EVOLUTION 1

A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety

The purpose of this study is to learn how safe the study drug, called evobrutinib, is and whether it works. The primary research question is to see whether evobrutinib can reduce relapses, compared to Aubagio® (teriflunomide), a medication already being used to treat RMS. Other aspects being studied are:

how the study drug and Aubagio® (teriflunomide) compare in slowing disability, your health, your tiredness, and your functioning

• how well you are able to tolerate the study drug
• how quickly the study drug is broken down by the body (called pharmacokinetics [PK])
• how substances in the body (called biomarkers) are related to your RMS

We anticipate that approximately 930 people will participate in this study. The study will be conducted in approximately 300 medical centers in about 35 countries globally.

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OCARINA

A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Ocrelizumab Administration in Patients with Multiple Sclerosis

The purpose of this study is to:

• Learn about the safety of ocrelizumab with the new SC formulation at different doses
• Understand the way your body processes this new subcutaneous (SC) formulation of ocrelizumab
• Find the safe dose of SC ocrelizumab that is comparable to the dose of IV ocrelizumab

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FENHANCE

A Phase III Multicenter, Randomized, DoubleBlind, DoubleDummy, ParallelGroup Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis

The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus teriflunomide on patients with RMS.

For this study, 734 male and female participants will be recruited globally. The participants will be aged between 18-55 years.

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OPERA

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The purpose of this research study is to answer the following questions:

• How well does ocrelizumab stabilize, or potentially improve, the signs and symptoms of your MS?
• How safe is treatment with ocrelizumab, and how well do you tolerate ocrelizumab?
• How does ocrelizumab affect your body, and how well does your body break down ocrelizumab?
• How well does ocrelizumab work compared with standard treatment for MS, such as Rebif®?

Is there any way we can predict, with outcome of laboratory and brain magnetic resonance imaging (MRI) scans, how ocrelizumab will help in the clinical course of your disease?

As part of this study, we are also asking your permission to let us take blood samples during the study to test protein biomarkers. Biomarkers are substances in the body that can be used as a sign of a specific disease, condition or method to predict how you respond to or tolerate treatment with ocrelizumab. We may use these samples to:

• Learn more how ocrelizumab works.
• Learn more how MS can affect your body.
• Find new tests that could be used in management of MS and set up standards for these tests.

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ORATORIO

A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis.

Ocrelizumab is a drug which destroys a type of white blood cell called a B-cell, which is believed to play a role in some of the symptoms of MS. It is similar to a drug called rituximab which is already approved for use as a treatment in patients with Non-Hodgkin’s Lymphoma and Rheumatoid Arthritis. Ocrelizumab has a slightly different structure to rituximab and it is thought that this may make it less likely to cause certain side effects.

The purpose of this research trial is to answer the following questions:

How well does ocrelizumab stabilize, or potentially improve the signs and symptoms of your PPMS compared to no active treatment (also known as placebo)?

• How safe is treatment with ocrelizumab and how well do you tolerate ocrelizumab?
• How does ocrelizumab affect your body, and how well does your body break down ocrelizumab?
• Is there any way we can predict, with laboratory information or brain Magnetic Resonance Imaging (MRI) scans, how ocrelizumab will help in the clinical course of your disease?

This research study is being sponsored by F. Hoffmann-La Roche and is under the direction of Dr. Paul Giacomini and the research staff.

This study is looking for 630 people with PPMS. One-third or approximately 210 study participants will receive a placebo, which contains no active drug treatment. Two-thirds or approximately 420 will receive ocrelizumab.

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OBOE

An Open-label, Multicenter, Biomarker Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis.

The purpose of this study is to improve our understanding of how ocrelizumab works. We will collect information on how ocrelizumab changes certain biomarkers in your body. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease.

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ENSEMBLE

An open-label, single-arm study to evaluate the effectiveness and safety of ocrelizumab in patients with early stage relapsing remitting multiple sclerosis

The purpose of this study is to determine whether ocrelizumab is effective at stopping the signs and symptoms of early stage multiple sclerosis.

The results of this study could help Roche acquire Health Canada approval for ocrelizumab in the future. This would allow ocrelizumab to be used in regular medical practice. The data gathered during the study may also be useful for medical professionals and researchers in the future.

For this study, at least 1000 male and female participants will be recruited at 228 sites globally. The participants will be between 18 and 55 years old.

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PASS

A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis

The purpose of this study is to collect information for a period of 10years after your first dose of LEMTRADA, which will include information about your disease, related treatment history, and information to help to obtain a good understanding of potential side effects after treatment with 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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NOVA

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment

The purpose of this study is to test how well the study drug works when given every 6 weeks, compared with the standard 4 weeks (which is currently recommended in adults with RRMS). The study will also look at other things, including:

How safe the study drug is.

What your body does to the study drug (“pharmacokinetics”, or PK).

How the study drug affects your body (“pharmacodynamics”, or PD).

How your body’s immune system reacts to the study drug ‒ some subjects may produce antibodies against the study drug (called “antidrug antibodies”, or ADAs). This will need to be checked repeatedly.

How you are responding to the study drug, by looking at biomarkers (substances in the blood).

Any change in your biology related to the John Cunningham (JC) virus.

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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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