Study Support Materials Cover Sheet

Transcription

1 Study Support Materials Cover Sheet Document Title ESCALATE Patient Brochure Intended Audience This brochure is designed to be given to potentially eligible patients as a take-home summary of key information about the study. The information will help to inform their decision about whether to participate. Stage of Use (Recruitment/Consent/Retention) Awareness raising/pre-recruitment Final Format (Print size/web) DL, 6pp roll-fold, 4 color to both sides, onto 300gsm matt art Item Objectives To briefly outline the purpose of the study To briefly outline what study participation will involve To provide clear instructions about who to contact for further information 1

2 [PAGE 1] [ESCALATE LOGO/STUDY BRANDING] The ESCALATE Study If your multiple sclerosis (MS) has become worse while taking your current MS medication, and you are interested in switching to a new medication, you may be eligible to take part in a clinical research study. Patient Information 2

3 [PAGE 2] What is a clinical research study? Clinical research studies are designed to answer important questions about potential new medications, such as if they are safe and how well they work. All prescribed medications have been tested in clinical research studies. Some clinical research studies take place after a medication has already been approved (licensed), which means that the medication is already available to be prescribed generally. These types of studies help researchers to understand more about how different types of patients respond to a medication after they have switched from a previous therapy. MS: What are my options? If you think your current MS treatment is not helping enough, it is important to contact your doctor or neurologist as soon as possible. They will ask questions to find out about your symptoms and discuss other treatment options. One option might be to join a clinical research study. The ESCALATE Study is researching the use of an already approved medication for patients whose MS has become worse while on their current treatment. It will involve switching from your current MS treatment to the study medication. 3

4 [PAGE 3] What is the ESCALATE Study? The ESCALATE Study is a clinical research study that will look at the health of patients with MS who have switched from their current MS treatment to the study medication. If you agree to take part, your participation will last for just over 2 years. The study will provide researchers with information about the effectiveness of the study medication, which may help doctors better treat people with MS in the future. Study medication will be given as an infusion (which involves slowly injecting the study medication into the body through a vein) once every 4 weeks. The ESCALATE Study will take place in the United States, Germany, and Italy and we are looking for approximately 200 patients to take part. Will I be paid to take part in the study? You will not be paid to take part in this study. However, the cost of the study medication, together with all assessments and study visits, will be paid for by the study sponsor. You may also receive reasonable expenses to cover the cost of traveling to the study center. 4

5 [PAGE 4] What will the ESCALATE Study involve? If you are interested in taking part in this study, you will be invited to a screening visit at the study center. At this visit, a study team member will ask some questions about your health and perform some tests to check whether the study is suitable for you. If you are eligible for the ESCALATE Study, you will need to attend up to 13 assessment visits at the study center, in additional to the study medication infusion visits. This means that you would have approximately 30 study center visits in total, which is equivalent to about once every 4 weeks, for just over 2 years. At these visits, some tests and assessments will need to be done to check your health and to see how well the study medication is working. These include: - Blood tests - Physical examinations - Checks of your temperature, blood pressure, height, and weight - A range of assessments (e.g. walking tests) and questionnaires to assess your physical and mental health, and to see how MS is impacting your life - A magnetic resonance imaging (MRI) scan You will be asked to attend a final study center visit to check your health approximately 3 months after you have finished taking the study medication. Your participation in the ESCALATE Study is entirely voluntary and you can leave at any time without having to give a reason. This decision would not affect your future treatment or your relationship with your doctor. 5

6 [PAGE 5] Can I take part in the ESCALATE Study? You may be able to take part in the ESCALATE Study if you: are years of age have been diagnosed with relapsing MS have been taking any of the following medications for at least the past year, and have had MS disease activity in the past 6 months while you were taking it - Gilenya (fingolimod) - Betaseron (interferon beta-1b) - Rebif (interferon beta-1a - Avonex (interferon beta-1a) - Copaxone (glatiramer acetate) - Extavia (interferon beta-1b) - Tecfidera (dimethyl fumarate) have not used Tysabri (natalizumab) within the past year. Please check with your doctor if you are unsure which medication(s) you have taken in the past year. Should I take part? Taking part in a clinical research study is an important decision, and you may want to discuss it with your family or your usual doctor before you decide. You can also contact a member of the study team to discuss what the study involves and learn more about the study medication. They will make sure all your questions are answered before you join the study. 6

7 [PAGE 6] I m interested: What do I do now? For more information about the ESCALATE Study, or to find out how to take part, please contact a member of the study team using the details below. [Space on layout to insert study center details] [VERSION CONTROL FOOTER] ESCALATE Patient Brochure, Version 1.0, 1 July 2014 [V01 USA01] [PRINT FOOTER] ESCALATE Patient Brochure [V01 USA01] 7