Investigator: Dr Matthew Jackson (Consultant Neurologist) Centre number: 814 Contact for queries If you have any questions about this study, you can contact: Daytime: Elspeth Wolfenden on 01494 734312 Out of hours: Pager No. 07623903035 directed to Research Nurse MS unit at the John Radcliffe Wycombe Hospital Queen Alexandra Road High Wycombe Buckinghamshire HP11 2TT Tel: 01494 526 161 www.buckshealthcare.nhs.uk Long term observational study for multiple sclerosis patients using fingolimod You are being invited to take part in an observational study with a medicine, fingolimod (also known as Gilenya), for treating multiple sclerosis. Before you decide whether to take part, you need to understand why the study is being done and what it will involve. This information document is made up of two sections: questions and answers about the study a Consent Form Please take some time to read it carefully, and discuss it with your family, friends and GP if you wish, before making up your mind. If anything in this Information Sheet and Consent Form is not clear, or if you have more questions, please ask the doctor or nurse who gave it to you. About the study: The purpose of this study is to observe patient treatment with fingolimod (Gilenya) or another multiple sclerosis (MS) medication over a period of time to assess long-term safety. The study will record information from patients taking fingolimod (Gilenya) or another MS medication, under the routine medical practice of the clinic/hospital. The study is being organised by Novartis Patient Information and Consent Form, Protocol CFTY720D2406 Page 1 of 9
Questions and answers Why have I been invited to take part? Your doctor has diagnosed you with multiple sclerosis (MS) and you may be suitable to take part in this study. You will be starting or have already started taking fingolimod (Gilenya) or another MS medication. There are expected to be approx. 3000 patients worldwide who take part in this study. Do I have to take part? No it is up to you to decide whether or not you take part. If you do decide to take part, you will be asked to sign the consent form at the back of this document. You will be given a copy of the information sheet and signed consent form to keep. You will still be free to pull out of the study at any time, with or without giving a reason. If you decide to pull out, this will not affect your future treatment and care. Finally, if you decide to take part in the study but lose full mental capacity during the study, your treating doctor may consider keeping you in the study so Novartis can continue to collect medical information on your condition. As you will not be able to agree to continue in the study yourself, your treating doctor/nurse will ask the opinion of a consultee on your behalf. The consultee will be, for example, a legal representative, guardian, relative, carer or friend. The choice of the consultee will be in line with routine hospital/clinic regulations for such cases. If the consultee agrees to provide their opinion they will be given an information sheet, similar to this one, to read and ask questions. If their opinion is you should continue in the study, they will sign a separate consultee declaration form. You will then continue to take part in the study but the consultee is free to pull you out of the study as any time, with or without giving a reason. What will happen to me if I take part? Before you can start the study, your treating doctor and/or nurse will talk to you about the study. If you agree to take part in the study, you will be asked to sign the consent form attached to this leaflet to confirm that you agree to be observed. You will be take part for a minimum of 5 years and a maximum of 8 years depending on when you join the study your treating doctor/nurse will provide you with further information. This is an observational study. This means that your treating doctor and nurse will look after you and treat you following the routine medical practice at the hospital/clinic. This study will not need any additional tests or treatment for your MS to be completed. Novartis will only collect information on your routine tests and visits to the hospital/clinic to treat your MS. You will receive fingolimod (Gilenya) or another MS medication through a hospital prescription by your treating doctor - Novartis will not provide medication to you during the course of your participation. Patient Information and Consent Form, Protocol CFTY720D2406 Page 2 of 9
During your routine hospital/clinic visit your treating doctor/nurse will record your care and responses to fingolimod (Gilenya) or other MS medication in your medical file this will include any side effect you have experienced, any other medications you are taking, and other medical test results including but not limited to vital signs, blood sampling, and eye, lung and heart examinations. Novartis has asked your treating doctor/nurse to provide them with the information collected in your medical file during your routine visits. At your first visit for this study you will be asked for information on yourself, your health, MS history and previous MS treatment. In addition, you may receive your first dose of fingolimod (Gilenya) or other MS medication if you have not already started taking it. You will be monitored for any new symptoms (such as; chest pain, dizziness, palpitations, feeling faint, nausea, vomiting), which your treating doctor/nurse will discuss with you fully. During the study, you will visit the clinic/hospital as recommended by your treating doctor/nurse. This is expected to be a minimum of yearly but visits are likely be more often (e.g. every 3 Months in the first year then every 6 Months thereafter) and in line with the hospital routine care. If your treating doctor changes your MS medication while you are taking part in this study, information can still be collected from your routine visits to the hospital/clinic. Your decision to take part in this part of the study is voluntary. You are free to pull out of the study at any time you will not have to provide a reason if you do not wish to. Your MS treatment will continue as normal and will not be affected if you pull out. What will I have to do? The study will follow the routine practice of the hospital/clinic, therefore the treating doctor and nurse will tell you when to visit and what you will have to do. You will be expected to follow what your treating doctor/nurse recommends and this will include, but not be limited to: Attending all hospital/clinic visits as directed. Taking your medication as directed. Telling your doctor/nurse of any other medication you are taking. Telling your doctor/nurse if you feel unwell or have any unusual symptoms, MS related or not, such as a change in your vision, dizziness, fatigue or a slow or irregular heart rate, or breathing difficulties, liver related adverse events, any infection or symptoms of infection such as fever, chills, nausea or vomiting, or changes in your skin. Telling your doctor/nurse immediately if you feel that your MS symptoms are getting worse. If you are a woman who could become pregnant: The use of fingolimod (Gilenya) in women who are or may become pregnant should only be considered if the potential benefit justifies the potential risk to unborn baby. The risks to an unborn baby or a nursing child from fingolimod (Gilenya) are not known. This drug did cause birth defects in the offspring of rats, but it is currently unknown if there is any risk for the development of defects in an unborn baby during the pregnancy in women. Patient Information and Consent Form, Protocol CFTY720D2406 Page 3 of 9
If you are a woman of childbearing potential who will newly start on fingolimod (Gilenya), it should be confirmed that you are not pregnant or breast-feeding before entering this study. Your treating doctor/nurse will discuss with you effective measures of birth control to avoid pregnancy during and for 2 months after stopping fingolimod (Gilenya) treatment. Should you become pregnant during the study, your treating doctor/nurse will discuss with you whether or not you should remain on fingolimod (Gilenya) based on the potential benefit and whether it justifies the potential risk to the unborn baby. In addition, your treating doctor/nurse will discuss with you the option of participating in an optional pregnancy registry. The aim of this pregnancy registry is to collect information about pregnancy and birth outcomes in women who have been taking fingolimod (Gilenya) just before or during their pregnancy. Your treating doctor/nurse will give you further details should it be necessary. You should not breast-feed while you are taking fingolimod (Gilenya). Fingolimod (Gilenya) can pass into breast milk and there is a risk of serious side effects for a breast-fed baby. Speak with your treating doctor/nurse before breast-feeding while you take fingolimod (Gilenya). What are the possible benefits of taking part? You will receive no direct benefit from taking part in this observational study information will only be collected on what your treating doctor decides to do under the hospital/clinic routine medical practice. However, your taking part may help to gain knowledge on the long-term effects of fingolimod (Gilenya), which may help patients to get better care for their MS in the future. Who cannot take part in this study? If you have private medical or life insurance Please check with your insurer that it is acceptable under the terms of your policy for you to take part in this study. What are the possible side effects and risks of taking part? This study is observational study based on the routine care and practice of your hospital/clinic. As a result, there are no additional risks to taking part in this study. Like all medicines, fingolimod (Gilenya) can cause side effects, although not everybody gets them. Side effects may occur with certain frequencies, which are defined as follows: Very common: Affects more than 1 in 10 patients Common: Affects between 1 and 10 in every 100 patients Uncommon: Affects between 1 and 10 in every 1,000 patients Very common: Infection from flu virus with symptoms such as tiredness, chills, sore throat, joint or muscles aching, fever Headache Patient Information and Consent Form, Protocol CFTY720D2406 Page 4 of 9
Diarrhoea (very loose stool) Back pain Cough Increase levels of a blood test (called Alanine transaminase (ALT)) that can help show liver damage Common: Disease of the lung known as Bronchitis with symptoms such as cough with phlegm, and chest pains Illness of the digestive system and stomach (Gastroenteritis) with symptoms such as vomiting, nausea, diarrhoea, fever Herpes virus infection (shingles or herpes zoster or herpes simplex). Symptoms of herpes zoster may include pain, blisters, numbness of a area. Symptoms of Herpes simplex may include blisters, burning, itching or pain around the mouth or genitals. Slow heartbeat (known bradycardia) A type of abnormal heart rhythm known as atrioventricular block Feeling of pressure and pain in the cheeks and forehead, known as sinusitis Infection from fungi affecting the skin, hair or nails (ringworm) Dizziness Tingling or numbness Migraine (severe headache often accompanied by nausea, vomiting and sensitivity to light) Weakness Itchy, red, burning rash (signs of eczema) Hair loss Itching Weight loss Being short of breath Abnormal liver blood test results that may show damage to the liver Abnormal blood test results that may show damage to body tissues including the liver. Test is for Gamma-glutamyl transferase (GGT). Blood triglyceride (fat) increased Low level of white blood cells (lymphocytes, leucocytes) Depression Eye pain Blurred vision Increase in blood pressure. Uncommon: Some side effects are more uncommon. If you experience any of these, please contact your doctor/nurse straight away: A serious condition of the lung (Pneumonia) with symptoms such as fever, cough, and difficulty breathing Swelling in the back of the eye (Macular oedema) with symptoms such as eye shadows, blind spots and blurred vision, and lack of colour details. Low level of certain white blood cells (neutrophils) Some side effects could be or could become serious. If you experience any side effects tell your treating doctor/nurse immediately. These are not all of the possible side effects of fingolimod (Gilenya) - for more information, please ask your treating doctor or nurse, or refer to the medication leaflet or summary of product characteristics. The other MS medications taken during this study will have their own side effects. For more information, please ask your treating doctor or nurse, or refer to the medication leaflet or summary of product characteristics. Patient Information and Consent Form, Protocol CFTY720D2406 Page 5 of 9
What if new information becomes available during the study? Fingolimod is a licensed treatment for multiple sclerosis. If new information becomes available during this observational study your treating doctor/nurse will update you. What if something goes wrong? This is an observational study following the hospital/clinic routine practice. If you are not happy with the general care you receive during the study, please speak first to your treating doctor or nurse, who will try to resolve the problem. He/she should also tell you about the hospital/clinic standard complaints procedure in case you wish to take the matter further. As this is an observational study, cases that may require insurance cover should be referred to and handled by the hospital/clinic. However, should it be required, Novartis has in place product & public liability insurance to support this type of study where treatment and care is provided by the hospital/clinic only. What happens at the end of the study? You will continue to take MS medication as is required by the routine medical care for your MS. About 6 months after the study ends, your doctor will know the results of the study, and can provide you with information should you wish. Any report that is published about the study will not identify you or any other patient taking part. What information about me will be collected? The information (data) collected in the study will include: personal data information that could be used to identify you, such as your initials and date of birth sensitive personal data information about your health and medical history To protect your right to privacy, there are Data Protection Laws in European Union Member States. These laws control: o o o how personal and sensitive personal data (including your biological samples) is collected how it can be used where it can be passed on to When you give this information to someone (known as the data controller) they must comply with Data Protection Laws and only use the data in ways for which you have given permission. The data controller for the study is Novartis Pharma Services AG (the company organising the study). What will the information be used for? The information collected in the study will be used to find out how safe switching the medication is for treating the condition being studied. The data will be retained for at least 15 years. If and when it is disposed of, this will be done securely. Patient Information and Consent Form, Protocol CFTY720D2406 Page 6 of 9
The results of the study may be used in presentations or published in scientific reports. Any presentation or published report about the study will not name or otherwise identify you. In future, Novartis may wish to use information from the study for future research into the causes and treatment of the condition being studied. This will not include genetic research unless you have signed a separate consent form. Will my taking part in this study be kept confidential? Your data will be collected Your data will be coded and collected on a paper record / directly into a computer at the hospital / clinic. Your name will not be disclosed outside the hospital / clinic. You have the right to check the accuracy of the data held and correct any errors. Your medical records will be checked To make sure the information collected in the study is accurate, it will need to be checked by