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    Summary
    EudraCT Number:2016-003643-10
    Sponsor's Protocol Code Number:NAM
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2017-09-14
    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 number2016-003643-10
    A.3Full title of the trial
    Modulating regulatory T cell function in JIA with Vitamin B3 (nicotinamide) treatment
    Beinvloeden van regulatoire Tcel functie in JIA met Vitamine B3 (nicotinamide) behandeling
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety of additional treatment with Vitamin B3 in children with Juvenile Idiopathic Arthritis (JIA)
    Een studie naar de veiligheid van aanvullende behandeling van jeugdreuma met vitamine B3
    A.3.2Name or abbreviated title of the trial where available
    B-Vit in JIA
    A.4.1Sponsor's protocol code numberNAM
    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 SponsorUMC Utrecht
    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 supportUMC Utrecht- research fund
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointS.J.Vastert
    B.5.3 Address:
    B.5.3.1Street AddressLundlaan 6
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 EA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031887554339
    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 No
    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 namenicotinamide
    D.3.2Product code 98-92-0
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 Yes
    D.3.11.13.1Other medicinal product typeVitamin B3
    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
    Juvenile idiopathic arthritis (JIA)
    JIA
    E.1.1.1Medical condition in easily understood language
    Juvenile arthritis
    jeugdreuma
    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
    In this phase II trial essential information will be gained on safety, feasibility and tolerability of NAM as an additional treatment in JIA patients.
    In deze fase II trial zal essentiële informatie worden verkregen met betrekking tot veiligheid, verdragen van en haalbaarheid van NAM als aanvullende behandeling in JIA patiënten.
    E.2.2Secondary objectives of the trial
    Additionally, PK/PD data will we obtained which can be used to develop an optimal dosing scheme for a future phase III clinical trial. Next, preliminary data on the effect of NAM on the function of regulatory T cells will be acquired.
    In deze fase II trial zal essentiële informatie worden verkregen met betrekking tot veiligheid, verdragen van en haalbaarheid van NAM als aanvullende behandeling in JIA patiënten.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with a diagnosis of oligo-articular or poly-articular JIA with active disease in 1 or multiple joints and an indication for intra-articular corticosteroid injection.
    - Age between 4 to 18 years
    - At the moment of inclusion, not on non-biological DMARD (Methotrexate) treatment or on stable DMARD treatment (at least 3 months of stable Methotrexate use).
    - Patiënten met de diagnose oligo-articulaire of poly-articulaire JIA met actieve ziekte in 1 of meerdere gewrichten en een indicatie voor intra-articulaire corticosteroid injectie.
    - Leeftijd van 4 t/m 18 jaar
    - Op moment van inclusie geen gebruik van non-biological DMARD (Methotrexaat) of stabiel gebruik van Methotrexaat (minimaal 3 maanden).
    E.4Principal exclusion criteria
    - no informed consent possible by patient/parents or caregivers
    - participation in other interventional trials
    - Treatment with biological DMARD
    - Recently started treatment with non-biological DMARD (Methotrexate). Defined as treatment for a period less than 3 months.
    - Use of systemic corticosteroids
    - Relevant co morbidity: raised liver enzymes (>2x upper limit) and/or evidence of bone marrow failure (pancytopenia based upon full blood count).
    - Geen informed consent mogelijk
    - Deelname in andere interventie studies
    - Behandeling met biological DMARD
    - Recent gestarte behandeling met non-biological DMARD (Methotrexaat). Gedefinieerd als een periode van behandeling korter dan 3 maanden.
    - Relevante co-morbiditeit: verhoogde leverenzymen (meer dan 2x boven bovengrens van normaalwaarde) en/of aanwijzingen voor beenmergfalen (pancytopenie op basis van volledig bloedbeeld).
    E.5 End points
    E.5.1Primary end point(s)
    safety, feasibility and tolerability of nicotinamide treatment
    veiligheid, haalbaarheid, verdraagbaarheid van nicotinamide behandeling
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks, 6 weeks, 3 months and 6 months after start of treatment
    2wk, 6wk, 3mnd, 6mnd na start behandeling
    E.5.2Secondary end point(s)
    - PK/PD data
    - efficacy; to acquire preliminary data on the effect of nicotinamide on the function of regulatory T cells in vivo and in vitro by using surrogate parameters.
    -PK/PD data
    - Effectiviteit: eerste data verzamelen over effect van nicotinamide op de functie van regulatoire T-cellen in vitro en in vivo dmv immunologische parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 weeks, 6 weeks, 3 months and 6 months after start of treatment (time point 6 months only for efficacy outcome)
    2wk, 6wk, 3mnd, 6mnd na start behandeling (6 mnd alleen voor effectiviteit als uitkomstmaat)
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    first time in children with JIA , first trial on PK in children with nicotinamide
    Eerste keer bij kinderen met JIA en eerste studie naar PK data in kinderen
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 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
    when the safety of the trial participants is jeopardized or it becomes evident that no clear outcome would be obtained
    Wanneer de veiligheid van de studie participanten in gevaar komt or wanneer duidelijk wordt dat er de primaire uitkomstmaat niet bepaald kan worden door welke reden dan ook
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The study involves children under the age of 12 and are therefore not capable of giving informed consent. This will be done by parents/ legal representative according to good clinical practice guidelines (GCP)
    Bij de studie worden oa kinderen geïncludeerd onder de leeftijd van 12 jaar, welke geen informed consent kunnen geven. Om die reden worden ouders of wettelijk vertegenwoordig gevraagd toestemming te geven. Dit alles volgens de richtlijnen GCP
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    No different from normal treatment
    conform huidige behandeling bij JIA
    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 Decision2017-08-31
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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