E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing Multiple Sclerosis |
Esclerosis múltiple recidivante. |
|
E.1.1.1 | Medical condition in easily understood language |
Relapsing Multiple Sclerosis |
Esclerosis múltiple recidivante. |
|
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 | 10048393 |
E.1.2 | Term | Multiple sclerosis relapse |
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 the study is to evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment. |
El objetivo principal de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de BIIB017 en sujetos tratados originalmente en el estudio 105MS301 que continúan el tratamiento con BIIB017. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to describe long-term MS outcomes in subjects originally treated in Study 105MS301 who continue BIIB017 treatment. |
Los objetivos secundarios de este estudio son describir los resultados de EM a largo plazo en sujetos tratados originalmente en el estudio 105MS301 que continúan el tratamiento con BIIB017. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Subjects who participated in Study 105MS301, who completed the study treatment and visit schedule through Week 96. 3. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment. |
1. Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado, firmando y fechando el documento correspondiente, así como de autorizar la utilización de información sanitaria protegida (ISP) conforme a la legislación nacional y local de confidencialidad de los datos del paciente.
2. Los sujetos que hayan participado en el estudio 105MS301 y hayan completado el tratamiento del estudio y el calendario de visitas hasta la semana 96.
3. Los sujetos con capacidad de procrear deben utilizar un método anticonceptivo eficaz durante el estudio y estar dispuestos a continuar su uso durante tres meses después de la última dosis del tratamiento del estudio. |
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E.4 | Principal exclusion criteria |
1. Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301. 2. Subjects with any significant change in medical history, including laboratory tests, or a current clinically significant condition that in the opinion of the Investigator would have excluded the subject from participation in Study 105MS301. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment including: - Presence of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study. - Presence of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). - Clinically significant laboratory abnormalities (hematology and blood chemistry) on the most recently available test of Study 105MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in protocol 105MS301 are exclusionary. 3. Female subjects who are currently pregnant (as reflected by a positive pregnancy test at the Week 96 Visit of Study 105MS301/Baseline Visit), who are currently breastfeeding, or who are considering becoming pregnant while in the study. 4. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol. 5. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment. |
1. Los sujetos para los que hayan transcurrido más de 6 semanas desde la finalización de la visita de la semana 96 en el estudio 105MS301.
2. Los sujetos que tengan cualquier cambio significativo en su historia clínica, incluidas las pruebas de laboratorio, o una afección actual clínicamente significativa que, en la opinión del investigador, habría excluido al sujetos de participar en el estudio 105MS301. El investigador debe volver a determinar si el sujeto está médicamente apto para participar y considerar cualquier factor que podría impedir el tratamiento, incluidos: Presencia de cualquier enfermedad cardíaca, endocrina, hematológica, hepática, inmunológica, metabólica, urológica, pulmonar, neurológica, dermatológica, psiquiátrica, renal u otra enfermedad importante que sea clínicamente significativa (conforme al criterio del investigador) y que impediría la participación en un ensayo clínico. Presencia de una neoplasia maligna, incluidos tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y espinocelulares de la piel que hayan sido extirpados completamente y se consideren curados). Resultados anormales de las pruebas de laboratorio (hematología y bioquímica) clínicamente significativos en la prueba más reciente disponible del estudio 105MS301, conforme al criterio del investigador. Los hallazgos de laboratorio para los que es obligatorio interrumpir el tratamiento del estudio que se definen en el protocolo 105MS301 son excluyentes.
3. Las mujeres que estén actualmente embarazadas (que hayan tenido un resultado positivo en la prueba de embarazo de la visita de la semana 96 del estudio 105MS301/ visita basal), que estén actualmente en período de lactancia o que estén considerando la posibilidad de quedarse embarazadas durante el del estudio.
4. Negativa o imposibilidad de cumplir los requisitos del protocolo, incluida la presencia de cualquier circunstancia (física, mental o social) que pueda afectar a la capacidad del sujeto para cumplir el protocolo.
5. Cualquier otro motivo no especificado que, en opinión del investigador o de Biogen Idec, haga al sujeto no adecuado para el reclutamiento. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints include the incidence of AEs, serious AEs (SAEs), and discontinuations of study treatment due to an AE, as well as the incidence of laboratory abnormalities. |
Los criterios de valoración incluyen la incidencia de AA, AAG y las interrupciones del tratamiento del estudio debidas a un AA, así como la incidencia de resultados anormales de laboratorio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
As Necessary |
Según sea necesario. |
|
E.5.2 | Secondary end point(s) |
Relapse outcomes: The annualized relapse rate (ARR) The proportion of subjects who relapse MRI outcomes: The total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans The number of new active lesions on brain MRI scans The total number of new T1 hypointense lesions on brain MRI scans The number of Gadolinium (Gd)-enhancing lesions on brain MRI scans The volume of T2 hyperintense lesions on brain MRI scans The volume of T1 hypointense lesions on brain MRI scans The volume of Gd-enhancing lesions on brain MRI scans Whole brain atrophy Disability outcomes: The degree of disability as measured by the EDSS Disability progression (as measured by at least a 1.0 point increase on the EDSS from baseline EDSS > = 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks). Cognitive function as reflected by the SDMT Quality of Life outcomes: The MSIS-29 physical score The SF-12 The Euro Quality of Life (EQ-5D) Other outcomes: The number of relapses requiring intravenous (IV) steroid use The number of MS-related hospitalizations Percent of subject-reported treatment satisfaction |
Resultados de recidivas: - La tasa anualizada de recidivas (TAR) - Proporción de sujetos con recidiva Resultados de RM: - El número total de lesiones hiperintensas en T2 nuevas o que han crecido en las RM cerebrales - El número de nuevas lesiones activas en las RM cerebrales - El número total de lesiones hipointensas en T1 nuevas en las RM cerebrales - El número de lesiones realzadas con gadolinio (Gd) en las RM cerebrales - El volumen de las lesiones hiperintensas en T2 en las RM cerebrales - El volumen de las lesiones hipointensas en T1 en las RM cerebrales - El volumen de las lesiones realzadas con Gd en las RM cerebrales - Atrofia cerebral total Resultados de discapacidad: - El grado de discapacidad medido con la escala EDSS - Progresión de la discapacidad (medida por un aumento de al menos 1,0 puntos en la escala EDSS con respecto al valor basal de EDSS > = 1,0 que se mantenga durante veinticuatro semanas, o un aumento de al menos 1,5 puntos en la escala EDSS con respecto a un valor basal = 0 que se mantenga durante veinticuatro semanas) - Función cognitiva medida con la SDMT. Resultados de la calidad de vida: - Puntuación física de la escala MSIS-29 - El SF-12 - El cuestionario EuroQoL de calidad de vida (EQ-5D). Otros resultados: - El número de recidivas que requieren el uso de esteroides intravenosos (i.v.) - El número de hospitalizaciones relacionadas con la EM - Porcentaje de satisfacción con el tratamiento informada por los sujetos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As Necessary |
Según sea necesario. |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
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 | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 99 |
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 |
Belgium |
Bulgaria |
Canada |
Chile |
Colombia |
Croatia |
Czech Republic |
Estonia |
France |
Germany |
Greece |
India |
Latvia |
Mexico |
Netherlands |
New Zealand |
Peru |
Poland |
Romania |
Russian Federation |
Serbia |
Spain |
Ukraine |
United Kingdom |
United States |
|
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
|
LPLV |
Última visita del último paciente. |
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |