The goal of the Tulip LN Study is to find out whether anifrolumab, an investigational drug, may help improve kidney function for those people with lupus nephritis or kidney disease associated with lupus. During the study period, participants will continue to take their currently prescribed LN medications.
SLE is the form of the disease most commonly known as lupus. When lupus affects the kidneys, it is called LN. In such instances, the tiny filters in the kidneys become damaged resulting in inflammation and reduced kidney function.
Not everyone will require medication for LN, but for those who do, it is important to preserve kidney function early.
The Tulip Program represents AstraZeneca’s commitment to developing a potential new investigational drug for lupus. It is only through clinical research that new investigational drugs can be developed, and participating in a clinical trial may allow you to play an even more active role in lupus research. It also helps our researchers, physicians, and participants better understand lupus.
A clinical research study, also referred to as a clinical trial, is a scientific study that evaluates the safety and effectiveness of an investigational study drug. A clinical research study may show that the investigational drug is better than, as good as, or no better than the standard treatment or inactive placebo. Qualified doctors, nurses and other medical professionals conduct the study itself.
It is only through the completion of clinical research studies that investigational medications can be evaluated, and if found safe and effective, approved for general use by the U.S. Food and Drug Administration (FDA).
For more information about clinical research studies in general, visit https://clinicaltrials.gov/ct2/about-studies.
An investigational study drug is a study drug that is not approved for medical use or prescription by the FDA or the condition being studied. Investigational drugs are tested during clinical research studies to see if they are potentially safe and effective for a specific medical condition and/or group of people.
Informed consent is the process of learning the key facts about a clinical research study before a participant decides to enroll. It is also a continuing process throughout the study to provide information to participants. To help you decide whether or not to participate, study doctors and nurses 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 clinical research 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 form. No study-related procedures can take place before signing an informed consent form. The informed consent form is not a contract, and you may withdraw from a clinical research study at any time.
Pharmaceutical companies conducting clinical research must follow strict rules set forth by the U.S. Food and Drug Administration (FDA). An independent professional group called an Institutional Review Board (IRB) is an ethics committee that approves, monitors and reviews all clinical research activity. The IRB must review and approve all materials being used during the study, including the study plan, or protocol, informed consent, and any materials used by participants, in order to ensure the highest degree of safety and well being for study participants.
The information you provide will not be shared with anyone who is not directly associated with this study without your permission (except as required by law).
The Tulip LN Study is a clinical research study testing the safety and effectiveness of an investigational study drug in people with lupus nephritis.
AstraZeneca is the sponsor of the clinical research study. The Tulip LN Study is being conducted by trained and qualified licensed physicians and medical specialists worldwide.
As a part of this study, participants may receive the investigational study drug, anifrolumab, or placebo. It is administered intravenously (IV) during your study visits. In the Tulip LN Study, anifrolumab is being evaluated in approximately 150 study participants with LN, in approximately 95 physician offices globally.
A placebo contains no active drug. A placebo is used in clinical research studies to determine if the active drug being evaluated is safer and more effective than no active drug. There is a one-in-three chance that you will receive a placebo in the Tulip LN Study. Neither you nor your study doctor will know if you are receiving active study drug or placebo. A placebo is not expected to have any effect on lupus.
Anifrolumab is an investigational drug that is believed to target a part of the immune system scientists think may be responsible for SLE and LN symptoms. Previous research study results suggested that the study drug (anifrolumab) may reduce lupus symptoms and the steroid dose needed by patients. However, no guarantee of effectiveness can be made.
Participation is voluntary. During your participation, you will receive study-related care from a team that may include doctors, nurses and other healthcare professionals at no charge. You may not experience any direct health benefits, but the information collected allows researchers to learn more about treating LN.
You could experience side effects associated with the investigational study drug. Your 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 study.
If you qualify for this clinical research program, all study-related medical care and the investigational study drug will be provided to you.
You may be allowed to continue taking your current lupus treatments such as prednisone, other corticosteroids, or immunosuppressant 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.
The study lasts approximately 15 months. If you pre-qualify and are referred to a study office, the study staff can provide you with more information.
Your participation in the study is entirely voluntary and you may withdraw at any time. If you decide to withdraw early from the study, you will be asked to notify the study staff before doing so; you may be asked to return to the study office at least once to complete a final visit.
While you do not need the permission of your primary care physician, you should inform your doctor if you decide to participate in this clinical research study. With your permission, your doctor can contact the study doctor for more information at any time.
The study doctor will not take the place of your primary care physician during the Tulip LN Study. You should continue to see your regular doctor(s) for any non-study-related medical care. For your safety, it is very important that you and/or your primary doctor contact the study staff to report any changes in your health that you may experience while enrolled in this clinical research study. You should also contact the study staff if your primary doctor prescribes any new medications before you start taking them. Some medications are not allowed during the study.
The Tulip Program is a series of clinical research studies evaluating an investigational drug for systemic lupus erythematosus (SLE) and lupus nephritis (LN).
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