Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43800   clinical trials with a EudraCT protocol, of which   7272   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-000063-79
    Sponsor's Protocol Code Number:MN42989
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-23
    Trial 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 number2021-000063-79
    A.3Full title of the trial
    A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY
    ESTUDIO DE FASE IV, MULTICÉNTRICO Y ABIERTO PARA EVALUAR LA CONCENTRACIÓN DE LINFOCITOS B EN LACTANTES DE MUJERES EN PERÍODO DE LACTANCIA AFECTADAS DE SCA O EM QUE RECIBEN OCRELIZUMAB (ESTUDIO SOPRANINO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab
    Estudio para Evaluar La Concentración De Linfocitos B en Lactantes de Mujeres en Período De Lactancia Afectadas de síndrome clínico aislado o esclerosis múltiple
    A.4.1Sponsor's protocol code numberMN42989
    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 SponsorF. Hoffmann-La Roche Ltd
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34913257300
    B.5.5Fax number+34913248196
    B.5.6E-mailspain.start_up_unit@roche.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 Ocrevus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOcrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913
    D.3.9.3Other descriptive nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized monoclonal antibody
    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 (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Esclerosis múltiple (EM) o síndrome clínico aislado (SCA) en consonancia con las indicaciones autorizadas en el país
    E.1.1.1Medical condition in easily understood language
    MS is a chronic disease in which the immune system attacks the insulation and support around the nerve cells in the brain, spinal cord and optic nerves, causing inflammation and consequent damage.
    EM: enf crónica en q el sistema inmunológico ataca el aislamiento y el soporte alrededor de células nerviosas del cerebro, médula espinal y nervios ópticos, provocando inflamación y consiguiente daño
    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 PT
    E.1.2Classification code 10071068
    E.1.2Term Clinically isolated syndrome
    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 whether infants of lactating women with CIS or MS receiving ocrelizumab post-partum present with B cell depletion
    • To evaluate the exposure to ocrelizumab in infants of lactating women with CIS or MS receiving ocrelizumab post-partum
    -Evaluar si los lactantes de mujeres afectadas de SCA o EM que reciben ocrelizumab en el puerperio presentan destrucción de linfocitos B
    -Evaluar la exposición a ocrelizumab en lactantes de mujeres afectadas de SCA o EM que reciben ocrelizumab en el puerperio
    E.2.2Secondary objectives of the trial
    • To evaluate B cell levels in infants of lactating women with CIS or MS receiving ocrelizumab post-partum
    • To evaluate transfer of ocrelizumab into breastmilk of lactating women with CIS or MS receiving ocrelizumab post-partum
    • To evaluate the maximum exposure to ocrelizumab in infants of lactating women with CIS or MS receiving ocrelizumab post-partum
    • To evaluate whether there is transfer of ocrelizumab from the mother to the infant via breastmilk
    • To evaluate whether infants of lactating women with CIS or MS receiving ocrelizumab post-partum are able to mount humoral immune responses to clinically relevant vaccines
    • To evaluate the safety of ocrelizumab in lactating women with CIS or MS receiving ocrelizumab post-partum and in their respective infants
    -Evaluar los niveles de linfocitos B en lactantes de mujeres afectadas de SCA o EM que reciben ocrelizumab en el puerperio
    - Evaluar el paso de ocrelizumab a la leche materna de mujeres lactantes con SCA o EM que reciben ocrelizumab en el puerperio
    - Evaluar la exposición máxima a ocrelizumab en lactantes de mujeres afectadas de SCA o EM que reciben ocrelizumab en el puerperio
    - Evaluar si hay transferencia de ocrelizumab de la madre al lactante a través de la leche materna
    - Evaluar si los lactantes de mujeres con SCA o EM que reciben ocrelizumab en el puerperio son capaces de generar respuestas inmunitarias humorales a vacunas de relevancia desde el punto de vista clínico
    - Evaluar la seguridad de ocrelizumab en mujeres en período de lactancia afectadas de SCA o EM que reciben ocrelizumab en el puerperio, y en sus respectivos lactantes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • An Informed Consent Form for participation of the maternal subject and her infant (for collection of blood, infant demographic and AE data) is signed and dated by the subject. Where applicable, the written Informed Consent form with respect to the infant is also signed and dated by the holder of parental rights as designated by the maternal subject
