We do not know which medications are best to use in early Multiple sclerosis. We have a problem and we invite you to be part of the solution. Without patients getting involved in clinical trials like DELIVER MS and others, we cannot make any progress.
We now have well over a dozen disease modifying therapies available for the treatment of MS. All of these treatments are safe and already approved for use in MS. The availability of so many effective treatments for MS represents a really positive step forward. But it also brings with it a challenge – how to choose the right one. There are two commonly used approaches to MS treatment: escalation and early highly-effective therapy. In “escalation” we start with safer, less powerful medications and move up to stronger medications if needed. With “early highly effective” we start with the more powerful, perhaps riskier, medications from the start. They both have their merits, making them both very reasonable options. Your neurologist, and indeed the entire field of MS, does not know which approach is most likely to keep you feeling at your best in the future. Part of the uncertainty comes from not being able to predict how severe your MS will be in the future. We are asking you to take part in a study that will help us better understand how we should be using these two treatment approaches for individuals with MS in the future.
In consenting to take part in this study, you would be agreeing to have your initial treatment approach decided at random. You would be allocated either to an escalation approach, or to receive an early highly-effective therapy approach. Unlike some studies, in this study you would be told about which group you were allocated to. This will allow you the opportunity to choose, with the help of your neurologist, the medication from each category that you feel will suit you best. We are only allocating the approach that you start out on. After that, all of the care you receive will be just as normal, meaning that you will be free to change treatment, in discussion with your neurologist, for any reason, at any time. Taking part in the study will not delay you starting on treatment. This is not a study of a new drug, but we are testing the timing of the right approach. It just means that during the first 3 years of your treatment you will have slightly more regular check ups with your MS team, to find out how the medication is suiting you and to use MRI scanning to look at the effects. You and your neurologist will be able to use this information to continue to make informed choices about the best treatment for you. If you or your neurologist feel you’d prefer to switch disease modifying agents during the study, that is absolutely fine – in fact, that’s exactly the sort of thing we wish to understand – when people choose to switch and why.