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 | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 assess the health related quality of life (HRQoL) through the MSQOL-54 scale in relapsing multiple sclerosis subjects treated with Mavenclad® for 2 years (24 months) |
Evaluar la calidad de vida relacionada con la salud (health related quality of life, HRQoL), mediante la escala MSQoL-54, en sujetos con esclerosis múltiple recidivante tratados con Mavenclad® durante 2 años (24 meses) |
|
E.2.2 | Secondary objectives of the trial |
To assess treatment satisfaction through the TSQM v1.4 questionnaire in relapsing multiple sclerosis subjects at 6 months of treatment |
Evaluar la satisfacción con el tratamiento, mediante el cuestionario TSQM v1.4, en sujetos con esclerosis múltiple recidivante a los 6 meses de tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or female subjects >= 18 years old; • Highly active RMS as defined by: - One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs); - Two or more relapses in the previous year, whether on DMD treatment or not; • EDSS score ≤5.0 |
- Varones o mujeres >= 18 años - Esclerosis múltiple recidivante de elevada actividad, definida por: - Una recidiva en el año anterior y al menos una lesión en T1 Gd+ o bien 9 o más lesiones en T2 durante el tratamiento con otros fármacos modificadores de la esclerosis múltiple (disease modifying drugs, DMD) - Dos o más recidivas en el año anterior, con o sin tratamiento con modificadores de la esclerosis múltiple - Puntuación EDSS <=5,0 |
|
E.4 | Principal exclusion criteria |
Positive hepatitis C or hepatitis B surface antigen test and/or core antibody test for immunoglobulin G (IgG) and/or immunoglobulin M (IgM) • Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result • Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids • History of tuberculosis, presence of active tuberculosis, or latent tuberculosis • Presence of PML in MRI • Active malignancy and history of malignancy • Hypersensitivity to Mavenclad® or to any of the excipients listed in the SmPC • Presence or suspect of PML or other (than MS) major Central Nervous System disease clinically diagnosed or evidences in screening MRI • Moderate or severe renal impairment (creatinine clearance <60 mL/min) |
- Resultado positivo en las pruebas de hepatitis C o del antígeno de superficie del virus de la hepatitis B y/o de anticuerpos contra el antígeno central del virus de la hepatitis B (IgG y/o IgM) - Presencia o antecedentes de trastornos por deficiencias inmunitarias, lo que incluye un resultado positivo del virus de la inmunodeficiencia humana (human immunodeficiency virus, HIV) - En tratamiento inmunosupresor o mielosupresor actual con, por ejemplo, anticuerpos monoclonales, metotrexato, ciclofosfamida, ciclosporina o azatioprina, o uso prolongado de corticosteroides - Antecedentes de tuberculosis, presencia de tuberculosis activa o tuberculosis latente - Evidencia de leucoencefalopatía multifocal progresiva (progressive multifocal leukoencephalopathy, PML) en la resonancia magnética - Neoplasia maligna activa - Hipersensibilidad a Mavenclad® o a cualquiera de los excipientes listados en la ficha técnica - Presencia o sospecha de PML u otra (de la EM) enfermedad del Sistema Nervioso Central clínicamente diagnosticada o evidencias en la prueba de MRI - Insuficiencia renal moderada o grave (aclaramiento de creatinina <60 ml / min |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in MSQoL-54 at 24 months compared to baseline |
Cambios en MSQoL-54 a los 24 meses en comparación con el Basal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
at 24 months compared to baseline |
a los 24 meses en comparación con el Basal |
|
E.5.2 | Secondary end point(s) |
Treatment satisfaction assessed by TSQM v1.4 at 6 months |
- Satisfacción con el tratamiento, evaluada mediante TSQM v1.4, a los 6 meses |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
at 6 months |
a los 6 meses |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 95 |
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 |
Australia |
Austria |
Belgium |
Czech Republic |
Denmark |
Finland |
France |
Greece |
Hungary |
Israel |
Italy |
Lithuania |
Netherlands |
Norway |
Poland |
Portugal |
Slovakia |
Spain |
Sweden |
Switzerland |
United Kingdom |
|
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
|
The end of the trial is defined as the last subject’s End of Trial visit. |
El final del ensayo se define como la última visita del ensayo del último sujeto |
|
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 | 9 |
E.8.9.1 | In the Member State concerned days | 24 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |