E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MULTIPLE SCLEROSIS |
SCLÉROSE EN PLAQUES |
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E.1.1.1 | Medical condition in easily understood language |
MULTIPLE SCLEROSIS |
SCLÉROSE EN PLAQUES |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 study the links between early changes visible on diffusion MRI and response to treatment with Tysabri for 2 years |
Etudier les liens entre les changements précoces visibles à l’IRM de diffusion et la réponse au traitement par Tysabri à 2 ans |
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E.2.2 | Secondary objectives of the trial |
Compare the evolution of diffusion MRI data to volumetric data |
Comparer l’évolution des données de l’IRM de diffusion aux données volumétriques |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient > 18
Patient with Multiple Sclerosis in the relapsing form and eligible for Tysabri treatment |
Patient majeur
Patient atteint de sclérose en plaque sous la forme rémittente et éligible à un traitement par Tysabri
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E.4 | Principal exclusion criteria |
Patient not eligible for Tysabri treatment
Contraindicayion to MRI
Pregnancy (women of childbearing age without effective contraception)
Nursing |
Patient non éligible à un traitement par Tysabri
Contre indication à l’IRM
Grossesse (femme en âge de procréer en l’absence de contraception efficace)
Allaitement
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E.5 End points |
E.5.1 | Primary end point(s) |
Compare diffusion MRI before and after the initiation of treatment with Tysabri (2 years versus baseline) using: the fractional anisotropy in the population of responders and non-responders patients |
Comparer l’IRM de diffusion avant et après l’initiation du traitement par Tysabri (à 2 ans versus ligne de base) en utilisant: l’anisotropie fractionnelle dans la population de patients répondeurs et chez les patients non répondeurs
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 years after the initiation of Tysabri treatment |
2 ans après l'initiation du traitement |
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E.5.2 | Secondary end point(s) |
Compare diffusion MRI before and after initiation of treatment with Tysabri. In addition to fractional anisotropy (primary endpoint), mean diffusivity and parameters of axial and radial diffusivity will be compared.
The data of MRI follow-up will be analyzed and the following criteria will be studied: total brain volume, volume of white and gray matter, total volume of FLAIR hyper intensity, number of gadolinium-enhancing lesions on T1-weighted and maps coefficients apparent diffusion (ADC) and anisotropy of the white matter
Correlation of the evoloution of data diffusion MRI (FA and ADC) to the evolution of volumetric data in T1 and the evolution of volumetric data hyperintensity on FLAIR sequence |
Comparer l’IRM de diffusion avant et après l’initiation du traitement par Tysabri en utilisant: en plus de l’anisotropie fractionnelle (critère primaire), la diffusivité moyenne, les paramètres de diffusivité axiale et radiale.
Les données des IRM de suivi seront analysées et les critères suivant étudiés : volume cérébral total, volume des substances blanche et grise, volume totale de l’hyper intensité FLAIR, nombre de lésions rehaussées par gadolinium avec pondération en T1 et les cartes de coefficients de diffusion apparent (ADC) et d’anisotropie de la substance blanche
Corrélation de l’évolution des données de l’IRM de diffusion (FA et ADC) à l’évolution des données volumétriques en T1 et à l’évolution des données volumétriques de l’hypersignal à la séquence FLAIR. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 years after the initiation of Tysabri treatment |
2 ans après l'initiation du traitement |
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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 | No |
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 | 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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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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 | 1 |
E.8.9.1 | In the Member State concerned days | |