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    Summary
    EudraCT Number:2019-000069-19
    Sponsor's Protocol Code Number:MS700568_0026
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-01
    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 number2019-000069-19
    A.3Full title of the trial
    Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials
    Valutazione degli esiti a lungo termine e della durata dell’effetto in seguito a trattamento con compresse di cladribina per la sclerosi multipla: uno studio esplorativo di fase IV, ambispettico di pazienti che hanno precedentemente partecipato alle sperimentazioni cliniche CLARITY/CLARITY-EXT e ORACLE MS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials
    Valutazione degli esiti a lungo termine e della durata dell’effetto in seguito a trattamento con compresse di cladribina per la sclerosi multipla: uno studio esplorativo di fase IV, ambispettico di pazienti che hanno precedentemente partecipato alle sperimentazioni cliniche CLARITY/CLARITY-EXT e ORACLE MS
    A.3.2Name or abbreviated title of the trial where available
    CLASSIC-MS
    CLASSIC-MS
    A.4.1Sponsor's protocol code numberMS700568_0026
    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 Str. 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post codeD-64293
    B.5.3.4CountryGermany
    B.5.4Telephone number00496151725200
    B.5.5Fax number00496151722000
    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 Europe B.V.
    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 nameCladribina
    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.3.9.2Current sponsor codecladibrin
    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
    Multiple Sclerosis
    Sclerosi Multipla
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi Multipla
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate long-term mobility after treatment with an investigational medicinal product (IMP; Cladribine Tablets or placebo) as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials.
    Valutare la mobilità a lungo termine a seguito del trattamento con un prodotto medicinale sperimentale (IMP; compresse di cladribina o placebo) nell’ambito delle sperimentazioni cliniche di fase III ORACLE MS e CLARITY/CLARITY-EXT.
    E.2.2Secondary objectives of the trial
    1. To assess the long-term disability status after treatment with IMP as part of the Phase III ORACLE MS and CLARITY/CLARITY-EXT clinical trials for the CLARITY/CLARITY-EXT and ORACLE MS populations.
    2. To evaluate differences in clinical characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
    MRI Sub-Study:
    3. To evaluate differences in magnetic resonance imaging (MRI) characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the
    CLARITY/CLARITY-EXT and ORACLE MS populations.
    1. Valutare lo stato di invalidità a lungo termine dopo il trattamento con l’IMP nell’ambito delle sperimentazioni cliniche di fase III ORACLE MS e CLARITY/CLARITY-EXT per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    2. Valutare le differenze nelle caratteristiche cliniche tra soggetti rispondenti a lungo termine e partecipanti allo studio richiedenti terapie alternative a seguito del trattamento con l’IMP per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    3. Valutare le differenze nelle caratteristiche della risonanza magnetica (RM) tra soggetti rispondenti a lungo termine e partecipanti allo studio richiedenti terapie alternative a seguito del trattamento con l’IMP per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Pharmacogenetics
    Version: 1.0
    Date: 28/01/2019
    Title: Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials
    Objectives: To evaluate differences in genetics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: MRI Sub-Study as integral part of the protocol v1.0 28.Jan.2019. To evaluate differences in magnetic resonance imaging (MRI) characteristics between long-term responders and study participants requiring alternate therapies following treatment with IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.

    Farmacogenetica
    Versione: 1.0
    Data: 28/01/2019
    Titolo: Valutazione degli esiti a lungo termine e della durata dell'effetto in seguito a trattamento con compresse di cladribina per la sclerosi multipla: uno studio esplorativo di fase IV, ambispettico di pazienti che hanno precedentemente partecipato alle sperimentazioni cliniche CLARITY/CLARITY-EXT e ORACLE MS
    Obiettivi: Valutare le differenze genetiche tra soggetti rispondenti a lungo termine e partecipanti allo studio richiedenti terapie alternative a seguito del trattamento con l’IMP per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sotto-Studio MRI come parte integrale del protocollo V1.0 28 gennaio 2019. Valutare le differenze nelle caratteristiche della risonanza magnetica (RM) tra soggetti rispondenti a lungo termine e partecipanti allo studio richiedenti terapie alternative a seguito del trattamento con l'IMP per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    E.3Principal inclusion criteria
    For Main Study and MRI Sub-Study:
    1. Patients with MS randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received = 1 course of IMP (Cladribine Tablets or placebo).
    or
    Patients with their FCDE randomised in ORACLE MS clinical trial who have received
    = 1 course of IMP (Cladribine Tablets or placebo).