researchers and authorised persons working on behalf of Novartis and for government health departments. You are asked to give permission for these authorised people to see your medical records. They will keep the information confidential and your rights to privacy will be protected. With your permission, we will let your GP know You are asked to give permission for us to let your GP know that you are taking part in the study. Your doctor may need to contact your GP to obtain more information about you. Please ask your doctor if you would like a copy of any correspondence. Information may be passed on Information from this study may be passed on to government health departments and related companies in countries within and outside Europe (the European Economic Area), for administering this study and for possible further scientific study. In some of these countries, the data protection laws are not as strict as those within the European Economic Area. The information passed on this way will never include your name. Who is organising and paying for this study? The study is being organised and funded by Novartis Pharma Services AG and is being run by the medical staff in the hospital / clinic. Novartis will make payments into your study doctor s hospital research fund to cover the costs of this study. Has the study been approved? Yes. A Research Ethics Committee has reviewed and approved this research study. The Research Ethics Committee includes healthcare professionals as well as non-medical people. All members of the committee are completely independent from anyone organising the study. Patient Information and Consent Form, Protocol CFTY720D2406 Page 7 of 9
Where can I get more information? If you have more questions about this study, you can contact the study doctor whose name and number are on the front page of this Information Sheet and on the Consent Form. What will happen if I don t want to carry on with the study? You are free to withdraw from the study at any time, without giving a reason, and without your medical care or legal rights being affected. If you should decide to leave the study, you should tell the doctor or staff. All data collected up until the date of your withdrawal will be used. You have the right to decide whether data from any assessments after your withdrawal can be used. If you withdraw from the study, researchers, authorised persons from Novartis and the regulatory authorities will still require access to your medical notes to verify the data collected up to the date of your withdrawal. Patient Information and Consent Form, Protocol CFTY720D2406 Page 8 of 9
Investigator: Dr Matthew Jackson (Consultant Neurologist) Centre number: 814 Contact for queries If you have any questions about this study, you can contact: Daytime: Elspeth on 01494 734312 Out of hours: Tel 01494 526161 ask for Neurology Registrar on call. Amersham Hospital Whielden Street Amersham Buckinghamshire HP7 0JD Tel: 01494 434 411 www.buckshealthcare.nhs.uk Long term observational study for multiple sclerosis patients using fingolimod Please initial each box to confirm that you have read, understood and agreed each of the numbered points. 1 I have read and understood this Information Sheet and Consent Form and I have had the time to consider it. I have had the opportunity to ask questions and they have been answered to my satisfaction. 2 I understand that my taking part is voluntary and that I am free to withdraw at any time, without giving any reason, and without my medical care or legal rights being affected and that if I withdraw from the study for any reason, Novartis will use my data up to when I withdraw from the study. 3 I understand that my medical notes may be looked at by authorised persons from Novartis, from the local health authority or from regulatory authorities, where it is relevant to my taking part in this research. I give my permission for these people to have access to my records. I understand that if I withdraw prematurely that my records may need to be accessed after my withdrawal in order to verify data collected while I was in the study. 4 I consent to the collection, use and transfer of personal and sensitive personal data about me, including medical information. 1 2 3 4 5 I understand that Novartis may pass sensitive, personal data, without my name, to regulatory authorities and/or to its subsidiary companies, for administering this study and for future research into the causes and treatment of multiple sclerosis. I understand that these authorities or companies may be in countries within or outside the EEA, and that some of these countries outside the EEA do not have laws regulating the transfer of personal data. I give my permission for such transfer of data. 6 I consent to my GP being told that I am taking part in this study 5 6 7 I agree to take part in the above study. 7 When you have initialled all the above boxes, please complete the first box below (including the date) yourself: Name of patient (CAPITALS): Signature: Date: Name of doctor/nurse taking consent (CAPITALS): Signature: Date: Patient number: Patient s initials: Original to be kept in the study Investigator Folder; Second original or a copy of the original to be given to the patient. The Information Sheet and Consent Form are one entire document and must not be separated. Patient Information and Consent Form, Protocol CFTY720D2406 Page 9 of 9