    • Woman is able and willing to comply with the study protocol, according to the judgment of the Investigator, in particular: 1] Woman is willing to breastfeed (either exclusively, or with formula supplementation) for at least 60 days after the first post-partum ocrelizumab infusion (this decision is to be taken prior to and independent from study participation) 2] Woman is willing to provide breastmilk samples before and after their first and, if applicable, second post-partum ocrelizumab infusion
    • Woman is between 18 and 40 years of age at screening
    • Woman has a diagnosis of MS or CIS (in line with the locally approved indications)
    • Woman has delivered a term singleton infant (>=37 weeks gestation)
    • Infant is between 2-24 weeks of life
    • For women who received commercial ocrelizumab (OCREVUS) before enrolment: documentation that last exposure ocrelizumab occurred more than 3 months before the last menstrual period (LMP) (i.e. excluded a potential fetal exposure) and was given at the approved dose of 2x300 mg or 1x600 mg
    • Woman agrees to use acceptable contraceptive methods during the study
    • La participante firma y fecha un formulario de consentimiento informado (FCI) para la participación de la madre y su hijo (relativo a la recogida de sangre, datos personales del bebé y datos de AA). Cuando proceda, el FCI escrito referente al bebé también va firmado y fechado por el titular de los derechos parentales que haya designado la madre participante.
    • La mujer tiene la capacidad y la voluntad de cumplir el protocolo del estudio, a juicio del investigador, y, en particular: 1) La mujer está dispuesta a dar el pecho (de manera exclusiva o complementándolo con leche maternizada) durante al menos 60 días después de la primera infusión de ocrelizumab en el puerperio (esta decisión debe tomarse antes de la participación en el estudio y con independencia de esta). 2) La mujer está dispuesta a aportar muestras de leche materna antes y después de la primera infusión de ocrelizumab del puerperio y, si procede, de la segunda.
    • La mujer tiene entre 18 y 40 años de edad en la selección.
    • La mujer tiene diagnóstico de EM o SCA (en consonancia con las indicaciones autorizadas en el país).
    • La mujer ha dado a luz a término un único bebé (≥37 semanas de gestación).
    • El lactante tiene entre 2 y 24 semanas de vida.
    • En el caso de las mujeres que recibieron ocrelizumab de forma comercial (OCREVUS) antes de la inclusión: documentación de que la última exposición a este fármaco se produjo más de 3 meses antes del UPM (es decir, ha quedado descartada una posible exposición fetal) y se administró a la dosis autorizada de 2 × 300 mg o 1 × 600 mg.
    • La mujer accede a utilizar métodos anticonceptivos aceptables durante el estudio.
    E.4Principal exclusion criteria
    Exclusions related to the mother
    • Woman received last dose of ocrelizumab <3 months before the LMP or during pregnancy (i.e. there was a potential fetal exposure to ocrelizumab)
    • Active infections (note: the woman may be included once the infection is treated and is resolved; women with bilateral mastitis infection should not have samples collected until the infection is completely resolved)
    • Prior or current history of primary or secondary immunodeficiency, or woman in an otherwise severely immunocompromised state. Woman may be re-screened and included if condition resolves
    • Woman with known active malignancies or being actively monitored for recurrence of malignancy including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin). Women with high risk of breast malignancies undergoing prophylactic treatment with drugs such as tamoxifen are excluded
    • Woman has history of breast implants, breast augmentation, breast reduction surgery or mastectomy
    • Woman has prior or current history of chronic alcohol abuse or drug abuse
    • Woman has any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, would compromise the woman's ability to participate in this study
    • Treatment with a disease-modifying therapy (DMT) for CIS or MS during pregnancy and/or first weeks post-partum, with the exception of formulations of interferon-beta, glatiramer acetate or pulsed corticosteroids
    • Drugs known to transfer to the breastmilk and with established or potential deleterious effects for the infant, including but not limited to aspirin (risk of Reye’s syndrome), tetracyclines or fluoroquinolones
    • Treatment with any investigational agent within 6 months or five half-lives of the investigational drug (whichever is longer) prior to the LMP, unless the investigational agent is ocrelizumab administered >3 months prior to the LMP in the context of a study or registry sponsored by Roche

    Exclusions related to the infant
    • Infant is >24 weeks of life at the time of the mother’s first dose of ocrelizumab
    • Infant has any abnormality that may interfere with breastfeeding or milk absorption, including but not limited to cleft palate and/or lip, congenital diaphragmatic hernia and esophageal atresia
    • Infant has an active infection. Infant may be included once the infection resolves
    • Infant has at least one documented brief resolved unexplained event (BRUE), as defined by the 2016 Guidelines of the American Academy of Pediatrics

    Exclusions Related to Laboratory Findings
    • Mother with any abnormal screening laboratory value that is clinically relevant should be retested only once in order to rule out any progressive or uncontrolled underlying condition. The last value before study entry must meet study criteria
    • Mother with positive screening tests for hepatitis B, determined by a positive hepatitis B surface antigen (HBsAg) result (current infection) or positive hepatitis B core antibody (HBcAb) titers (previous infection) will be excluded. Women with documented history of hepatitis B virus (HBV) vaccination or positive hepatitis B surface antibody (HBsAb) titers are eligible
    Exclusiones relativas a la madre
    ●La mujer recibió la última dosis de ocrelizumab menos de 3 meses antes del UPM o durante el embarazo (es decir, hubo una posible exposición fetal al fármaco).
    ●Infecciones activas (nota: se puede incluir a la mujer una vez que la infección se ha tratado y se ha resuelto; no se deben recoger muestras de aquellas mujeres que presenten infección bilateral por mastitis hasta que esta se resuelva por completo).
    ● Antecedentes o diagnóstico actual de inmunodeficiencia primaria o secundaria, o mujer que, por lo demás, se encuentre en un estado gravemente inmunodeprimido. La mujer puede volver a someterse a selección e incluirse si la afección se resuelve.
    ● Mujer con neoplasias malignas activas conocidas, o bajo supervisión activa destinada a detectar la recurrencia de neoplasia maligna, incluidos tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y carcinoma espinocelular in situ de la piel). Se excluye a las mujeres que presenten alto riesgo de padecer neoplasias malignas de mama y sometidas a tratamiento profiláctico con fármacos como el tamoxifeno.
    ● La mujer tiene antecedentes de implantes mamarios, aumento de pecho, operaciones de reducción de pecho o mastectomía.
    ● La mujer tiene antecedentes o diagnóstico actual de alcoholismo crónico o drogadicción.
    ● La mujer tiene una afección médica, obstétrica o psiquiátrica que, en opinión del investigador, comprometería su capacidad para participar en este estudio.
    ● Tratamiento con un TME para el SCA o la EM durante el embarazo o las primeras semanas del puerperio, a excepción de formulaciones de interferón β, acetato de glatirámero o corticoesteroides en pulsos.
    ● Toma de fármacos que se sabe que se transfieren a la leche materna y que tienen efectos nocivos constatados o potenciales para el bebé, incluidos, entre otros, ácido acetilsalicílico (riesgo de síndrome de Reye), tetraciclinas o fluoroquinolonas. En el Apéndice 2 puede consultarse una lista más pormenorizada, aunque no exhaustiva.
    ● Tratamiento con cualquier fármaco en investigación dentro de los 6 meses o cinco semividas del producto en investigación (el período que sea más largo) anteriores al UPM, a menos que el fármaco en investigación sea ocrelizumab administrado más de 3 meses antes del UPM en el contexto de un estudio o registro promovido por Roche.
    Exclusiones relativas al lactante
    El lactante tiene más de 24 semanas de vida en el momento de la primera dosis de ocrelizumab de la madre.
    ● El lactante presenta alguna anomalía que puede interferir en la lactancia o la absorción de leche, incluidas, entre otras, fisura palatina o labio leporino, hernia diafragmática congénita y atresia esofágica.
    ● El lactante tiene una infección activa. Una vez que esta se resuelva, se puede incluir al lactante.
    ● El lactante presenta cualquier otra afección médica o anomalía que, en opinión del investigador, pudiera poner en peligro su capacidad para participar en este estudio; incluida la interferencia en la interpretación de los resultados de la investigación.
    ● El lactante presenta al menos un acontecimiento breve, resuelto e inexplicado (brief resolved unexplained event, BRUE) documentado, tal y como se definen en las directrices de 2016 de la Academia Estadounidense de Pediatría.

    Exclusiones relativas a los hallazgos analíticos
    ● Aquella madre que presente en la selección algún valor analítico anómalo clínicamente relevante debe volver a analizarse solo una vez, para descartar cualquier enfermedad preexistente progresiva o no controlada. El último valor anterior a la entrada el estudio debe cumplir los criterios del estudio.
    ● Se excluirá a la madre que tenga prueba positiva de detección de la hepatitis B, determinada por un resultado positivo en el antígeno de superficie (HBsAg; infección actual) o títulos positivos de anticuerpos centrales (HBcAb; infección anterior). Son aptas las mujeres que presenten antecedentes documentados de vacunación contra el virus de la hepatitis B (VHB) o títulos positivos de anticuerpos de superficie de la hepatitis B (HBsAb).
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of infants with B cell levels (CD19+ cells, absolute counts in blood) below the lower limit of normal (LLN), measured 30 (±2) days after the mother’s first ocrelizumab post-partum infusion
    2. Estimated average oral daily infant dosage (ADID), calculated as the ocrelizumab average milk concentration over 60 days multiplied by an estimated infant milk intake of 150 mL/kg/day
    1. Proporción de lactantes que presenten una concentración de linfocitos B (células CD19+, cifra absoluta en sangre) situada por debajo del límite inferior de la normalidad (LIN), determinada 30 (±2) días después de la primera infusión de ocrelizumab que reciba la madre en el puerperio
    2. Dosis diaria media estimada del lactante (DDMeL) por vía oral, calculada como concentración media de ocrelizumab en la leche a lo largo 60 días multiplicada por una ingesta de leche estimada en 150 ml/kg/día
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At 30 days after the mother’s first ocrelizumab post-partum infusion
    2. Over 60 days after the mother’s first ocrelizumab post-partum infusion
    1. A los 30 días después de la primera infusión de Ocrelizumab post-parto de la madre
    2. Más de 60 días después de la primera infusión postparto de ocrelizumab de la madre
    E.5.2Secondary end point(s)
    1. B cell levels (CD19+ cells, absolute counts and percentage of lymphocytes) measured 30 (±2) days after the mother’s first ocrelizumab post-partum infusion
    2. Area under the milk concentration-time curve (AUC) of ocrelizumab in mature breastmilk (i.e. milk produced after day 14 post-partum) over 60 days after the first post-partum ocrelizumab infusion
    3. Average and peak ocrelizumab milk concentration as well as time to reach peak milk concentration, measured over 60 days after the mother’s first postpartum ocrelizumab infusion
    4. Estimated maximum oral daily infant dosage (MDID) calculated as the peak ocrelizumab milk concentration multiplied by an estimated infant milk intake of 150 mL/kg/day measured over 60 days after the mother’s first post-partum ocrelizumab infusion
    5. Serum concentration of ocrelizumab in the infant measured 30 (±2) days after the mother’s first ocrelizumab post-partum infusion
    6. Mean titers of antibody immune response(s) to vaccination against common childhood immunizations with full or partial doses given prior to 1 year, measured 1 month after the first dose of MMR vaccine or at month 13 (±14 days) in case MMR vaccine is not planned to be administered
    7. Proportion of infants with positive humoral response (seroprotective titers; as defined for the individual vaccine) to vaccines measured 1 month after the first dose of MMR vaccine, or at month 13 (± 14 days) in case MMR vaccine is not planned to be administered
    8. Rate and nature of adverse events (AEs) in the mother throughout the study, including changes in clinical and laboratory results
    9. Rate and nature of AEs in the infant throughout the study, including infections and hospitalizations
    1. Concentración de linfocitos B (células CD19+, cifras absolutas y porcentaje de linfocitos) determinada 30 (±2) días después de la primera infusión de ocrelizumab que reciba la madre en el puerperio
    2. Área bajo la curva (ABC) de concentración-tiempo de ocrelizumab en la leche materna madura (es decir, leche producida después del día 14 tras el parto) a lo largo de los 60 días siguientes a la primera infusión posparto de ocrelizumab
    3. Concentraciones media y máxima de ocrelizumab en la leche, así como tiempo transcurrido hasta alcanzar la concentración máxima en la leche, determinados a lo largo de los 60 días siguientes a la primera infusión de ocrelizumab que reciba la madre en el puerperio
    4. Dosis diaria máxima estimada del lactante (DDMeL) por vía oral, calculada como concentración máxima de ocrelizumab en la leche multiplicada por una ingesta estimada de leche materna de 150 ml/kg/día, determinada a lo largo de los 60 días siguientes a la primera infusión de ocrelizumab que reciba la madre en el puerperio
    5. Concentración sérica de ocrelizumab en el lactante determinada 30 (±2) días después de la primera infusión de ocrelizumab que reciba la madre en el puerperio
    6. Títulos medios de respuesta(s) inmunitaria(s) de anticuerpos frente a la vacunación contra dolencias infantiles frecuentes, con dosis completas o parciales administradas antes del año de vida, 1 mes después de la primera dosis de la vacuna triple vírica o en el mes 13 (±14 días) en caso de que no esté previsto administrar esta última
    7. Proporción de lactantes que presenten respuesta humoral positiva (títulos seroprotectores, según se definan para cada vacuna) a las vacunas, determinada 1 mes después de la primera dosis de la triple vírica, o en el mes 13 (±14 días) en caso de que no esté previsto administrar esta última
    8. Tasa e índole de los acontecimientos adversos (AA) en la madre a lo largo del estudio, incluidos los cambios en los resultados clínicos y analíticos
    9. Tasa e índole de los AA en el lactante a lo largo del estudio, incluidas las infecciones y hospitalizaciones
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 30 days after the mother’s first ocrelizumab post-partum infusion
    2. For 1x600 mg: before infusion and at 24 hours (Day 1), 7 days, 30 days and 60 days post-infusion; For 2x300 mg: before infusion 1 and at 24 hours (Day 1), 7 days, 14 days, 15 days (24 hours after infusion 2), 21 days, 30 days and 60 days post-infusion 1
    3-4. Over 60 days after the mother’s first ocrelizumab post-partum infusion
    5. 30 days after the mother’s first ocrelizumab post-partum infusion
    6-7. 1 month after the first dose of MMR vaccine or at month 13 in case MMR vaccine is not planned to be administered
    8-9. Throughout the study and approximately until the infant’s month 13 of life
    1. 30 días después de la primera infusión posparto de ocrelizumab de la madre
    2. Para 1x600 mg: antes de la perfusión y a las 24 horas (día 1), 7 días, 30 días y 60 días después de la perfusión; Para 2x300 mg: antes de la infusión 1 y a las 24 horas (día 1), 7 días, 14 días, 15 días (24 horas después de la infusión 2), 21 días, 30 días y 60 días después de la infusión 1
    3-4 Más de 60 días después de la primera infusión posparto de ocrelizumab de la madre
    5. 30 días después de la primera infusión posparto de ocrelizumab de la madre
    6-7. 1 mes después de la primera dosis de la vacuna MMR o en el mes 13 en caso de que no se planee administrar la vacuna MMR
    8-9. Durante todo el estudio y aproximadamente hasta el mes 13 de vida del bebé
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    exposure effects
    Efectos de Exposición
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Canada
    United States
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    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 is defined as the date of the last assessment (vaccine response titers measured 1 month after the first dose of MMR vaccine, or at month 13 [±14 days] if MMR vaccine is not planned to be administered, for the last infant. The primary analysis will be conducted at the end of the Treatment and Sampling Period (day 60 [±2 days]). The total length of the study, from screening of the first woman to the end of the study, is expected to be approximately 2 years.
    El fin del estudio: fecha de la última evaluación (títulos de respuesta a la vacuna determinados 1 mes después de la primera dosis de la triple vírica, o en el mes 13 [±14 días] si no está previsto administrar dicha vacuna) del último lactante. Se realizará un análisis principal al final del período de tratamiento y toma de muestras (día 60 [±2 días]).Está previsto que la duración total del estudio, desde la selección del primer paciente hasta el final de la investigación, sea de unos 2 años,
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 Yes
    F.1.1Number of subjects for this age range: 20
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    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) No
    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 Yes
    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
    20 infants
    20 bebés
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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)
    None
    Ninguno
    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 Decision2021-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA