E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing Multiple Sclerosis |
Esclerosis Multiple Recidivante |
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E.1.1.1 | Medical condition in easily understood language |
Relapsing Multiple sclerosis is characterized by relapses followed by periods of full or partial recovery. |
La esclerosis múltiple recidivante se caracteriza por recidivas seguidas de periodos de recuperación total o parcial. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to assess whether the efficacy of ocrelizumab 600 mg intravenously every 24 weeks is superior to Rebif® as measured by the annualized protocol-defined relapse rate by two years in patients with relapsing multiple sclerosis. |
El objetivo principal de este estudio consiste en evaluar si la eficacia de ocrelizumab 600 mg cada 24 semanas es superior a la de Rebif® según lo determinado mediante la tasa anualizada de recidivas definidas según el protocolo al cabo de dos años en pacientes con esclerosis múltiple recidivante. |
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E.2.2 | Secondary objectives of the trial |
? To evaluate whether the efficacy of ocrelizumab is superior to Rebif®, as reflected by the following measures: ? The time to onset of sustained disability progression for at least 12 weeks during the 96-week comparative treatment period. ? The time to onset of sustained disability progression for at least 24 weeks during the 96-week comparative treatment period. ? The proportion of relapse-free patients by 96 weeks. ? The change in total T2 lesion volume as detected by brain MRI from baseline to Week 96. ? The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI at weeks 24, 48 and 96. ? The change in Multiple Sclerosis Functional Composite Scale (MSFCS) score from baseline to Week 96. ? The change in brain volume as detected by brain MRI from Week 24 to Week 96. |
Evaluar si la eficacia de ocrelizumab es superior a la de Rebif®, según lo determinado mediante las variables siguientes: ? Tiempo hasta la aparición de progresión sostenida de la discapacidad durante un mínimo de 12 semanas en el período de tratamiento comparativo de 96 semanas. ? Tiempo hasta la aparición de progresión sostenida de la discapacidad durante un mínimo de 24 semanas en el período de tratamiento comparativo de 96 semanas. ? Proporción de pacientes sin recidivas al cabo de 96 semanas. ? Variación del volumen total de lesiones en T2 detectadas mediante RM cerebral entre el período basal y la semana 96. ? Número total de lesiones hipertensas en T2 nuevas o que aumenten de tamaño detectadas mediante RM cerebral en las semanas 24, 48 y 96. ? Variación de la puntuación en la Escala funcional compuesta de esclerosis múltiple (MSFCS) entre el período basal y la semana 96. ? Variación del volumen cerebral detectado mediante RM cerebral entre las semanas 24 y 96. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Procedimiento único de resonancia magnética exigido para el proceso de normalización de las resonancias magnéticas en el estudio principal. WA21093 (versión B) del 27.05.2011 Subestudio de Muestras para el banco de muestras clínicas de Roche: para identificar biomarcadores. WA21093 (versión B) del 27.05.2011 |
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E.3 | Principal inclusion criteria |
Male and female patients between ages 18-55 with a diagnosis of relapsing multiple sclerosis At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the year prior to screening (but not within 30 days prior to screening) Patients with EDSS score of 0-5.5 |
Pacientes varones y hembras con edades comprendidas entre los 18 y 55 años con diagnóstico de esclerosis múltiple recidivante. Al menos dos episodios clínicos documentados en los dos últimos años antes de la selección o un episodio clínico en el año anterior a la selección (pero no en los 30 días anteriores a la selección) Pacientes con puntuación EDSS de entre 0 y 5.5 |
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E.4 | Principal exclusion criteria |
Patients with other chronic disease of the immune system, malignancies or other diseases or conditions that could preclude patient from participating in the study Contraindications to or intolerance of oral or i.v. corticosteroids Contraindication to or intolerance of interferon beta-1a (Rebif) Pregnant or nursing women |
Pacientes con otra enfermedad crónica del sistéma inmune, tumor u otra enfermedad o condición que pueda descartar la participación del paciente en el estudio Contraindicaciones o intolerancia a corticoides por vía oral o i.v Contraindicación o intolerancia a interferon beta-1a (Rebif) Mujeres embarazadas o en periodo de lactancia |
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E.5 End points |
E.5.1 | Primary end point(s) |
Annualized protocol-defined relapse rate at |
Tasa anualizada de recidivas definidas según el protocolo |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
? The time to onset of sustained disability progression. ? The time to onset of sustained disability progression. ? The proportion of relapse-free patients. ? The change in total T2 lesion volume as detected by brain MRI. ? The total number of new, and/or enlarging T2 hyperintense lesions as detected by brain MRI. ? The change in Multiple Sclerosis Functional Composite Scale (MSFCS) score. ? The change in brain volume as detected by brain MRI. Additional exploratory endpoint as defined in the protocol |
? Tiempo hasta la aparición de progresión sostenida de la discapacidad ? Proporción de pacientes sin recidivas al cabo de 96 semanas. ? Variación del volumen total de lesiones en T2 detectadas mediante RM cerebral ? Número total de lesiones hipertensas en T2 nuevas o que aumenten de tamaño detectadas mediante RM cerebral ? Variación de la puntuación en la Escala funcional compuesta de esclerosis múltiple (MSFCS) ? Variación del volumen detectado mediante RM cerebral |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Assessments will be made at week 24, 48 and 96 |
Las evaluaciones se realizarán en las semanas 12, 24, 48 y 96 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Doble enmascaramiento |
Double Dummy |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 92 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Belarus |
Bosnia and Herzegovina |
Brazil |
Canada |
Colombia |
Croatia |
Mexico |
Peru |
Russian Federation |
Turkey |
Ukraine |
United States |
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E.8.7 | Trial 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 end of the study has been defined as the date at which the last data point from the last patient, which was required for statistical analysis as defined in Data Analysis Plan (DAP), was received. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |