Learn about and take part in a new study enrolling eligible participants with systemic lupus erythematosus (SLE) while staying on your current treatment for SLE.
The TOPAZ studies are evaluating the safety and potential efficacy of an investigational study medication in people with active SLE who are still taking their current SLE non-biologic therapy. If you still experience symptoms even with your medication, a TOPAZ Study may be an option for you.
The TOPAZ Studies will last about a year and a half and include around 22 visits to the study site.
You will be randomly assigned – that means selected by chance – to receive either the study drug or a placebo (an inactive substance that looks like the drug being tested).
*The study team will discuss with you any additional criteria to participate.
(If you don’t qualify initially, you may choose to be contacted at a later time to see if you may qualify in the future.)
Before you join a TOPAZ Study, the study team will tell you about the study as part of the informed consent process. It is completely up to you whether you join and you are free to leave at any time. During the study, you will continue to take your prescribed SLE treatment. Additionally, you will receive either the study medication or a placebo (which looks like the study medication but contains no active medication). There is a 2 in 3 chance that you will receive the study medication and a 1 in 3 chance of receiving a placebo. Your treatment group will be assigned at random (by chance), so neither you nor the study team will know which one you are receiving. However, in case of an emergency, the study doctor can quickly find out.
The study medication or the placebo will be administered via injections under the skin (subcutaneous) every 4 weeks at the study site.
Your health will be monitored during regular study visits that occur every 4 weeks throughout the treatment period. All assessments will be completed before you receive the study medication or the placebo at each visit.
The idea of taking part in a clinical trial might be scary. You should know that participant safety is our number one priority during every stage of the study process. All research studies are carefully supervised, monitored, and documented. Every clinical research study is reviewed and approved by a special group of people called an Institutional Review Board (IRB) or an Ethics Committee (EC), which is made up of scientists, nonscientist professionals, and members of the public. They make sure that participants’ rights are protected, and they seek to avoid exposure to unnecessary risks. IRBs and ECs will only approve studies that they think could help answer important medical questions.
While the study is ongoing, a team of study doctors and nurses at the study site will closely monitor your health. If you have questions or concerns at any point throughout the study, a study staff member is available. The study staff can also tell you about their COVID-19 safety protocols.
Your participation is voluntary, and you are free to withdraw at any time for any reason. Although others can help make up your mind, the final decision is yours to make. Your privacy will be maintained throughout the study.
This section will help answer some important questions you may have.
To support the development of this potential new treatment for SLE, the study medication was evaluated in patients with SLE in previous research studies. These earlier research studies looked at the safety of the study medication in people with SLE and whether it helped control their symptoms as compared to a placebo. Based on the positive results from those studies, 2 new studies will investigate if the study medication works better than a placebo to control symptoms of SLE when used in addition to a standard SLE treatment. The studies will also help determine if the study medication is generally safe in a larger number of people with SLE.
The TOPAZ Studies are being conducted in over 25 countries, with about 180 clinical trial locations recruiting 1080 patients with active SLE who are staying on their current treatment for SLE.
Biogen is conducting the TOPAZ Studies. Biogen is a global biotechnology company located in Cambridge, Massachusetts.
Deciding to participate in a research study is an important and personal decision. Before you agree to participate, the study team will review all aspects of the research study with you. You will be given a document called an Informed Consent Form that provides, in writing, the research study's purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and are encouraged to speak with your own physician to decide if taking part is right for you.
No, all study-related medical care and the study medication will be provided at no cost. You may be paid back for some of your transportation, childcare, and other costs related to the study. The study staff can give you more information about this.
You don’t need health insurance to join a clinical trial. And the medication being studied and the study-related procedures are free. However, you or your insurance may be responsible for medical expenses that are part of your usual healthcare. Talk with your study team to find out exactly what is covered.
Yes. There is a 1 in 3 chance of receiving a placebo during this study. A placebo is a substance that looks like the study medication but contains no active medication. A placebo helps to differentiate any changes seen during the study and determine whether they are due to the study medication alone and not another reason.
There is also a 2 in 3 chance that you will receive the study medication. Your treatment group will be assigned at random (by chance), so neither you nor the study team will know which one you are receiving. However, in case of an emergency, the study doctor can quickly find out.
Yes, the information you provide will not be shared with anyone who is not directly associated with this research study without your permission, except as required by law or as set forth in the Informed Consent Form, the document you would sign before participating in the study. Immigration status is generally not collected in clinical trials and will not be collected in any Biogen clinical trial.
No, your doctor does not have to give you permission to participate. However, feel free to talk to your doctor about participating in the study. With your permission, the study doctor will keep your regular doctor updated about your condition during the study.
Yes, your participation in any research study is completely voluntary. If you decide to participate, you are free to withdraw at any time, for any reason, without any penalty or effect on your future medical care. You should talk to your study doctor about leaving the study so that they can schedule a final evaluation.
A research study, also known as a clinical trial, is a scientific study that evaluates the safety and effectiveness of a study medication. Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.
It is only through the completion of research studies that study medications can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries will provide this approval after a thorough review, like the US Food and Drug Administration (FDA).
In order to ensure that a research study is ethical, and that patients’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review study protocols.
Only patients who meet all required eligibility criteria for a research study may take part. The study team at the study doctor’s office will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the research study. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational study medication is a medication that has not been approved by regulatory or health authorities (eg, the US Food and Drug Administration [FDA], European Medicines Agency [EMA], or appropriate regulatory authorities in each country) for prescription use. Before a trial ever allows people to join, it must go through approvals and reviews by organizations and agencies like the US Food and Drug Administration (FDA) as well as scientists, doctors, and community members to make sure it is generally safe and ethical for people to take part.