    2. Patients can give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and this protocol.
    Per lo studio principale e sotto-studio MRI:
    1. Pazienti con SM randomizzati allo studio clinico CLARITY/CLARITY-EXT che abbiano ricevuto = 1 ciclo di medicinale sperimentale (IMP) (compresse di cladribina o placebo).
    oppure
    Pazienti con FCDE randomizzati allo studio clinico ORACLE MS = 1 ciclo di IMP (compresse di cladribina o placebo).
    2. Pazienti che sono in grado di fornire il consenso informato, firmato, che includa la conformità ai requisiti e alle restrizioni elencati nel modulo di consenso informato (ICF) e nel presente protocollo.
    E.4Principal exclusion criteria
    Main study:
    Any condition, including any uncontrolled disease state other than MS, that in the Investigator’s
    opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that
    could interfere with the study objectives, conduct, or evaluation.
    MRI-Substudy:
    a. Female study participants who are pregnant
    b. Patient is taking Cladribine Tablets as part of another study at the time of the start of
    this study (i.e. patients participating in a clinical trial or observational study but do not
    receive Cladribine Tablets as part of these studies are allowed to participate in the substudy).
    Studio Principale:
    Qualsiasi condizione, compreso qualsiasi stato patologico non controllato diverso dalla SM, che, nell’opinione dello sperimentatore costituisca un indebito rischio o una controindicazione alla partecipazione allo studio o che potrebbe interferire con gli obiettivi, la conduzione o la valutazione dello studio.

    Sotto-studio MRI:
    a. Partecipanti allo studio, femminili, che sono incinte
    b. Pazienti che assumono Cladribina compresse come parte di un altro studio al momento dell'inizio di questo studio (pazienti che partecipano ad una sperimentazione clinica o studio osservazionale, ma non ricevono Cladribina compresse come parte di questi studi sono ammessi a partecipare al sotto-studio).
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of study participants using a wheelchair (defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and
    transfers alone; up and about in wheelchair some 12 hours a day) the majority of the time in the 3 month prior to Study Visit 1 for the CLARITY/CLARITY-EXT and ORACLE MS populations, determined via:
    • Expanded Disability Status Scale (EDSS)
    score of 7.0 or higher (if available), or
    • Alternative clinical description data in medical records.
    Percentuale di partecipanti allo studio utilizzatori di carrozzina (definiti come partecipanti non in grado di deambulare all’incirca oltre 5 metri, anche con ausili, essenzialmente confinati in carrozzina; in grado di spingere e manovrare la carrozzina manuale e di effettuarvi spostamenti da soli; con una permanenza in carrozzina all’incirca pari a 12 ore al giorno) per la maggior parte del tempo nei 3 mesi precedenti la Visita 1 dello studio per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS, determinata tramite:
    • Punteggio della scala di invalidità espansa (EDSS) pari o superiore a 7.0 (se disponibile), oppure
    • Descrizione alternativa dei dati clinici nelle cartelle cliniche.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study visit 1
    Visita 1 dello studio
    E.5.2Secondary end point(s)
    1. Proportion of study participants with 3-month sustained EDSS of 6.0 or higher in the last year prior to enrolment (i.e.ambulatory disability consistent with EDSS on at least 2 clinic visits no less than 3 months apart) as determined by EDSS documentation or corresponding clinical description in medical records for the CLARITY/CLARITY-EXT and ORACLE MS populations
    2. Clinical characteristics of long-term responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and imaging outcomes until Year 4 or later following their last dose of IMP and who did not receive disease modifying treatment until Year 4 or later following their last dose of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last dose of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
    MRI Sub-Study:
    3. MRI characteristicsc at Study Visit 2 of longterm responders (defined as study participants who did not demonstrate any evidence of disease reactivation based on Investigator assessment of clinical and
    imaging outcomes until Year 4 or later following their last dose of IMP and who did not receive disease modifying treatment until Year 4 or later following their last dose of IMP) compared to those of other study participants who started on alternate therapy less than 4 years following their last dose of IMP for the CLARITY/CLARITY-EXT and ORACLE MS populations.
