Information for patients
PATIENT INFORMATION SHEET
REC ref : 12/LO/0012
Date: 20 December 2012
Version 04
1a. Study lay title: The treatment of rheumatoid arthritis with BiP.
1b. Study scientific title: A First In Human, Double–Blind, Randomised, Placebo-Controlled Study To Investigate The Effects Of BiP In Patients With Rheumatoid Arthritis
2. Invitation paragraph
You are being invited to take part in a clinical trial of a new drug, called BiP, for the treatment of rheumatoid arthritis. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends, relatives and your GP if you wish. Please ask us if there is anything that is not clear or if you would like more information, (contact details given below). Take time to decide whether or not you wish to take part.
3. What is BiP?
BiP is a protein found in the cells of the body of every human being. BiP improves arthritis in animals that have inflammation in their joints similar to that of rheumatoid arthritis.
- What is the purpose of the study?
The purpose of this study is to see if BiP might be a new treatment for rheumatoid arthritis. We will be giving BiP to humans for the first time. The study has three aims:
1. Is BiP safe? In order to ensure safety you will be closely monitored during the course of the study for any possible side effects.
2. What effect does it have on the blood? We will take blood tests regularly during the study to check for safety and also to see if BiP is changing the inflammation tests associated with rheumatoid arthritis.
3. Does BiP improve Rheumatoid Arthritis? During your follow-up the activity of your arthritis will be closely monitored.
5. Why have I been invited?
You have been asked to take part in this study because you have rheumatoid arthritis which is not being completely controlled. Because your arthritis is active we will be able to see if BiP is able to improve your joint inflammation.
6. Do I have to take part?
It is up to you whether or not you decide to join the study. We will describe the study and go through this information sheet. If you agree to take part, we will ask you to sign a consent form. You are free to withdraw from the study at any time, without giving a reason. This would not affect the standard of care you receive, now or in the future.
7. What will happen to me if I take part?
Once you have signed the consent form, we will arrange to see you at a convenient time at Guy’s Hospital for the first visit we call the screening visit. At this visit we will take your medical details, perform a physical examination, a heart trace test called an ECG and blood tests to make sure you will be suitable for the study. If you have not had a chest Xray within three months we will ask you to have one to exclude any chest problems. This Xray has some radiation, the same as 5 days of natural radiation you get from the sun. Once we have satisfactory results we will ask you to come to Guy’s Hospital for the study treatment. As this is the first time BiP has been given to humans we have arranged for the treatment to be given in a specialised unit called Quintiles, which specialises in giving new treatments to people. You are expected to spend two nights at Quintiles. The study treatment will only be given once as an infusion into a vein (often called a drip), which will last one hour. After the infusion, we ask you to stay at Quintiles overnight, so we can closely monitor you to make sure there are no safety concerns. Quintiles are specialists in this area and have many people staying in their unit, so they will look after you.
The treatment you will receive in the infusion will either be one of four doses of BiP or an infusion without drug which we call the placebo. This means BiP will be given to three out of four people in this study. The most important aim of this study is to check the safety of BiP. As day-to-day illnesses, such as colds, can occur at any time, we need to have some people who do not get BiP, to check side effects are not increased in those people who receive BiP. Neither you nor the doctor assessing you will know if you are receiving BiP or the harmless placebo. This is known as a randomised double-blind study. This will mean your response to therapy will not be influenced by knowing you have received a new therapy (the placebo effect). If there is an important reason to find out whether you received BiP, such as serious infection, we can find out from the Pharmacist.
After you return home, we would like to see you regularly at a convenient time at Guy’s Hospital, to check you are well, to assess rheumatoid arthritis activity and take blood tests for safety and to measure inflammation changes. The blood tests will include those usually taken if you are on methotrexate and the amount will vary from three to four tablespoons each visit. The follow-up visits which last about an hour, when we ask about your arthritis and any change in your general health, perform an arthritis activity and general physical examination and perform blood and urine tests.
The first visit will be three days after you have left Qunitiles, and then take place every week for the first 4 weeks, then two more at weeks 8 and 12 after the infusion date. We may ask if we can perform an ultrasound examination of your hand joints, which will take about 15 minutes at screening and weeks 4 and 12. As you may know alcohol can cause abnormal liver function, and as liver function is a very important safety test, we ask that you refrain from consuming alcohol before all the study visits and before attending for the treatment.
Once the study has finished we will discuss your progress with your rheumatologist and you will continue under their care.
8. Travel expenses.
You will be reimbursed for any reasonable travel expenses if necessary.
9. What will I have to do?
If you enter the study we ask you to attend all the arranged visits unless there is a good reason, and to let us know if you have any health problems while on the study. We will ask you to carry on with your regular medications and not to change them unless you contact us first.
10. What are the alternatives for diagnosis and treatment?
.Your rheumatoid arthritis is not totally controlled at present despite taking methotrexate. Your rheumatologist can discuss what other therapies are available, as there are many possibilities. However for some people some drugs may not be available because of restrictions on who can receive them, or they may be considered too unsafe.
11. What are the possible disadvantages and risks of taking part?
The study will ask you to give up some time and also to have extra blood tests, compared to your normal therapy. There is a chance that the study drug may not help your arthritis. This may delay a decision about other therapies that could help your rheumatoid arthritis, although the study only lasts for 12 weeks.
12. What are the side effects of any treatment received when taking part?
Our research to date has shown no evidence that BiP has side-effects in any of the animals that have received it. Since BiP is a copy of a normal human protein that is found in the blood of humans, it is difficult to predict if any side effects could occur. As this is the first time that BiP has been given to humans, safety is the most important consideration and can only be established by performing proper studies such as this. BiP is a protein and sometimes proteins given by a drip (intravenously), can cause an allergic reaction which can cause chills, shivering, rashes, and if more serious breathing trouble and low blood pressure. This is one reason why we give BiP at Quintiles who are experts in this type of treatment. Overseeing your safety while you are in the trial is a Drug Monitoring Committee made up of independent UK rheumatologists with an international reputation in the conduct of clinical trials. If in their opinion there are any serious side effects due directly to BiP then they have the power to stop the trial at once.
13. Ionizing radiation.
This study will include a chest XRay as part of the screening tests, if none have been performed in last 3 months.
14. Harm to the unborn child
No information is available about the effects of BiP in pregnancy or breast-feeding, therefore pregnant, nursing mothers or those trying to conceive will not be a part of the study. We will carry out pregnancy tests in any pre-menopausal women before receiving the infusion, and require that two methods of contraception are used during and for three months after the study.
15. What are the possible benefits of taking part?
There would be no direct clinical benefit to you unless BiP is able to improve rheumatoid arthritis. However you and other patients may benefit in the future if BiP is successful and is introduced into the clinic.
16. What happens when the research study stops?
This study is of a single infusion only. After 12 weeks you will continue to be looked after by your regular rheumatologist, who will be given a report of your progress during the study.
17. What if there is a problem?
Any complaint about the way you have been dealt with during the study or any possible harm you might suffer will be addressed. The detailed information is given in Part 2.
18. Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information about you will be kept confidential.