Empowered in the fight against LUPUS

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.