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    Summary
    EudraCT Number:2020-003874-30
    Sponsor's Protocol Code Number:MS700568_0158
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003874-30
    A.3Full title of the trial
    A 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial
    Studio di follow-up di 2 anni con l'obiettivo di valutare le funzioni cognitive e la qualità di vita correlata alla salute (health-related quality of life, HRQoL) in pazienti con sclerosi multipla recidivante (SMR) altamente attiva che hanno partecipato alla sperimentazione CLARIFY MS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose
    Funzioni cognitive e HRQoL in adulti con SMR altamente attiva a 3 e 4 anni dopo la dose iniziale di Mavenclad®
    A.3.2Name or abbreviated title of the trial where available
    CLARIFY MS Extension
    CLARIFY MS Extension
    A.4.1Sponsor's protocol code numberMS700568_0158
    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 Healthcare KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Healthcare KGaA
    B.5.2Functional name of contact pointNektaria Alexandri
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number004915114543196
    B.5.6E-mailnektaria.alexandri@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 - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 tablets
    D.3.2Product code [Not Applicable]
    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 INNCLADRIBINA
    D.3.9.2Current sponsor codeEMD 280922 - MSC1326724A
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Highly-active relapsing multiple sclerosis
    La sclerosi multipla recidivante (SMR) altamente attiva
    E.1.1.1Medical condition in easily understood language
    Multple sclerosis (MS)
    Sclerosi multipla (SM)
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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 cognitive impairment in participants with highly-active relapsing multiple sclerosis (RMS), having participated to the CLARIFY MS trial, at 4 years after initial dose of cladribine tablets
    Valutazione delle disfunzioni cognitive nei soggetti con sclerosi multipla recidivante (SMR) altamente attiva che hanno partecipato alla sperimentazione CLARIFY MS, 4 anni dopo la dose iniziale di cladribina in compresse
    E.2.2Secondary objectives of the trial
    To assess health related quality of life (HRQoL) in participants with highly-active RMS, having participated in the CLARIFY MS trial, at 4 years after initial dose of cladribine tablets
    Valutazione della qualità di vita correlata alla salute (HRQoL) nei soggetti con SMR altamente attiva che hanno partecipato alla sperimentazione CLARIFY MS, 4 anni dopo la dose iniziale di cladribina in compresse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants having participated in the CLARIFY MS trial, who:
    a. Have at least CLARIFY MS Baseline data on SDMT;
    b. Received at least a single dose of cladribine tablets in the CLARIFY MS trial; and
    c. Completed the Final Study Visit (M24) of the CLARIFY MS trial.
    2. Capable of giving signed informed consent, which includes compliance
    with the requirements and restrictions listed in the informed consent
    form (ICF) and this protocol.
    1. Partecipanti che hanno partecipato allo studio CLARIFY MS, che:
    a. Hanno almeno CLARIFY MS Baseline data su SDMT;
    b. Hanno ricevuto almeno una singola dose di compresse di cladribina nello studio CLARIFY MS; e
    c. Hanno completato la visita finale dello studio (M24) dello studio CLARIFY MS.
    2. Capace di dare il consenso informato firmato, che include la conformità con i requisiti e le restrizioni elencati nel consenso informato (ICF) e questo protocollo.
    E.4Principal exclusion criteria
    1. Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study.
    2. Participation in other studies/trials.
    1. Il Partecipante è considerato dallo Sperimentatore e dallo Sponsor, per qualsiasi motivo, un candidato inadatto per lo studio.
    2. Partecipazione ad altri studi / sperimentazioni.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants with no or minimal decline in cognitive function, defined as an improved or stable Symbol Digit Modalities Test (SDMT) scorea or a decline of 4 points or less in the SDMT score, at 4 years after initial dose of cladribine tablets (M48) compared to SDMT score prior to initial dose of cladribine tablets (CLARIFY MS Baseline)
    Percentuale di partecipanti con declino minimo o nullo delle funzioni cognitive definito sulla base del Symbol Digit Modalities Test (SDMT) in presenza di un punteggio SDMT migliore, stabile o con una riduzione di 4 punti, 4 anni dopo la dose iniziale di cladribina in compresse (M48), rispetto al punteggio SDMT prima della dose iniziale di cladribina in compresse (baseline sperimentazione CLARIFY MS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    CLARIFY end of study visit defined as 48 months (+/-28 days) after initial Mavenclad dose, or early discontinuation visit
    CLARIFY la visita di fine studio definita come 48 mesi (+/- 28 giorni) dopo Dose iniziale di Mavenclad o visita di sospensione anticipata
    E.5.2Secondary end point(s)
    • Change in HRQoL as measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) physical and mental health scores at 4 years after initial dose of cladribine tablets (M48) compared to prior to initial dose of cladribine tablets (CLARIFY MS Baseline)
    • Change in HRQoL as measured by MSQoL-54 physical and mental health scores at 4 years after initial dose of cladribine tablets (M48) compared to M24
    • Cambiamenti nella HRQoL misurati in base ai punteggi relativi alla salute fisica e mentale risultanti dal questionario Multiple Sclerosis Quality of Life-54 (MSQoL-54), 4 anni dopo la dose iniziale di cladribina in compresse (M48), rispetto al punteggio prima della dose iniziale di cladribina in compresse (baseline sperimentazione CLARIFY MS)
    • Cambiamenti nella HRQoL misurati in base ai punteggi MSQoL-54 per salute fisica e mentale, 4 anni dopo la dose iniziale di cladribina in compresse (M48), rispetto alla visita della M24
    E.5.2.1Timepoint(s) of evaluation of this end point
    CLARIFY visit 1, defined as 36 months (+/-28 days) after initial Mavenclad dose
    CLARIFY end of study visit defined as 48 months (+/-28 days) after initial Mavenclad dose, or early discontinuation visit
    CLARIFY visita 1, definita come 36 mesi (+/- 28 giorni) dopo la dose iniziale di Mavenclad.
    CLARIFY visita di fine studio definita come 48 mesi (+/- 28 giorni) dopo la dose iniziale di Mavenclad o visita di interruzione anticipata.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    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
    Ambispettico;dati da pazienti partecipanti a sperimentazioni precedenti. Nessun IMP durante lo studi
    Ambispective; data from patients participating to past trials. No IMP treatment during this study. T
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years2
    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: 318
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-05-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state81
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 320
    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 Decision2021-01-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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