    1. Percentuale di partecipanti allo studio con punteggio EDSS sostenuto per 3 mesi pari o superiore a 6.0 nel corso dell’ultimo anno precedente l’arruolamento (ad es. invalidità deambulatoria coerente con un punteggio EDSS in occasione di almeno 2 visite in clinica eseguite a non meno di 3 mesi di distanza) come determinato mediante documentazione EDSS o corrispondente descrizione clinica riportata nelle cartelle cliniche per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    2. Caratteristiche clinichea alla Visita 1 dello studio dei soggetti rispondenti a lungo termine (definiti come partecipanti allo studio che non hanno dimostrato alcuna evidenza di riattivazione della malattia sulla base della valutazione dello sperimentatore degli esiti clinici e della diagnostica per immagini fino a 4 anni o più dopo la loro ultima doseb dell’IMP e che non hanno ricevuto un trattamento modificante la malattia fino a 4 anni o più dopo la loro ultima doseb dell’IMP) rispetto a quelle di altri partecipanti allo studio che hanno iniziato una terapia alternativa meno di 4 anni dopo la loro ultima doseb dell’IMP per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    3. Caratteristiche della RMc alla Visita dello studio 2 dei soggetti rispondenti a lungo termine (definiti come partecipanti allo studio che non hanno dimostrato alcuna evidenza di riattivazione della malattia sulla base della valutazione dello sperimentatore degli esiti clinici e della diagnostica per immagini fino a 4 anni o più dopo la loro ultima doseb dell’IMP e che non hanno ricevuto un trattamento modificante la malattia fino a 4 anni o più dopo la loro ultima doseb dell’IMP) rispetto a quelle di altri partecipanti allo studio che hanno iniziato una terapia alternativa meno di 4 anni dopo la loro ultima doseb dell’IMP per le popolazioni di CLARITY/CLARITY-EXT e ORACLE MS.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ad 1. Study Visit 1
    ad 2. Study Visit 1
    ad 3. Study visit 2; ad 1. Visita 1 dello studio
    ad 2. Visita 2 dello studio
    ad 3. Visita 3 dello studio
    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 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 studio
    Ambispective; data from patients participating to past trials. No IMP treatment during this study
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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 Information not present in EudraCT
    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
    Canada
    Georgia
    Korea, Republic of
    Lebanon
    Morocco
    Russian Federation
    Tunisia
    Ukraine
    United States
    Austria
    Belgium
    Bulgaria
    Croatia
    Estonia
    Finland
    France
    Germany
    Italy
    Latvia
    Lithuania
    Norway
    Poland
    Portugal
    Romania
    Spain
    Sweden
    Switzerland
    United Kingdom
    Czechia
    Greece
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 920
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 2021-09-01. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who cannot participate/complete the schedule due to cognitive impairment will be given the opportunity to participate by their proxy/caregiver/legal representative providing ICF on their behalf.
    Ai pazienti che non possono partecipare/completare il programma a causa di deterioramento cognitivo sarà data la possibilità di partecipare attraverso il proprio delegato/caregiver/rappresentante legale fornendo l'ICF ad agire per loro conto.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 1000
    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
    Non applicabile
    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 Decision2019-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-13
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