Help us fight multiple sclerosis and learn about side effects. Information about the MITIGATE clinical study for you and your family TF-US-0505

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1 Help us fight multiple sclerosis and learn about side effects Information about the MITIGATE clinical study for you and your family

2 Welcome Today we d like to tell you about MITIGATE. The MITIGATE clinical study will aim to improve the treatment of relapsing multiple sclerosis (MS). But we need your help. We re looking for 550 people to take part. Among other things, participants must: Be at least 18 years old Have relapsing MS Not have taken anti-allergy medications in the last month Not have a history of significant gastrointestinal problems (such as irritable bowel syndrome) If this sounds like you, please take a few minutes to read this short leaflet. It will tell you why we re conducting the study and what participating in the study involves. If you have any questions or would like to join, please contact the study team. Clinical studies help improve healthcare Each year, thousands of people take part in clinical studies. Clinical studies are highly regulated scientific investigations that help us improve healthcare. They do this by: Testing potential new medications, devices and procedures Exploring new uses for approved medications Testing new versions of approved medications Every study follows a protocol. This is a plan that states the study s aim, what happens during the study and how each participant s health will be monitored. Such plans are reviewed and approved by independent groups before the study begins.

3 The need for the MITIGATE study TECFIDERA (dimethyl fumarate) is an approved treatment for relapsing MS. But when some people start to take it, they experience gastrointestinal problems such as nausea. The MITIGATE study will investigate a possible solution. MITIGATE will ask whether giving people TECFIDERA plus an approved asthma medication during the study period can reduce the severity of any gastrointestinal problems. We think it might because this medication has previously been shown to treat eosinophilic gastroenteritis an inflammatory disease of the gastrointestinal tract. The MITIGATE study plan About 18 weeks Screening period (around 2 weeks) You ll visit a study clinic so we can make sure you and the study are a good fit TECFIDERA-gastrointestinal monitoring period (up to 4 weeks) Group 1 (up to 8 weeks) plus the approved asthma medication once a day Group 2 (up to 8 weeks) plus a placebo (an inactive medication) once a day Group 1 and 2 (up to 2 weeks) Follow-up telephone interview (2 weeks after your final dose) We ll call you to ask you a few simple questions about your health TECFIDERA, the approved asthma medication and the placebo are all tablets or capsules. A placebo is used so we can make sure that any changes in gastrointestinal side effects seen are due to the approved asthma medication alone. You wouldn t be able to choose (or be told) your group, but all participants will receive the same level of care.

4 How we would monitor your health During the study, we d monitor your health in two ways. Firstly, we d ask you to use an electronic diary each day to record any gastrointestinal side effects and medications you took for them. We d show you how to use the diary at the start of the study. Secondly, the study team will conduct various assessments at pre-scheduled time points. These assessments (which are vital for both your safety and the outcome of the study) may include: Questions about your medical history and general health Questions about any other medications you may be taking Questions about any side effects you may have experienced Electronic diary review Vital signs examination Pregnancy testing Blood tests For most participants, this will mean a visit to a study clinic once every 1 to 2 weeks. However, we might be able to carry them out at your home or office the study team can tell you whether this option is available to you. If you had to miss one of these appointments, you d need to contact us as soon as possible to reschedule. A few final things Will my health improve if I take part? We can t guarantee that taking part in this study will improve your MS or reduce the severity of any gastrointestinal problems that may be related to TECFIDERA. You may feel better, worse or the same. But please be reassured that participants will be monitored closely and you d be able to call the study team for advice at any time. Do I have to join this study? Taking part in this clinical study is a voluntary decision. If you decide not to take part, your future healthcare choices will not be affected. You may also leave the study at any time (even after you ve started treatment). What will this cost me? All study-related medications and procedures will be provided at no cost. Reimbursement for studyrelated costs (such as travel) may also be available.

5 Contact the study team To learn more about this study or to schedule a face-to-face appointment, please contact the study team. We ll be happy to answer any questions that you might have. CONTACT DETAILS: MITIGATE_Brochure_V1_27 May 15_US English