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    Summary
    EudraCT Number:2020-001710-37
    Sponsor's Protocol Code Number:NL73727
    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:2021-01-29
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-001710-37
    A.3Full title of the trial
    Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial.
    Intraveneuze immunoglobulines als aanvullende behandeling bij pas gediagnosticeerde myositis: sneller en beter herstel?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial.
    Intraveneuze immunoglobulines als aanvullende behandeling bij pas gediagnosticeerde myositis: sneller en beter herstel?
    A.3.2Name or abbreviated title of the trial where available
    IVIG in myositis: TIME IS MUSCLE
    IVIG in myositis: TIME IS MUSCLE
    A.4.1Sponsor's protocol code numberNL73727
    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 SponsorAcademisch Medisch Centrum
    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 supportSanquin Plasma Products B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademisch Medisch Centrum
    B.5.2Functional name of contact pointJoost Raaphorst
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205669111
    B.5.6E-mailj.raaphorst@amsterdamumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Nanogam
    D.2.1.1.2Name of the Marketing Authorisation holderSanquin Plasma Products B.V., Amsterdam, The Netherlands
    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 nameNanogam
    D.3.4Pharmaceutical form 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 INNHuman normal immunoglobulin
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN (IV)
    D.3.9.4EV Substance CodeSUB12041MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Sodium Chloride 0.9%
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter B.V.
    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 nameSodium Chloride 0.9%
    D.3.2Product code RVG 56083
    D.3.4Pharmaceutical form Solution for 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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    idiopathic inflammatory myopathies
    Idiopathische inflammatoire myopathieën
    E.1.1.1Medical condition in easily understood language
    auto-immune inflammation/ disease of the muscles
    auto-immuun inflammatie/ ziekte van de spieren
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 primary aim is to examine whether early addition of IVIg to standard treatment with prednisone in patients with newly diagnosed myositis leads to superior clinical outcome after 8 weeks.
    Het primaire doel is om te onderzoeken of IVIG als toevoeging op de standaardbehandeling met prednison, in patienten met nieuw gediagnosticeerde myositis leidt tot een betere klinische uitkomst na 8 weken.
    E.2.2Secondary objectives of the trial
    Our secondary aims are to examine the effect of the intervention on health-related quality of life, physical activity and a biomarker (muscle MRI) on the short and longer term.
    Het secundaire doel is om het effect van interventie te meten op gezondheid gerelateerde kwaliteit van leven, lichamelijke activiteit en een biomarker (spier MRI) op de korte en lange termijn.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients (18-80 years) with idiopathic inflammatory myopathy (IIM), according to diagnostic criteria:
    - Dermatomyositis
    - Non-specific/overlap myositis including antisynthetase syndrome; formerly known as polymyositis
    - Immune mediated necrotizing myopathy
    • Disease duration < 12 months
    • Muscle biopsy including immunostaining (except in patients with characteristic skin features consistent with a diagnosis of dermatomyositis)
    • Analysis of myositis specific antibodies
    • Signed informed consent
    • Volwassen patienten (18-80 jaar) met idiopathische inflammatoire myopathieën (IIM), volgens de geldende diagnostische criteria:
    - Dermatomyositis
    - Non-specifieke/overlap myositis waaronder het antisynthetase syndroom; voorheen bekend als polymyositis
    - Immuun gemedieerde necrotiserende myopathie
    • Ziekte duur < 12 maanden
    • Spierbiopt inclusief immunohistochemische kleuring (behalve in patienten met karakteristieke huidafwijkingen passend bij de diagnose dermatomyositis)
    • Analyse van myositisspecifieke autoantistoffen
    • Ondertekend informed consent
    E.4Principal exclusion criteria
    • Disease duration > 12 months
    • Immunosuppressive medication within the last 12 months (azathioprine, methotrexate plasmapheresis, IVIg, biologicals). We will allow prednisone dosed as follows:
    - Daily dose 20 mg or lower, used for two weeks or less
    - Daily dose higher than 20 mg, used for 1 week or less
    - No evident clinical response
    • Related to IVIG:
    - History of thrombotic episodes within 10 years prior to enrolment
    - Known allergic reactions or other severe reactions to any blood-derived product
    - Known IgA deficiency and IgA serum antibodies
    - Pregnancy (wish)
    • Conditions that are likely to interfere with:
    - Compliance (legal incompetent and/or incapacitated patients are excluded), or,
    - Evaluation of efficacy (e.g. due to severe pre-existing disability as a result of any other disease than myositis or due to language barrier)
    • Ziekte duur > 12 maanden
    • Immuunsysteem onderdrukkende medicatie in de laatste 12 maanden voorafgaand aan inclusie (azathioprine, methotrexaat, plasmaferese, IVIg, biologicals). Prednison gebruik zal worden getolereerd indien:
    - Dagelijkse dosis 20mg of lager, gedurende maximaal 2 weken
    - Dagelijkse dosis hoger dan 20mg, gedurende maximaal 1 week
    - Geen evidente klinische respons
    • Gerelateerd aan IVIG:
    - Voorgeschiedenis van thrombotische episodes in de 10 jaar voorafgaand aan inclusie
    - Bekende allergische reacties of andere ernstige reacties op uit bloed afgeleide producten
    - Bekende IgA deficientie en IgA antistoffen
    - Zwangerschap of wens tot zwangerschap
    • Omstandigheden met een aanneemlijk risico te interfereren met:
    - Compliance (personen die wettelijk onbekwaam zijn of feitelijk bekwaamheid missen zijn geexcludeerd van deze studie), of,
    - Evaluatie van de effectiviteit van interventie (b.v. vanwege ernstige pre-existente invaliditeit als gevolg van een ziekte anders dan myositis, of een taalbarriere)
    E.5 End points
    E.5.1Primary end point(s)
    The Total Improvement Score (TIS) of the myositis response criteria after 8 weeks compared to t=0, before treatment.

