Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44238   clinical trials with a EudraCT protocol, of which   7338   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2017-002632-17
    Sponsor's Protocol Code Number:MS700568_0021
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-07
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2017-002632-17
    A.3Full title of the trial
    A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
    Étude prospective de 2 ans destinée à évaluer la qualité de vie liée à la santé chez des patients présentant une sclérose en plaques récidivante hautement active traités par Mavenclad®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Quality of Life Study for People with Relapsing Multiple Sclerosis
    Etude sur la qualité de vie liée à la santé chez des personnes présentant une sclérose en plaques récidivante
    A.4.1Sponsor's protocol code numberMS700568_0021
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.com
    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 Mavenclad®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono Europe Limited
    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 nameCladribine
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLADRIBINE
    D.3.9.1CAS number 4291-63-8
    D.3.9.2Current sponsor codeEMD280922
    D.3.9.3Other descriptive name2-chloro-2'-deoxyadenosine (2-CdA)
    D.3.9.4EV Substance CodeSUB06635MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing multiple sclerosis
    sclérose en plaques récidivante
    E.1.1.1Medical condition in easily understood language
    Relapsing multiple sclerosis
    sclérose en plaques récidivante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the health related quality of life (HRQoL) through the MSQOL-54 scale in relapsing multiple sclerosis subjects treated with Mavenclad® for 2 years (24 months)
    Évaluer la qualité de vie liée à la santé (HRQoL) au moyen de l’échelle MSQoL-54 chez des patients atteints de sclérose en plaques récidivante (SPR) hautement active traités par Mavenclad® pendant 2 ans (24 mois)
    E.2.2Secondary objectives of the trial
    To assess treatment satisfaction through the TSQM v1.4 questionnaire in relapsing multiple sclerosis subjects at 6 months of treatment
    Évaluer la satisfaction à l’égard du traitement, au moyen du questionnaire TSQM v1.4 chez les patients atteints de sclérose en plaques récidivante, après 6 mois de traitement par Mavenclad®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects ≥ 18 years old;
    • Highly active RMS as defined by:
    - One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs);
    - Two or more relapses in the previous year, whether on DMD treatment or not;
    • EDSS score ≤5.0
    Hommes ou femmes âgé(e)s de 18 ans
    • SPR hautement active, définie par :
    - Une rechute au cours de l’année précédente et au moins une lésion T1 Gd+ ou 9 lésions T2, pendant le traitement par d’autres médicaments modificateurs de la maladie (disease modifying drugs, DMD);
    - Au moins deux rechutes au cours de l’année précédente, que ce soit sous traitement par DMD ou non;
    • Score EDSS ≤5,0
    E.4Principal exclusion criteria
    • Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM)
    • Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
    • Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids
    • History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
    • Presence of PML in MRI
    • Active malignancy and history of malignancy
    • Hypersensitivity to Mavenclad® or to any of the excipients listed in the SmPC
    • Presence or suspect of PML or other (than MS) major Central Nervous System disease clinically diagnosed or evidences in screening MRI
    • Moderate or severe renal impairment (creatinine clearance <60 mL/min)
    • Sérologie positive vis-à-vis de l’hépatite C ou de l’hépatite B (présence d’antigène HBs) et/ou présence d’immunoglobulines G (IgG) et/ou d’immunoglobulines M (IgM)
    • Présence ou antécédents d’une immunodéficience, y compris sérologie positive vis-à-vis du virus de l’immunodéficience humaine (VIH)
    • Traitement immunosuppresseur ou myélosuppresseur en cours, p. ex. par anticorps monoclonaux, méthotrexate, cyclophosphamide, cyclosporine ou azathioprine, ou traitement chronique par corticoïdes
    • Antécédents de tuberculose, présence d’une tuberculose active, ou tuberculose latente
    • Présence de LMP à l’IRM
    • Tumeur maligne active ou antécédent de tumeur
    • Intolérance au Mavenclad® ou à l'un des excipients listés dans le RCP
    • Présence ou suspicion de LMP ou d'une autre maladie du système nerveux central (autre que SP) diagnostiqué ou détectée par IRM au screening
    • Insuffisance rénal modérée ou sévère (clairance de la créatinine <60 mL/min)
    E.5 End points
    E.5.1Primary end point(s)
    Changes in MSQoL-54 at 24 months compared to baseline
    Évolution du score MSQoL-54 à 24 mois par rapport à T0
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 24 months compared to baseline
    à 24 mois par rapport à T0
    E.5.2Secondary end point(s)
    Treatment satisfaction assessed by TSQM v1.4 at 6 months
    Satisfaction à l’égard du traitement, évaluée d’après le score TSQM v1.4 à 6 mois
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6 months
    à 6 mois
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Czech Republic
    Denmark
    Finland
    France
    Greece
    Hungary
    Israel
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 trial is defined as the last subject’s End of Trial visit.
    La fin de l'étude est définie comme la visite de fin d'étude du dernier patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 445
    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 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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 406
    F.4.2.2In the whole clinical trial 445
    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)
    The Sponsor will not provide any additional care to subjects after they leave the trial because such care should not differ from what is normally expected for subjects with Relapsing Multiple Sclerosis.

    Upon completion of study, subjects will be offered the opportunity of enrolling into an Extension study that may be planned by the Sponsor, for a further 2 years (i.e., until 4 years from first treatment year course). A separate protocol will be followed for the Extension study.
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA