E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Esclerosis múltiple progresiva primaria (EMPP) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063401 |
E.1.2 | Term | Primary progressive multiple sclerosis |
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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 |
Investigar la eficacia del ocrelizumab en comparación con un placebo en pacientes con esclerosis múltiple progresiva primaria, medida por el tiempo hasta la aparición de progresión mantenida de la discapacidad durante el período de tratamiento, definida como un aumento en la EDSS mantenido durante al menos 12 semanas, basado en visitas regularmente programadas. To investigate the efficacy of ocrelizumab compared with placebo in patients with primary progressive multiple sclerosis, as measured by the time to sustained disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 12 weeks. |
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E.2.2 | Secondary objectives of the trial |
Evaluar la eficacia del ocrelizumab en comparación con un placebo, en función de: Tiempo hasta la progresión mantenida de la discapacidad durante el período de tratamiento, definida como un aumento en la puntuación EDSS mantenido durante al menos 24 semanas. Variación en la prueba de ambulación cronometrada de 25 pies entre el período basal y la semana 120. Variación en el volumen total de lesiones en T2 en las imágenes de RM cerebrales desde el período basal hasta la semana 120. Evaluar la seguridad y la tolerabilidad del ocrelizumab en pacientes con esclerosis múltiple progresiva primaria en comparación con un placebo. To evaluate the efficacy of ocrelizumab compared with placebo: ? Time to sustained disability progression over the treatment period, defined as an increase in EDSS that is sustained for at least 24 weeks ? Change in 25-foot timed walk from baseline to Week 120 ? Change in total volume of T2 lesion on MRI scans of the brain |
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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 |
BANCO DE MUESTRAS DE ROCHE (RCR) |
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E.3 | Principal inclusion criteria |
-Diagnóstico de EMPP de conformidad con los criterios revisados de McDonald (2005). -Edad de 18-50 años, inclusive. -Puntuación EDSS en el período de selección de 3,0 a 6,5 puntos -Duración de la enfermedad desde la aparición de los síntomas de EM: a.Menos de 15 años en pacientes con una puntuación EDSS en el período de selección > 5,0. b.Menos de 10 años en pacientes con una puntuación EDSS en el período de selección ≤ 5,0. Para los pacientes de ambos sexos sexualmente activos con capacidad reproductiva, el uso de medios anticonceptivos fiables Dos métodos anticonceptivos durante todo el estudio, incluida la fase de tratamiento activo Y durante 48 semanas después de la última dosis
-Adult patients, 18-50 years of age - Primary Progressive Multiple Sclerosis (according to revised McDonald criteria) - Expanded Disability Status Scale (EDSS) 3.0 to 6.5 points - Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS ? 5.0 - Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose |
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E.4 | Principal exclusion criteria |
- Antecedentes de esclerosis múltiple remitente recidivante, esclerosis múltiple progresiva secundaria o esclerosis múltiple progresiva recidivante en el período de selección -Incapacidad para someterse a una exploración por RM -Presencia conocida de otros trastornos neurológicos -Infecciones activas o recurrentes o crónicas -Antecedentes de cáncer, incluidos tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y carcinomas espinocelulares in situ de la piel y carcinomas in situ del cuello uterino extirpados y resueltos, con bordes limpios documentados en la anatomía patológica). Tratamiento previo con fármacos que actúan sobre los linfocitos B (por ejemplo, rituximab, ocrelizumab, atacicept, belimumab u ofatumumab). -Cualquier tratamiento previo con alemtuzumab (Campath), anticuerpos anti-CD4, cladribina, ciclofosfamida, mitoxantrona, azatioprina, micofenolato mofetilo [MMF], ciclosporina, metotrexato, radiación corporal total o trasplante de médula ósea. History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening - Contraindications for Magnetic Resonance Imaging (MRI) - Known presence of other neurologic disorders - Known active infection or history of or presence of recurrent or chronic infection - History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved) - Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) - Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation |
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E.5 End points |
E.5.1 | Primary end point(s) |
Aumento en la EDSS mantenido durante al menos 12 semanas, basado en visitas regularmente programadas. Time to onset of sustained disability progression, defined as an increase in Expanded Disability Status Scale (EDSS) score that is sustained for at least 12 weeks from baseline to sustained disability progression |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | 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.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 105 |
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 | Information not present in EudraCT |
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 |
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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
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Fecha en que se reciba el último dato del último paciente. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |