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    Summary
    EudraCT Number:2009-017978-21
    Sponsor's Protocol Code Number:EMR700568-012
    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:2011-11-17
    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 number2009-017978-21
    A.3Full title of the trial
    Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials
    Registro de seguridad prospectivo y observacional a largo plazo de pacientes con esclerosis múltiple que han participado en ensayos clínicos con cladribina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials
    Registro de seguridad a largo plazo de pacientes con esclerosis múltiple que han participado en ensayos clínicos con cladribina.
    A.3.2Name or abbreviated title of the trial where available
    PREMIERE Registry
    A.4.1Sponsor's protocol code numberEMR700568-012
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01013350
    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 Serono S.A. - Geneva
    B.1.3.4CountrySwitzerland
    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 Serono S.A. - Geneva
    B.4.2CountrySwitzerland
    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+ 49 6151 72 5200
    B.5.5Fax number+ 49 6151 72 2000
    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 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 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.3.9.2Current sponsor codeEMD280922
    D.3.9.3Other descriptive name2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine
    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
    Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina.
    E.1.1.1Medical condition in easily understood language
    Esclerosis Múltiple
    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 14.0
    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
    El objetivo principal del registro consiste en generar datos de seguridad a largo plazo sobre la cladribina oral en esclerosis múltiple (EM) mediante el cálculo de los factores de riesgo y frecuencia para sucesos de estudio definidos a lo largo de un periodo prolongado que se extiende más allá de la exposición a la cladribina, en una población de sujetos a los que se haya expuesto a cladribina oral en ensayos clínicos seleccionados por el promotor y sus respectivas ampliaciones.
    E.2.2Secondary objectives of the trial
    *Incidencia acumulada de síndromes mielodisplásicos (SMD) y toxicidad hematológica.
    *Análisis descriptivos de características demográficas y de EM de los sujetos que experimenten y los que no experimenten sucesos de estudio.
    *Cocientes de riesgos instantáneos de infecciones graves y seleccionadas, enfermedades malignas y muertes en sujetos expuestos a la cladribina en comparación con los sujetos no expuestos a la cladribina o los grupos de baja exposición acumulada.
    *Tasa de recurrencia de sucesos de estudio en sujetos que han sufrido un suceso incidental, en relación con el tiempo-persona total de seguimiento.
    *Frecuencia de acontecimientos clínicamente relevantes distintos
    de infecciones seleccionadas y graves, enfermedades malignas, muertes, SMD y toxicidad hematológica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The registry target population includes all subjects who participated in Sponsor oral cladribine phase I to III clinical trials in MS associated with a protocol approved prior to the time of submission of the marketing application and completed (last patient, last visit) after November 2008.

    All subjects in the target population will be eligible for enrollment in the registry once their participation in the clinical trial has ended. Both the following inclusion criteria must be fulfilled:
    ? Prior enrollment into selected clinical trials of the cladribine development program as described in section 5.1 regardless of randomization to either IMP or placebo, once participation in the clinical trial or in the clinical trial extension has ended
    ? Written informed consent was given
    Todos los sujetos incluidos en un ensayo clínico seleccionado del programa de desarrollo de cladribina oral serán aptos para su inclusión en el registro una vez que haya concluido su participación en el ensayo clínico. Deben cumplirse los dos criterios de inclusión siguientes: *Inclusión previa en ensayos clínicos seleccionados del programa de desarrollo de cladribina oral, independientemente de su pertenencia aleatoria al grupo del producto de fase de investigación clínica (PEI) o al grupo placebo, una vez que haya concluido su participación en el ensayo clínico o en la ampliación del ensayo clínico.
    *Concesión del consentimiento informado por escrito.
    E.4Principal exclusion criteria
    The following two reasons will exclude subjects from registry participation:

    ? Subjects who cannot be reached by phone, or;
    ? Subjects unable to answer the registry questionnaires and who do not have a next of kin or caregiver able to answer the registry questionnaires
    *Sujetos con los que no pueda establecerse comunicación telefónica. *Sujetos que no puedan responder a los cuestionarios del registro y que no tengan un familiar próximo o cuidador disponible para
    responder a los cuestionarios del registro.
    E.5 End points
    E.5.1Primary end point(s)
    ? Cumulative incidence of severe and selected infections, malignancies, and deaths
    ? Assessment of cumulative incidence patterns over time since first exposure to cladribine/placebo;
    ? Time to resolution of lymphopenia, among registry participants with persistent lymphopenia;
    ? Frequency of pregnancies and pregnancy outcomes (spontaneous abortion, elected abortion, stillbirth, and live birth?full term, premature, overdue, and presence of congenital anomalies) occurring among female subjects exposed to cladribine, as well as among female partners of male subjects in the program, and developmental disabilities, structural malformations, or other important health conditions in the offspring. Time between seeking pregnancy and becoming pregnant among participants (or partners) seeking pregnancy.
    *Incidencia acumulada de infecciones graves y seleccionadas, enfermedades malignas y muertes.
    *Valoración de patrones de incidencia acumulada en el tiempo tras la primera exposición a cladribina oral/placebo. *Tiempo de resolución de linfopenia, entre participantes en el registro con linfopenia persistente. *Frecuencia de embarazos y desenlaces del embarazo (aborto espontáneo, aborto voluntario, muerte fetal y nacimiento de feto vivo [nacido a término, prematuro, retrasado y presencia de anomalías congénitas]) entre sujetos femeninos expuestos a la cladribina, así como entre parejas de sujetos masculinos del programa, y discapacidades del desarrollo, malformaciones estructurales u otros problemas médicos importantes en los hijos. Tiempo entre la búsqueda de embarazo y el embarazo efectivo entre las participantes (o las parejas de los participantes varones) que buscan quedar embarazadas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Preliminary analyses of the primary and secondary endpoints will be conducted when 2 years of follow-up data are available for 1000 subjects after registry enrollment. Thereafter these analyses will be conducted every 2 years.
    Los análisis preliminares de los objetivos primarios y secundarios se llevará a cabo en 2 años de seguimiento se dispone de datos de 1000 sujetos después de la inscripción del registro. A partir de entonces estos análisis se llevará a cabo cada 2 años.
    E.5.2Secondary end point(s)
    ? Cumulative incidence of MDS, and hematological toxicity;
    ? Descriptive analyses of demographic and MS disease characteristics of subjects who experience and those who do not experience study events;
    ? Hazard ratios for severe and selected infections, malignancies, and deaths in cladribine exposed subjects compared with cladribine unexposed subjects or low cumulative cladribine exposure groups;
    ? Rate of recurrence of study events in subjects who have had an incident events, accounting for the total person-time of follow-up;
    ? Frequency of clinically relevant events other than selected and severe infections, malignancies, deaths, MDS, and hematological toxicity.
    Incidencia acumulada de síndromes mielodisplásicos (SMD) y toxicidad hematológica.
    · Análisis descriptivos de características demográficas y de EM de los sujetos que experimenten y los que no experimenten sucesos
    de estudio.
    · Cocientes de riesgos instantáneos de infecciones graves y seleccionadas, enfermedades malignas y muertes en sujetos expuestos a la cladribina encomparación con los sujetos no expuesto a la cladribina o los grupos de baja exposición acumulada.
    · Tasa de recurrencia de sucesos de estudio en sujetos que han sufrido un suceso incidental, en relación con el tiempo-persona total de seguimiento.
    · Frecuencia de acontecimientos clínicamente relevantes distintos de infecciones seleccionadas y graves, enfermedades malignas, muertes, SMD y toxicidad hematológica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Preliminary analyses of the primary and secondary endpoints will be conducted when 2 years of follow-up data are available for 1000 subjects after registry enrollment. Thereafter these analyses will be conducted every 2 years.
    Los análisis preliminares de los objetivos primarios y secundarios se llevará a cabo en 2 años de seguimiento se dispone de datos de 1000 sujetos después de la inscripción del registro. A partir de entonces estos análisis se llevará a cabo cada 2 años.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Prospective observational safety registry with no IMP administration
    Registro prospectivo observacional de seguridad sin administración de IMP.
    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) Yes
    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 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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA130
    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
    Argentina
    Australia
    Austria
    Belgium
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Denmark
    Estonia
    Finland
    France
    Georgia
    Germany
    Greece
    India
    Italy
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Macedonia, the former Yugoslav Republic of
    Morocco
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Saudi Arabia
    Serbia
    Singapore
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Tunisia
    Turkey
    Ukraine
    United Arab Emirates
    United Kingdom
    United States
    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
    The duration of follow-up for all subjects will extend to the end of the registry - which is planned for 2018 - or 8 years after enrollment into the first cladribine clinical trial (first visit), whichever occurs first.
    La duración del seguimiento para todos los sujetos abarcará hasta el final del registro, que está previsto para 2018 u ocho años después de la inclusión del sujeto en el primer ensayo clínico de cladribina
    (primera visita), lo que ocurra antes.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years8
    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.1.1Number of subjects for this age range: 0
    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: 2159
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 2011-11-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state37
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 976
    F.4.2.2In the whole clinical trial 2175
    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 defined in the protocol
    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 Decision2011-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
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