3 months prior to the tetanus revaccination.
    7. History or evidence of plasmapheresis within 3 months prior to the tetanus revaccination.
    8. At high risk for aspiration.
    9. Pulmonary: forced vital capacity reduced to less than 70% of predicted capacity.
    10. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
    11. History of relevant chronic degenerative, psychiatric, or neurological disorder other than MG.
    12. Severe hepatic, renal or cardiac insufficiency.
    13. Major congenital defects or serious chronic illness other than MG.
    14. Pregnancy or desire to become pregnant during the study.
    15. Use of vitamin-K antagonist or new anti-coagulants (NOACS)
    16. The patient is unable to fill out the study questionnaires or be interviewed in Dutch, or is unable to undergo the tests needed for the study, or is unable to give informed consent for participation in the study.
    17. The investigator can exclude patients for this trial which are deemed not suitable for any reason.
    1. MG patiënten met een ernstige vorm van MG (graad 4 of 5 op basis van de MGFA classificatie)
    2. Myasthene crisis in de afgelopen 3 maanden.
    3. Aanwezigheid van een thymoom.
    4. Een geplande thymectomy gedurende de trial of binnen 12 maanden voorafgaand aan de vaccinatie met het influenza vaccin.
    5. Een bevestigde of verdenking op een immunosuppressieve of immunodeficiente aandoening, niet gerelateerd aan MG, zoals het HIV virus of een familiare voorgeschiedenis van een aangeboren of erfelijke immunodeficientie.
    6. Toediening van immunoglobulines 3 maanden voor de influenza vaccinatie.
    7. Toepassing van plasmaferese in de 3 maanden voor de influenza vaccinatie.
    8. Verhoogd risico op aspiratie.
    9. Verminderde vitale capaciteit, minder dan 70% van verwacht.
    10. Allergische ziekten die waarschijnlijk uitgelokt kunnen worden door de vaccinatie.
    11. Voorgeschiedenis van relevante, chronische degeneratieve, psychiatrische of neurologische aandoeningen anders dan MG.
    12. Ernstige lever-, nier of cardiale insufficientie.
    13. Ernstige aangeboren congenitale defecten of ernstige ziekte anders dan MG.
    14. Zwangerschap of een zwangerschapswens gedurende de studie.
    15. Gebruik van vitamine K-antagonisten of NOACs (nieuwe anti-coagulantia)
    16. De proefpersoon is niet in staat om een vragenlijst of interview in het Nederlands te voltooien of is niet in staat om informed consent te geven.
    17. De onderzoeker kan patienten excluderen die niet geschikt lijken voor een bepaalde reden.
    E.5 End points
    E.5.1Primary end point(s)
    Change in total influenza specific serum IgG titer in patients with AChR MG
    Verandering van het totaal influenza specifieke IgG in patienten met AChR MG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 weken
    E.5.2Secondary end point(s)
    Clinical relevant change in clinical scores (2 points for MG-ADL, 3 points for the QMG and the MG composite). Approaches to look at the clinic:
    1. The mean change of the test scores of the two groups (A+B vs. C+ D)
    2. The number of patients who show a clinical relevant test on one of the tests en
    compare this number of patients between the groups.
    3. If a patient shows a clinical relevant change on a test, to look whether this is also
    on the other tests en compare this number of patients between the two groups (A+B vs C+D).

    - Change in autoimmune antibody titers against AChR.

    - The effect of the pre-study medication (use of immunosuppressive medication) at the immunological response.
    1) Een klinisch relevante verandering van de klinische scores (2 punten voor de MG-ADL, 3 punten voor de QMG of de MG composite). Manieren om hiernaar te kijken:
    1. De gemiddelde verandering van de scores vergelijken tussen de twee groepen
    2. Het aantal patiënten dat een klinisch relevante verandering laat zien vergelijken tussen de groepen.
    3. Als een patiënt een klinisch relevante verandering laat zien op 1 test, kijken of deze patiënt dat ook op de overige testen laat zien en dit aantal patiënten vergelijken tussen de twee groepen.

    2) Verandering van de antistoffen tegen de AChR

    3) Het effect van pre-studie medicatie op de immunologische respons (immunosuppressiva).
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks and 3 months
    4 weken en 3 maanden
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    End of trial is at 3 months after the influenza vaccine, done by an telephonic interview
    Einde van de studie is 3 maanden na de influenza vaccinatie, telefonische vragenlijst afname.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state96
    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)
    Not applicable
    Not applicable
    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 Decision2016-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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