E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Progressive Multiple Sclerosis (PPMS) Relapsing Multiple Sclerosis (RMS) |
Esclerosis Múltiple Progresiva Primaria (EMPP) Esclerosis Múltiple Recurrente (EMR) |
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E.1.1.1 | Medical 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 |
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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 | 21.1 |
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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063401 |
E.1.2 | Term | Primary progressive 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 |
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 |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary 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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to 44 months |
1. Hasta 44 meses |
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E.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(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 |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
OPEN-LABEL, EXTENSION, ROLLOVER STUDY |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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 | 140 |
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 | Yes |
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 |
Australia |
Brazil |
Canada |
Israel |
Mexico |
New Zealand |
Peru |
Tunisia |
United States |
Austria |
Estonia |
Finland |
France |
Latvia |
Lithuania |
Poland |
Sweden |
Bulgaria |
Netherlands |
Romania |
Spain |
Switzerland |
Czechia |
Germany |
Greece |
Italy |
Belarus |
Belgium |
Croatia |
Hungary |
Norway |
Portugal |
Russian Federation |
Serbia |
Slovakia |
Turkey |
Ukraine |
United Kingdom |
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E.8.7 | Trial 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
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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 |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |