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    Summary
    EudraCT Number:2009-017978-21
    Sponsor's Protocol Code Number:EMR700568-012
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-11
    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 ConcernedCzechia - SUKL
    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 (PREMIERE)
    Prospektivní observační dlouhodobý bezpečnostní registr pacientů s
    roztroušenou sklerózou, kteří se účastnili klinické studie s cladribinem
    (PREMIERE)
    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
    Dlouhodobý bezpečnostní registr pacientů s roztroušenou sklerózou, kteří
    se zúčastnili klinickýcdh hodnocení s cladribinem
    A.3.2Name or abbreviated title of the trial where available
    PREMIERE Registry
    Registr PREMIERE
    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@merck.de
    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
    Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
    Pacienti s roztroušenou sklerózou, kteří se zúčastnili klinických
    hodnocení s cladribinem tablety
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Roztroušená skleróza
    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 15.1
    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 quantify and characterize the risk (cumulative incidence) of serious adverse drug reactions, including malignancies and serious infections
    • To assess time to resolution of lymphopenia among registry participants with persistent lymphopenia
    • To quantify and characterize the risk (cumulative incidence) of adverse events in the ‘Blood and Lymphatic System Disorders’ and ‘Neoplasms Benign, Malignant, and Unspecified’ System Organ Classes
    • Kvantifikovat a charakterizovat riziko (kumulativní výskyt) závažných
    nežádoucích účinků včetně malignit a těžkých infekcí
    • Vyhodnotit dobu do odeznění lymfopenie u účastníků registru s
    řetrvávající lymfopenií
    •Kvantifikovat a charakterizovat riziko (kumulativní výskyt) nežádoucích příhod v třídách orgánových systémů "Poruchy krve a lymfatického systému“ a „Novotvary benigní, maligní blíže neurčené“
    E.2.2Secondary objectives of the trial
    To assess pregnancy outcomes, including congenital malformations or other important health conditions in the offspring born to women exposed to oral cladribine
    Vyhodnotit výsledky těhotenství, včetně vrozených vad nebo jiných významných zdravotních následků u potomků žen léčených perorálním cladribinem
    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. This corresponds to five clinical trials (protocols number 25643, 26593, 27820, 27967 and 28821) and 2175 subjects.

    All subjects in the target population will be eligible for enrollment in the registry once their participation in the clinical trial has ended. The following inclusion criteria must be fulfilled:
    • Prior enrollment into selected clinical trials, 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 is given
    Cílovou skupinu v registru tvoří subjekty s roztroušenou sklerózou, které
    se zúčastnily klinických hodnocení I. až III. fáze s perorálním
    cladribinem organizovaných zadavatelem podle protokolu schváleného
    před předložením žádosti o registraci léčiva a které dokončily (poslední
    pacient, poslední návštěva) klinické hodnocení po listopadu 2008. Jedná
    se o pět klinických hodnocení (protokoly č. 25643, 26593, 27820, 27967
    a 28821) a o 2175 subjektů.

    Všechny subjekty v cílové skupině budou vhodné k zařazení do registru
    po skončení jejich účasti v klinickém hodnocení. Pro účast v registru
    musí být splněna tato kritéria pro zařazení:
    • Předchozí zařazení do vybraných klinických hodnocení bez ohledu na
    to, zda byly subjekty randomizovány k hodnocenému léčivu nebo
    placebu, a to po skončení účasti v klinickém hodnocen nebo v jeho
    prodloužené fázi
    • Podepsaný informovaný souhlas
    E.4Principal exclusion criteria
    The following reasons will exclude subjects from registry participation:

    • Subjects who cannot be reached by phone;
    • Subjects who are unable to answer the registry questionnaires and who do not have a next of kin or caregiver available to answer the registry questionnaires;
    • Subjects who – either during the lag interval or subsequently – enter an interventional study.
    Důvody pro nezařazení subjektů pro účast v registru:

    • Subjekty, které nelze zastihnout telefonicky
    • Subjekty, které nejsou schopné odpovědět na otázky v dotaznících
    registru a které nemají k dispozici příbuzného nebo poskytovatele
    péče/pečovatele, aby tyto dotazníky registru vyplnili
    • Subjekty, které buď během intervalu mezi koncem klinického
    hodnocení a zařazením do registru nebo následovně poté vstoupí do
    intervenčního klinického hodnocení.
    E.5 End points
    E.5.1Primary end point(s)
    • Cumulative incidence of serious adverse drug reactions (SADRs), including malignancies and serious infections
    • Time to resolution of lymphopenia, among registry participants with persistent lymphopenia
    • Cumulative incidence of all adverse events (AEs) in the “Blood and Lymphatic System Disorders” System Organ Class (SOC) and in the “Neoplasms Benign, Malignant, and Unspecified” SOC
    • Kumulativní výskyt závažných nežádoucích lékových reakcí (SADR), včetně malignit a vážných infekcí
    • Doba do ústupu lymfopenie u účastníků registru s perzistující
    lymfopénií
    • Kumulativní výskyt všech nežádoucích příhod v třídách orgánových systémů "Poruchy krve a lymfatického systému“ a „Novotvary benigní, maligní blíže neurčené“
    E.5.1.1Timepoint(s) of evaluation of this end point
    The cumulative incidence of SADRs and of AEs in the ‘Blood and Lymphatic System Disorders’ and ‘Neoplasms Benign, Malignant, and Unspecified’ SOCs will be summarized, and time to resolution of persistent lymphopenia will be estimated using the life table methodology.
    Sumarizován bude kumulativní výskyt SADR a nežádoucích příhod v třídách orgánových systémů "Poruchy krve a lymfatického systému“ a „Novotvary benigní, maligní blíže neurčené“ a analýza doby do ústupu perzistentní lymfopenie se odhadnou pomocí metodologie živých tabulek.
    E.5.2Secondary end point(s)
    Pregnancy outcomes, including congenital malformations, spontaneous abortion, elective abortion, stillbirth, ectopic pregnancy, molar pregnancy, and other important health conditions in the offspring
    Výsledky těhotenství včetně vrozených vad, spontání potraty, umělá
    přerušení těhotenství, mrtvě narozené děti, ektopické těhotenství,
    molární těhotenství a další významné nemoci u potomků
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportion of women and the frequency of the pregnancy outcomes including congenital disorders and important health conditions in the offspring, will be descriptively summarized.
    Podíl žen a frekvence výsledků těhotenství, včetně vrozených vad a dalších významných nemoci u potomků budou shrnuty deskriptivně.
    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
    Prospektivní observační bezpečnostní registr bez podávání hodnoceného
    léčiva
    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.8.5The trial involves multiple Member States No
    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 No
    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
    Poslední návštěva posledního subjektu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 2011-04-11. 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 state
    F.4.2 For a multinational trial
    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
    Není definováno v protokolu
    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 Decision2011-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-25
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