E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-remitting multiple sclerosis |
Esclerosis múltiple remitente-recurrente |
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E.1.1.1 | Medical condition in easily understood language |
Relapsing-remitting multiple sclerosis |
Esclerosis múltiple remitente-recurrente |
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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 | 17.0 |
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 |
To assess the distribution of IARs by severity grade when Lemtrada is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions |
Evaluar la distribución de las RAI por grado de gravedad al administrar LEMTRADA a pacientes con EMRR medicados según un algoritmo especificado diseñado para manejar las reacciones asociadas a la infusión |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label - Signed written informed consent |
Criterios de inclusión: · Pacientes adultos con EMRR que inicien el tratamiento con LEMTRADA de acuerdo con la ficha técnica local aprobada · Formulario de consentimiento informado (FCI) firmado |
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E.4 | Principal exclusion criteria |
- Previously treated with Lemtrada - Contraindications to Lemtrada according to the labeling in the country - Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label - Currently participating in another investigational interventional study - Any technical/administrative reason that makes it impossible to enroll the patient in the study - Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol - Patient who has withdrawn consent before enrollment (starting from signed informed consent form) - Despite screening of the patient, enrolment is stopped at the study level - Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy - Pregnancy (defined as positive beta-HumanChorionicGonadotropin blood test), breast feeding - Known infection with latent tuberculosis or active Tuberculosis - Known infection with Hepatitis B, Hepatitis C |
Principales criterios de exclusión · Contraindicaciones a la administración de LEMTRADA de acuerdo con la ficha técnica del país · Cualquier contraindicación conocida al tratamiento sintomático utilizado en las directrices sobre el manejo de las infusiones en función de su ficha técnica local aprobada · Pacientes tratados previamente con LEMTRADA · Pacientes que estén participando actualmente en otro estudio de intervención en fase de investigación |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of IARs that are graded mild according to the Common Toxicity Criteria (CTC). An IAR is any adverse event occuring during or within 24 hours of Lemtrada infusion.
Proportion of IARs
Proportion and type of serious IARs
Proportion by type (as defined by clinical symptoms) |
El objetivo principal se evaluará resumiendo: · El número (%) de RAI · El número (%) y el tipo de RAI graves · El número (%) por tipo (según los síntomas clínicos) Todos los resúmenes mostrarán el total general y las estadísticas desglosadas por momento y ciclo de infusión o por gravedad, si procede. Esto incluirá resúmenes del número (%) de RAI desglosado por intervalos de 2 horas desde el inicio de la infusión hasta 2 horas después del final de esta. Una RAI se define como cualquier acontecimiento adverso que aparece durante la infusión de LEMTRADA o en un plazo máximo de 24 horas tras la infusión. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 days after each of the two treatment courses |
30 días después de cada uno de los ciclos de tratamiento |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Guidance for the management of the infusion-associated reactions (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) patients treated with Lemtrada |
Guía para el manejo de las reacciones asociadas a la infusión (RAI) en pacientes con esclerosis múltiple remitente-recurrente (EMRR) tratados con LEMTRADA. |
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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 | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 20 |
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 |
France |
Netherlands |
Spain |
Switzerland |
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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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LVLS |
Última Visita 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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |