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    Summary
    EudraCT Number:2016-003552-75
    Sponsor's Protocol Code Number:CINC424A2411
    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:2016-12-09
    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 number2016-003552-75
    A.3Full title of the trial
    A multicenter phase II, open label, single arm study to evaluate the efficacy and safety of ruxolitinib in the treatment of anemic myelofibrosis patients
    Estudio fase II, multicéntrico, abierto, con un único brazo de tratamiento, para evaluar la eficacia y la seguridad de ruxolitinib en el tratamiento de pacientes anémicos con mielofibrosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    safety and efficacy of ruxolitinib in anemic myelofibrosis patients
    Ensayo de anemia en pacientes con mielofibrosis (MF).
    A.3.2Name or abbreviated title of the trial where available
    REALISE
    A.4.1Sponsor's protocol code numberCINC424A2411
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 Jakavi
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameruxolitinib
    D.3.2Product code INC424
    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 INNruxolitinib
    D.3.9.1CAS number 1092939-17-7
    D.3.9.2Current sponsor codeINC424
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    treatment of anemic myelofibrosis patients
    tratamiento de mielofibrosis en pacientes anémicos.
    E.1.1.1Medical condition in easily understood language
    myelofibrosis patients with anemia
    Pacientes anémicos con mielofibrosis
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10074692
    E.1.2Term Post essential thrombocythaemia myelofibrosis
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10074691
    E.1.2Term Post polycythaemia vera myelofibrosis
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the spleen length response rate at Week 24
    Determinar la tasa de respuesta de la longitud del bazo en la semana 24.
    E.2.2Secondary objectives of the trial
    - To determine the spleen length response rate at Week 48
    - To evaluate the effect of ruxolitinib on spleen length
    - To evaluate the effect of ruxolitinib on symptoms
    - To evaluate the effect of ruxolitinib on Patient Global Impression of Change (PGIC)
    - To evaluate the effect of ruxolitinib on transfusion requirements
    -Determinar la tasa de respuesta de la longitud del bazo en la semana 48.
    -Evaluar el efecto de ruxolitinib en la longitud del bazo.
    -Evaluar el efecto de ruxolitinib en los síntomas.
    -Evaluar el efecto de ruxolitinib en la impresión global del paciente sobre los cambios (PGIC)
    -Evaluar el efecto de ruxolitinib en la necesidad de transfusión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients aged ≥ 18 years of age.
    - Patients must be diagnosed with PMF, according to the 2016 revised International Standard Criteria (Arber et al, 2016), PPV MF or PET-MF (Barosi 2008), irrespective of JAK2 mutation status.
    - Patients with palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
    - Patients with a hemoglobin less than 10 g/dL
    - Patients with a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
    - Patients with a peripheral blood blast percentage count of < 10%.

    Additional inclusion criteria as per full protocol may apply.
    -Pacientes hombres o mujeres con edad ≥ 18 años.
    -Pacientes con diagnóstico de PMF, según los criterios estándares internacionales revisados 2016 (Arber et al, 2016), PPV-MF o PET-MF (Barosi 2008), independientemente del estado mutacional de JAK2.
    -Pacientes con esplenomegalia palpable que sea igual o mayor en más de 5 cm por debajo del margen costal izquierdo
    -Pacientes con un nivel de hemoglobina inferior a 10 g/dL
    -Los pacientes con historial previo de transfusiones deberán presentar un registro de transfusión documentado en las 12 semanas previas a la visita basal.
    -Pacientes con un recuento de porcentaje de blastos en sangre periférica de < 10%.
    Pueden aplicarse criterios de inclusión adicionales según el protocolo completo.
    E.4Principal exclusion criteria
    - Patients with prior treatment with any JAK1 or JAK2 inhibitor.
    - Patients with inadequate bone marrow reserve at baseline visit asdemonstrated by at least one of the following:
     ANC that is ≤ 1,000/μL.
     Platelet count that is <50,000/μL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
     Hemoglobin count that is ≤ 6.5 g/dL despite transfusions.
    - Patients with severely impaired renal function
    - Patients with inadequate liver function
    - Patients being treated concurrently with a strong (potent) systemic inhibitor or inducer of CYP3A4 at the time of Screening
    - Acute viral hepatitis or active chronic hepatitis B or C infection.
    - History of progressive multifocal leuko-encephalopathy (PML)

    Additional exclusion criteria as per full protocol may apply.
    -Pacientes con tratamiento previo con cualquier inhibidor de JAK1 o de JAK2.
    -Pacientes con reserva de médula ósea insuficiente en la visita basal, demostrado con al menos uno de los siguientes:
    .RAN que sea ≤ 1000/µL.
    .Recuento de plaquetas que sea < 50.000/µL sin la asistencia de factores de crecimiento, factores trombopoyéticos o transfusiones de plaquetas
    .Recuento de hemoglobina que sea ≤ 6.5 g/dL a pesar del uso de transfusiones.
    -Pacientes con deterioro grave de la función renal
    -Pacientes con función hepática inadecuada
    -Pacientes que sean tratados concomitantemente con un inhibidor o inductor sistémico potente de CYP3A4 en el momento de la selección.
    -Hepatitis viral aguda o infección por hepatitis B o C crónica activa.
    -Historial previo de leucoencefalopatía multifocal progresiva (PML)

    Pueden aplicarse criterios de exclusión adicionales según el protocolo completo.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving a 50% reduction in spleen length at Week 24
    Proporción de pacientes que alcanzan el 50% de la reducción de la longitud del bazo en la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    - Proportion of patients achieving a 50% reduction in spleen length at week 48
    - Percent change from baseline in spleen length over time
    - Summary of the Modified MFSAF v2.0 and MF-7 over time
    - PGIC at each visit where measured
    - Summary of transfusions over time
    -Proporción de pacientes que alcanzan el 50% de la reducción de la longitud del bazo en la semana 24
    - Porcentage de cambios desde la visita basal en la longitud del bazo en el tiempo.
    - Listado de Modificaciones MFSAF v2.0 and MF-7 en el tiempo.
    - PGIC en cada visita donde se ha medido.
    - Listado de transfusiones recibidas en el tiempo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Week 48
    - Week 48
    - Week 48
    - Week 48
    - Week 48
    - Semana 48
    - Semana 48
    - Semana 48
    - Semana 48
    - Semana 48
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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.8.2.4Number 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Chile
    Germany
    Greece
    Hungary
    Italy
    Japan
    Russian Federation
    Spain
    Turkey
    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
    The end of the study (last patient last visit) will occur after completion of the last follow up visit of the last patient on treatment with ruxolitinib.
    El final del studio (ultimo paciente/ última visita) ocurrirá tras completar la última visita de seguimiento del ultimo paciente en tratamiento con ruxolitinib.
    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 months9
    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 months11
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 No
    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 34
    F.4.2.2In the whole clinical trial 50
    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)
    Patients completing this trial may continue to be treated for their myelofibrosis with ruxolitinib or any other conventional therapy as judged by the physician and agreed by the patient. Should ruxolitinib be the therapy of choice, patients can continue treatment with commercial ruxolitinib according to local regulations. If ruxolitinib is not commercially available to patients after completing the study, Novartis will have a transition plan in place to ensure have access to ruxolitinib.
    Los pacientes que completen este ensayo pueden continuar con el tto. con Ruxolitinib o con cualquier otra terapia convencional para su MF, según el criterio médico y de acuerdo con el paciente. Si el ruxolitinib es la terapia de elección, los pacientes pueden continuar con el tto. de ruxolitinib comercial de acuerdo con las regulaciones locales. Si el ruxolitinib comercial no está disponible para los pacientes , Novartis tendrá un plan de transición en su lugar para asegurar su abastecimiento
    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 Decision2017-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-27
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