Defining responders to teriflunomide treatment in Multiple Sclerosis

Lead Investigator: Maria Pia Sormani, University of Genoa
Title of Proposal Research: Defining responders to teriflunomide treatment in Multiple Sclerosis
Vivli Data Request: 9792
Funding Source: None
Potential Conflicts of Interest: Dr. Sormani reports: She collaborated as a consultant with Roche, Biogen, Novartis, Merck. I will declare them in any subsequent publication.

Summary of the Proposed Research:

Multiple sclerosis (MS) is a condition that affects the brain and spinal cord. The coating of the nerves (myelin) is attacked by the body’s own immune system and this causes a wide range of potential symptoms, including problems with vision, and how we move and think. Over 1.8 million people have MS worldwide. If the brain is like a highway with wires carrying messages, having MS is like someone is messing with the wires, this can cause big problems and sometimes leaves permanent damage (disability). Doctors are trying to fix this with new medicines, but they need to know who benefits the most from particular medicines.

Right now, in most clinical studies doctors compare a new medicine to a placebo (pretend) medicine by giving one group of patients the new medicine and one group the placebo, and seeing if the medicines have any effect on the patients. The problem with this is that unless each patient has a period of time where they are taking the new medicine and taking the placebo medicine in turn it can be hard to be sure if the new medicine works. It’s like giving candy to two groups of kids and seeing who likes it more, but you can’t give the same kid both candies!

So, doctors are trying a new method: making a “scorecard” based on things like age, height, and symptoms to predict who might benefit more from the new medicine. It’s like figuring out which kids might like spicy candy based on their favorite colors.

In our study we aim to create a scorecard using the patients’ information collected before they were treated with a new MS medicine called terifluonomide. This medicine is thought to work by dampening down the immune system which is attacking the nerve coating. We will analyse this information along with how they respond to the medicine to see if we can predict who will have the most benefit from it. We hope this will help doctors give the right medicine to the right people.

Requested Studies:

Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO)
Data Contributor: Sanofi
Study ID: NCT00134563
Sponsor ID: NCT00134563

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (TOPIC)
Data Contributor: Sanofi
Study ID: NCT00622700
Sponsor ID: NCT00622700

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis (TOWER)
Data Contributor: Sanofi
Study ID: NCT00751881
Sponsor ID: NCT00751881