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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   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).

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    EudraCT Number:2021-005746-15
    Sponsor's Protocol Code Number:MN43964
    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:2022-05-10
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-005746-15
    A.3Full title of the trial
    A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
    Estudio de prolongación multicéntrico, de un solo
    grupo, abierto y de extensión para evaluar la seguridad
    y la eficacia a largo plazo de ocrelizumab en pacientes
    con esclerosis múltiple
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients with Multiple Sclerosis
    Wstudio de continuación para evaluar la seguridad y eficacia a largo plazo de ocrelizumab en pacientes con esclerosis múltiple
    A.3.2Name or abbreviated title of the trial where available
    OLERO (Open-Label Extension Roll Over)
    A.4.1Sponsor's protocol code numberMN43964
    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 SponsorRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    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. Hoffman-La Roche Ltd.
    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.5.4Telephone number+34637 32 02 90
    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. name Ocrevus
    D. 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.3.1Product nameocrelizumab 300mg/10ml
    D.3.2Product code RO4964913/F07
    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.3.9.4EV 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. 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
    Primary Progressive Multiple Sclerosis (PPMS)
    Relapsing Multiple Sclerosis (RMS)
    Esclerosis Múltiple Progresiva Primaria (EMPP)
    Esclerosis Múltiple Recurrente (EMR)
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis (MS) is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance
    La EM es una afección que puede afectar el cerebro y la médula espinal y causar síntomas potenciales, incluidos problemas con la visión, movimiento de brazos o piernas, sensación o equilibrio
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive 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 the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies
    Evaluar la seguridad a largo plazo de ocrelizumab en participantes diagnosticados con EM que se inscribieron previamente en estudios pivotales de fase III patrocinados por Roche
    E.2.2Secondary objectives of the trial
    To evaluate the longer-term efficacy of ocrelizumab in participants diagnosed with MS who were previously enrolled in Roche-sponsored Phase III pivotal studies
    Evaluar la seguridad a largo plazo de ocrelizumab en participantes diagnosticados con EM que se inscribieron previamente en estudios pivotales de fase III patrocinados por Roche
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
    • For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
    • Elegibilidad previa y participación previa en uno de los estudios pivotales patrocinados por Roche WA21092, WA21093 o WA25046 con el participante recibiendo ocrelizumab como medicamento en investigación (IMP) o en seguimiento de seguridad después de la interrupción del tratamiento
    • Para mujeres participantes en edad fértil: compromiso de permanecer en abstinencia (abstenerse de tener relaciones heterosexuales) o usar un método anticonceptivo adecuado y aceptable durante el período de tratamiento y durante al menos 6 meses o más si la etiqueta local es más estricta después de la dosis final de ocrelizumab, como aplicable en el prospecto de ocrelizumab
    E.4Principal exclusion criteria
    • Concurrent participation in any clinical trial (other than the Parent study)
    • Unable or unwilling to comply with the requirements of the protocol
    • Participación simultánea en cualquier ensayo clínico (que no sea el estudio principal)
    • No poder o no querer cumplir con los requisitos del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
    1. Incidencia y gravedad de los eventos adversos, con la gravedad determinada de acuerdo con los Criterios de Terminología Común para Eventos Adversos del Instituto Nacional del Cáncer versión 5.0 (NCI CTCAE v5.0)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to 44 months
    1. Hasta 44 meses
    E.5.2Secondary end point(s)
    1. Change in Expanded Disability Status Scale (EDSS) score over time
    2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time
    3. The number of T1 lesions and number of new or enlarging T2 lesions
    4. The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume
    1. Cambio en la puntuación de la Escala Ampliada del Estado de Discapacidad (EDSS) a lo largo del tiempo
    2. Cambio en la prueba de clavija de 9 hoyos (9HPT) y la prueba de caminata de 25 pies cronometrada (T25FWT) a lo largo del tiempo
    3. Número de lesiones T1 y el número de lesiones T2 nuevas o en aumento
    4. Cambio en el volumen total de las lesiones T2 y en el volumen total de las lesiones T1 sin realce
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. Week 0, 24, 48, 72, 96, 120, 168
    1-4. Semana 0, 24, 48, 72, 96, 120, 168
    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. 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 Yes
    E. trial design description
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA140
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    New Zealand
    United States
    Russian Federation
    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
    A participant is considered to have completed the study if he or she has completed all phases of the study, including the safety follow-up or the discontinuation visit. The end of this study is defined as the date of the last visit of the last participant in the study completing the final safety follow-up or the discontinuation visit.
    Se considera que un participante ha completado el estudio si ha completado todas las fases del estudio, incluido el seguimiento de seguridad o la visita de interrupción. El final de este estudio se define como la fecha de la última visita del último participante en el estudio que completó el seguimiento de seguridad final o la visita de interrupción
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1.1In 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: 1300
    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 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 state71
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 684
    F.4.2.2In the whole clinical trial 1300
    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)
    The Sponsor will offer continued access to Roche IMP (ocrelizumab) to eligible participants in accordance with the Roche Global Policy on Continued Access to IMP. A participant will be eligible to receive ocrelizumab after completing the study if all conditions are met. The Roche Global Policy on Continued Access to IMP is available at the following website: www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    El sponsor ofrecerá acceso continuo a Roche IMP (ocrelizumab) a los participantes elegibles de acuerdo con la Política Global de Roche sobre Acceso Continuo a IMP. Un participante será elegible para recibir ocrelizumab después de completar el estudio si se cumplen todas las condiciones. La Política global de Roche sobre acceso continuo a IMP está disponible en el siguiente sitio web: www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-08
    P. End of Trial
    P.End of Trial StatusOngoing
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