FENHANCE

Une étude de phase III multicentrique, randomisée, à double insu, double placebo, à groupes parallèles pour évaluer l’efficacité et l’innocuité du fénébrutinib par rapport au tériflunomide chez des patients adultes atteints de sclérose en plaques cyclique

Le but de cette étude est de comparer les effets, bons ou mauvais, du fénébrutinib par rapport au tériflunomide chez des patients atteints de SPC.

Pour cette étude, 734 participants hommes et femmes seront recrutés dans le monde. Les participants seront âgés de 18 à 55 ans.

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INNODEM EYE TRACKING

Development and Validation of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis

This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.

This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.

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OLERO

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

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ENSEMBLE

Étude menée sans insu, avec un seul groupe de traitement, visant à évaluer l’efficacité et l’innocuité de l’ocrélizumab chez des sujets atteints de sclérose en plaques récurrente-rémittente au stade précoce s

Le but de cette étude est d’évaluer si l’ocrélizumab est efficace pour arrêter les signes et symptômes de la sclérose en plaques au stade précoce.
Au moins 1000 participants, hommes et femmes, prendront part à cette étude dans environ 228 centres d’études dans le monde. Les participants à l’étude seront âgés de 18 à 55 ans.

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PASS

Étude prospective, multicentrique, observationnelle effectuée après l’autorisation de mise sur le marché afin d’évaluer le profil d’innocuité à long terme du traitement par LEMTRADAMC (alemtuzumab) auprès de patients atteints d’une forme rémittente de la sclérose en plaques

Le but de cette étude est de recueillir des renseignements pendant une période de dix ans après l’administration de la première dose de LEMTRADA, ce qui comprend des renseignements sur la maladie dont vous êtes atteint, les antécédents thérapeutiques qui y sont associés et des renseignements pour aider à bien comprendre les effets indésirables qui pourraient survenir après le traitement par LEMTRADA.

MAGNIFY

A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis

The purpose of this study is mainly to look at onset of action of Mavenclad® in the treatment of MS. This means we want to look at how quickly it starts working. The study will also look at the effectiveness of Mavenclad®, how it affects your immune system, and how safe it is (i.e., if there are any side effects)..

For this study, 300 male and female participants will be recruited at approximately 100 sites across Europe (including, but not limited to Austria, Denmark, Finland, France, Germany, Italy, Norway, The Netherlands, Spain, Sweden, Belgium, Czech Republic, Switzerland, the United Kingdom), as well as Israel, Australia and Canada. The participants will be aged 18 years and over.

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ALITHIOS

A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis

This research study will try to answer to the following questions:

· How well does ofatumumab work in reducing relapses, disease worsening, and brain lesions seen on magnetic resonance imaging (MRI) compared to teriflunomide?

· How safe is treatment with ofatumumab, and how well is ofatumumab tolerated?

· How does ofatumumab affect the body?

· Is there a way to predict how ofatumumab will help in the course of MS from results of special laboratory tests and MRI scans?

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TOP

Tysabri® Observational Program

TOP is an epidemiological observational study of participants receiving natalizumab, with each participant to be followed for up to 15 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of Tysabri with marketed use, and the impact of treatment on disability in particular by comparing the results with prospectively determined controls from established databases.

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