FREQUENTLY ASKED QUESTIONS

  • Why do we need clinical research studies?
    • Clinical research studies are important to understand more about whether a potential treatment may be better than current treatments. Clinical research studies also help us learn more about the side effects of a potential treatment. Thousands of people all around the world take part in clinical research studies every year.
  • Is taking part in a clinical research study voluntary?
    • Yes, taking part in any clinical research study is completely voluntary. If you decide to stop taking part at any time, it will not affect your future medical care in any way.
  • What is informed consent?
    • Before you can join any research study you need to agree to join by giving your ‘consent’. You must understand everything about the study before you give your consent. This is called being ‘informed’. You should not feel any pressure to give your consent. Feel free to discuss the study with family and friends before you make your decision.
  • Can my lupus be cured?
    • Unfortunately, lupus cannot currently be cured but a lot can be done to minimize its effects. Treatments are available that may help to control and improve symptoms, and there may be times when you are relatively symptom-free.
  • What is the study drug in the Meadow Clinical Research Study?
    • The study drug is an investigational medicine because it has not yet been approved for use in people with lupus. It will not be approved until clinical research studies such as the Meadow Clinical Research Study show that it is safe (causes no harm) and effective (works). We will also use a placebo. A placebo looks like the study drug, but it does not contain any active ingredients.
  • If I am given placebo, does this mean I receive no medicine for my lupus?
    • Everyone who joins the study will receive some treatment for their lupus while they are in the study.
  • How will I receive the study drug?
    • The study drug is in tablet form. You will need to take 5 tablets, once a day, with water.
  • How many visits would I have to make to the study site?
    • You would make about 18 clinic visits over the year you will be in the study.
  • Are there any risks involved in joining the study?
    • There are risks linked to taking an investigational medicine. You may experience side effects, or find that your symptoms do not improve or get worse. It is important that you tell your study doctor if you are worried about anything or if anything about your health changes.
  • What happens after the study ends?
    • You will no longer receive the study drug after your part in the study has ended. You will receive care from your usual doctor, as you did before the study.
  • What if the study is not right for me?
    • If the Meadow Clinical Research Study is not right for you, you will still receive treatment for your lupus. Please talk to your doctor about other treatment options.
  • What happens if I change my mind about taking part?
    • You are free to leave the study at any time without giving a reason. It will not affect your future medical care by your physician in any way.
  • What happens to my personal information?
    • Information about your personal health will be kept private. If you decide to contact us, your details will be transferred to the Meadow Clinical Research Study team. Someone from the team will contact you to better understand if the study is right for you. Your personal information will not be revealed to anyone outside of this clinical research study group without your consent unless required by law or regulations of the U.S. Food and Drug Administration (FDA) or other regulatory agencies.
Is the Meadow Clinical Research Study right for you?