1 About SLE
SLE is an autoimmune disease. That means the body’s natural defenses (the immune system) attack healthy cells and tissues. This results in inflammation and damage to joints, skin and other organs.
2 Is the investigational drug approved to treat other diseases?
Yes. The investigational drug is currently approved for the treatment of other conditions. This study will evaluate the investigational drug to see how safe it is and if it can help control symptoms of SLE.
3 Will I experience any side effects from the investigational drug?
Because the investigational drug is still in clinical development, there may be side effects that are not known at this time and there is potential that you may experience side effects. During the informed consent process, the study team will review a description of the side effects and possible discomforts that may occur during the study. Informed consent is used to make sure that you understand the known risks associated with the study. The LOTUS Study is, in part, designed to monitor participants for side effects. If you do experience side effects during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be continuously monitored. Study treatment will be stopped if you or the study doctor have any concerns.
4 Who can take part in the extension period?
The purpose of the extension period is to collect more information about the investigational drug over a 2-year period and to determine whether it is safe, has any side effects, and works in people with SLE. You can only enter the extension period if you have completed the double-blind study treatment period. If you have stopped taking the study drug early or the study doctor believes that taking part is not in your best interests, you will not be able to join the extension period. You will then be asked to return to the study clinic 16 weeks after your last dose of the study drug to undergo study evaluations.
5 What if I want to leave the study early?
It is voluntary to join the study. You can leave the study at any time for any reason. Your decision will not affect any future medical care that you receive. You may also be removed from the study if the study doctor decides that continuing is not in your best interest. If you do decide to leave, you will be asked to return to the study clinic to undergo study evaluations.
6 Do I need to ask my regular doctor before participating in this study?
We encourage you to inform your regular doctor that you are taking part in this clinical research study. There are some medications that are prohibited to take while on the study and your doctor may wish to contact the study staff (with your permission) to request additional information.
7 Will I have to switch doctors?
No. The LOTUS Study will provide short-term study-related care only. Clinical research studies do not provide extended or comprehensive primary health care. At the end of the study, your care will return, in full, to your regular doctor.
8 Will I be compensated for my participation in this study?
You will not be paid for taking part in this study. However, the Sponsor (the company carrying out the study) will pay for local travel/parking expenses to and from the study clinic. Please keep receipts for these expenses. The study drug and all study-related care will be provided without charge. Please refer to the Informed Consent Form for further details.
9 Who will have access to the information collected during the study?
Your personally identifiable information (PII), eg name and address, will not be accessible to anyone who is not directly associated with this study, except with your permission or as required by law. The Sponsor (the company carrying out the study) will not have access to any PII submitted through this website. Any information gained from this study may be used for publishing results. However, this information will be combined with other participant data and will not be used to identify participants.