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    Summary
    EudraCT Number:2019-000069-19
    Sponsor's Protocol Code Number:MS700568_0026
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 ConcernedSpain - AEMPS
    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
    Evaluación de los resultados a largo plazo y de la durabilidad del efecto después del tratamiento con los comprimidos de cladribina para la esclerosis múltiple: un estudio ambispectivo, exploratorio, en fase IV de pacientes que han participado anteriormente en los ensayos clínicos CLARITY/CLARITY-EXT y 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
    Evaluación de los resultados a largo plazo y de la durabilidad del efecto después del tratamiento con los comprimidos de cladribina para la esclerosis múltiple: un estudio ambispectivo, exploratorio, en fase IV de pacientes que han participado anteriormente en los ensayos clínicos CLARITY/CLARITY-EXT y ORACLE MS
    A.3.2Name or abbreviated title of the trial where available
    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 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 Europe B.V.
    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 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 INNCLADRIBINE
    D.3.9.1CAS number 4291-63-8
    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
    Multiple Sclerosis
    ESCLEROSIS MULTIPLE
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    ESCLEROSIS MULTIPLE
    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.
    Evaluar la movilidad a largo plazo después del tratamiento con un PEI (comprimidos de cladribina o placebo) como parte de los ensayos clínicos CLARITY/CLARITY-EXT y ORACLE MS en fase III.
    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. Evaluar el estado de discapacidad a largo plazo después del tratamiento con IMP como parte de los ensayos clínicos de Fase III ORACLE MS y CLARITY / CLARITY-EXT para las poblaciones de CLARITY / CLARITY-EXT y ORACLE MS.
    2. Evaluar las diferencias en las características clínicas entre los responders a largo plazo y los participantes del estudio
    que requieren terapias alternativas después del tratamiento con IMP para las poblaciones CLARITY / CLARITY-EXT y ORACLE MS.
    Subestudio de MRI:
    3. Para evaluar las diferencias en las características de la resonancia magnética (RMN) entre los responders a largo plazo y los participantes del estudio que requieren terapias alternativas después del tratamiento con IMP para el
    CLARITY / CLARITY-EXT y ORACLE MS poblaciones.
    E.2.3Trial contains a sub-study No
    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.
    Para estudio principal y sub estudio de resonancia magnética:
    1. Pacientes con EM aleatorizados en ensayos clínicos CLARITY / CLARITY-EXT que han recibido ≥ 1 ciclo de IMP (tabletas de Cladribine o placebo).
    o
    Pacientes con su FCDE aleatorizado en el ensayo clínico ORACLE MS que han recibido
    ≥ 1 ciclo de IMP (Cladribine Tablets o placebo).
    2. Los pacientes pueden dar su consentimiento informado firmado, que incluye el cumplimiento de los requisitos y restricciones enumerados en la ICF y este protocolo.
    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).
    Estudio principal
    Cualquier condición, incluyendo cualquier estado de enfermedad no controlada que no sea la EM, que en el
    opinión, constituye un riesgo inapropiado o una contraindicación para la participación en el estudio o que
    Podría interferir con los objetivos, la conducta o la evaluación del estudio.
    MRI-Subestudio:
    a. Participantes del estudio que están embarazadas.
    b. El paciente está tomando Cladribine Tablets como parte de otro estudio en el momento del inicio de
    este estudio (es decir, pacientes que participan en un ensayo clínico o estudio observacional pero no
    recibir tabletas de Cladribine como parte de estos estudios se les permite participar en el subestudio).
    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.
    Proporción de participantes en el estudio que usan una silla de ruedas (definida como incapaz de caminar más de aproximadamente 5 metros, incluso con ayuda, esencialmente restringida a una silla de ruedas; ruedas en silla de ruedas estándar y
    transferencias solo en silla de ruedas unas 12 horas al día) la mayor parte del tiempo en los 3 meses anteriores a la Visita de estudio 1 para las poblaciones de CLARITY / CLARITY-EXT y ORACLE MS, determinada a través de:
    • Escala ampliada del estado de discapacidad (EDSS)
    puntuación de 7.0 o superior (si está disponible), o
    • Datos de descripción clínica alternativa en registros médicos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study visit 1
    Visita de estudio 1
    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. Proporción de participantes en el estudio con EDSS sostenido de 3 meses de 6.0 o más en el último año antes de la inscripción (discapacidad de la educación consistente con EDSS en al menos 2 visitas clínicas con una diferencia de no menos de 3 meses) según lo determine la documentación de EDSS o la correspondiente Descripción clínica en registros médicos para las poblaciones de CLARITY / CLARITY-EXT y ORACLE MS
    2. Características clínicas de los respondedores a largo plazo (definidos como participantes del estudio que no demostraron evidencia de reactivación de la enfermedad según la evaluación del investigador de los resultados clínicos y de imagen hasta el Año 4 o posterior a su última dosis de PIM y que no recibieron modificación de la enfermedad tratamiento hasta el Año 4 o posterior a su última dosis de IMP) en comparación con los de otros participantes del estudio que comenzaron una terapia alternativa menos de 4 años después de su última dosis de IMP para las poblaciones de CLARITY / CLARITY-EXT y ORACLE MS.
    Subestudio de MRI:
    3. Características de la RM en la visita de estudio 2 de pacientes que respondieron a largo plazo (definidos como participantes del estudio que no demostraron evidencia de reactivación de la enfermedad según la evaluación del investigador de datos clínicos y
    resultados de imagen hasta el año 4 o posterior a su última dosis de IMP y que no recibieron tratamiento modificador de la enfermedad hasta el año 4 o posterior a su última dosis de IMP) en comparación con los de otros participantes del estudio que comenzaron una terapia alternativa menos de 4 años después su última dosis de IMP para las poblaciones de CLARITY / CLARITY-EXT y 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
    1. Visita de estudio 1
    2. Visita de estudio 2
    3. Visita de estudio 3
    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
    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.8.3 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 concerned2
    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 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
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Estonia
    Finland
    France
    Georgia
    Germany
    Greece
    Italy
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Morocco
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Spain
    Sweden
    Switzerland
    Tunisia
    Ukraine
    United Kingdom
    United States
    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
    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 months6
    E.8.9.1In the Member State concerned days29
    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 2019-07-04. 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 or complete the schedule of activities due to cognitive impairment or relapsing episode will be given the opportunity to participate by their proxy/caregiver/legal representative providing consent on their behalf.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    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
    No aplicable
    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 Decision2019-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-05-13
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