Frequently Asked Questions about Clinical Research:
What are clinical research studies?
All medications must be tested to determine if they are safe and effective. New investigational medications or devices are tested in clinical research studies. Clinical research studies are a way to help find potential future treatments. Clinical research studies are performed according to government rules to help protect the rights of study participants.
What is an investigational study medication?
An investigational study medication is a medication that is not approved for use or prescription by doctors for the condition or population being studied. Investigational study medications are tested during clinical research studies to see if they are safe and effective for a specific medical condition and/or group of people.
Why are clinical research studies done?
Clinical research studies are necessary to learn whether investigational study medications are effective and safe. The information gained from clinical research studies could help future patients who need this type of medical care. All investigational medications must go through clinical research studies before they will be approved by government agencies for use by the general population.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical research study before you decide to participate. It is also a continuing process throughout the study to provide information for participants. To help you decide whether or not to participate, the doctors and nurses involved in the clinical research study will explain the details of the study. The study team will then provide you with an informed consent form to read. The document includes details about the study, such as its purpose, duration and required procedures. Risks and potential benefits are also explained in the informed consent form. After you have received and read the information about the clinical research study, you will then decide whether or not to sign the document. No study-related procedures can take place before you have signed the informed consent form. The informed consent form is not a contract, and you may withdraw from the clinical research study at any time.
Is participation in a clinical research study voluntary?
Participation in any clinical research study is completely voluntary. If you decide to participate in a clinical research study, you are always free to withdraw at any time for any reason without any penalty or effect on your future medical care.
Frequently Asked Questions about the EMBODY program:
What is the purpose of the EMBODY program?
The EMBODY program is a clinical research study testing the safety and effectiveness of an investigational study medication in people with lupus. The EMBODY program is evaluating if the study medication can safely and effectively reduce the signs and symptoms of lupus and the amount of corticosteroids needed to control lupus symptoms.
What company is sponsoring the EMBODY program?
UCB, Inc. is the company sponsoring the EMBODY program.
What is the name of the investigational study medication?
The investigational study medication is called epratuzumab. Epratuzumab targets specific cells that are part of the immune system. This may prevent the immune system from attacking healthy tissue and help to reduce the level of inflammation in people with lupus.
Why should I take part in the EMBODY program?
During your participation, you may receive epratuzumab which could help your lupus symptoms. You may not experience any direct health benefits, but the information collected allows researchers to learn more about treating lupus, which could help people in the future.
What are the risks for participating in the EMBODY program?
You could experience side effects associated with the investigational study medication. There are also risks associated with some of the study procedures. Your lupus symptoms may not improve or may get worse during the study. The study staff will discuss all of the possible risks and potential benefits in detail with you before you decide to participate in this research program.
Who is conducting this clinical research program?
The EMBODY program is being conducted by trained and qualified licensed physicians and medical specialists worldwide.
Will I have to pay for anything if I participate in this clinical research program?
If you qualify for this clinical research program, all study-related medical care and the investigational study medication will be provided to you. The cost of regular medication will be billed to you or your insurance company.
Will I have to stop taking any of my current medications?
You may be allowed to continue taking your current lupus treatments such as prednisone, other corticosteroids, or immunosuppressants for the duration of your participation. The study doctor will discuss in further detail which medications are acceptable to take during participation in this clinical research program.
What is a placebo and is there a chance I could receive a placebo?
A placebo does not contain any active ingredients and may look similar to the investigational study medicine being tested. The use of a placebo is important in clinical research studies because it allows researchers to determine how well the active study medication may or may not be working.
There is the chance of receiving a placebo. All participants will be randomly assigned to one of three study treatment groups. Two of these groups will receive active study medication (at different dose levels). The third group will receive placebo. Neither you nor your study doctor will know to which group you are assigned.
How often would I have to go to the study site?
There are a total of 27 visits to the study site, including a screening visit to see if you are qualified to participate in the EMBODY program. Participation will last approximately one year.
Does my primary care physician have to give his or her permission for me to participate in this clinical research program?
No. However, you should let your doctor know that you plan to participate in this research program. With your permission, your doctor can contact the study doctor for more information at any time.
What should I tell my doctor/internist/primary care physician?
The study doctor will not take the place of your usual doctor. You should continue to see your regular doctor for any non-study medical care. For your safety, it is very important that you and/or your doctor contact the study site staff to report any changes in your health that you may experience while enrolled in this research program. You should also contact the study site staff if your doctor prescribes any new medications before you start taking them. Some medications are not allowed during the study because they may interfere or interact with the study medication.
Where can I find other helpful resources about lupus?
There are many resources available about lupus and ongoing lupus research. We have listed a few below. You can also ask your doctor for information on local support groups for lupus.