    Total Improvement Score is based on 6 validated core set measures which each determine disease activity as defined by the International Myositis Assessment and Clinical Studies (IMACS) group. The core set measures are differentially weighted:

    1. doctor’s global activity assessment - 20%
    2. patient’s global activity assessment - 10%
    3. manual muscle strength testing - 32.5%
    4. physical functioning (health assessment questionnaire) – 10%
    5. serum creatine kinase activity - 7.5%
    6. extramuscular activity assessment (e.g. lung disease, skin manifestation) – 20%

    TIS ranges between 0 and 100 and corresponds to a degree of improvement, with higher scores corresponding to a greater degree of improvement. Cut-offs are based on clinical criteria of the American College of Rheumatology/European League Against Rheumatism: minimal, moderate and major improvement have been defined as TIS ≥ 20; ≥ 40 and ≥60 points, respectively.
    Total Improvement Score (TIS) op de myositis response criteria zoals gedefinieerd door de International Myositis Assessment and Clinical Studies (IMACS) group, na 8 weken, vergeleken met week 0 voorafgaand aan behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    TIS will be assessed at t=0 and after 4, 8 , 12 and 26 weeks.
    TIS wordt geëvalueerd op t=0 en na 4, 8 , 12 en 26 weken.
    E.5.2Secondary end point(s)
    1. Health related quality of life (HR-QoL) assessed with EuroQol Group Health Questionnaire (EQ5D).
    2. Physical functioning measured by accelerometry.
    3. Biomarker: muscle hyperintensities on total body MRI (T1 and T2/STIR) as a marker of inflammation.
    4. Each of the core set measures of the IMACS TIS: doctor’s global activity assessment, patient’s global activity assessment, manual muscle strength testing, physical functioning, serum creatine kinase activity, extramuscular activity assessment.
    5. Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) in the subgroup of patients with dermatomyositis.
    1. Gezondheid gerelateerde kwaliteit van leven (GKvL) zoals gemeten door de EuroQol Group Health Questionnaire (EQ5D).
    2. Lichamelijke activiteit gemeten door accelerometrie.
    3. Biomarker: spier hyperintensiteit op total body MRI (T1 and T2/STIR) als maat voor inflammatie.
    4. Elk van de 6 IMACS TIS ’core set measures'.
    5. Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) in de subgroep van patienten met dermatomyositis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. HR-QoL assessed with EQ5D will be measured at baseline and after 4, 8, 12 and 26 weeks.
    2. Physical functioning measured by accelerometry will be collected daily from baseline during the period of 8 weeks, and for a second term after 22 weeks during the period of 1 month.
    3. Biomarker: muscle hyperintensities on total body MRI (T1 and T2/STIR) will be measured at baseline, after 8 and after 26 weeks.
    4. Each of the cores set measures of the IMACS TIS will be measured at baseline and after 4, 8, 12 and 26 weeks.
    5. Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) will be measured at baseline and after 4, 8, 12 and 26 weeks (in the subgroup of patients with dermatomyositis).
    1. Gezondheid gerelateerde kwaliteit van leven (GKvL) zoals gemeten door de EuroQol Group Health Questionnaire (EQ5D): t=0 en na 4, 8, 12 en 26 weken.
    2. Lichamelijke activiteit gemeten door accelerometrie: vanaf t=0 gedurende 8 weken, en na 22 weken gedurende 4 weken.
    3. Biomarker: spier hyperintensiteit op total body MRI (T1 and T2/STIR): t=0 en na 8 en 26 weken.
    4. Elk van de 6 IMACS TIS ’core set measures': t=0 en na 4, 8, 12 en 26 weken.
    5. Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI): t=0 en na 4, 8, 12 en 26 weken (in de subgroep van patienten met dermatomyositis).
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    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, or in case of unacceptable preliminary results, defined as:
    • 100% SAEs rate in the first 4 inclusions (≥4 study subjects)
    • ≥80% SAEs rate in the first 5 inclusions (≥4 study subjects)
    • ≥60% SAEs rate in the first 6 inclusions (≥4 study subjects)
    • ≥50% SAEs rate after the first 7 inclusions (≥4 study subjects)
    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 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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state48
    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)
    Participants will be followed and treated to the discretion of the treating physician ( = standard care).
    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 Decision2021-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-27
    P. End of Trial
    P.End of Trial StatusOngoing
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