posteritystudy.texasarthritiscenter.co
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Submission: On July 10 via automatic, source certstream-suspicious — Scanned from DE
Submission: On July 10 via automatic, source certstream-suspicious — Scanned from DE
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Text Content
JOIN A CLINICAL RESEARCH STUDY FOR LUPUS NEPHRITIS Let’s Tackle Lupus Together LEARN MORE Participants must be between 12 and 18 years old Individuals must be diagnosed with Lupus Nephritis The goal is to find potential new treatments WHAT IS THE POSTERITY STUDY? Lupus nephritis (LN) is caused by systemic lupus erythematosus (SLE) and occurs more frequently in younger patients than adults. It’s a serious condition, and yet limited treatment options exist. Developing a new, effective treatment option for LN is important. This clinical study will track how safe and effective a study drug is in combination with the current standard treatment for LN. The information obtained may help children and adolescents below age 18 with LN in the future. Clinical studies are common Overseen by medical professionals This study lasts for two years WHAT TO EXPECT WITH THIS STUDY 4-Week Screening Period This screening period allows us to carry out some tests to ensure individuals are eligible to participate in this study. Double-Blind Treatment Period Participants are randomly assigned to receive one of the following: * Five infusions of the study drug (2 in 3 chance) * Five infusions of a placebo (1 in 3 chance) Treatment Extension Period At the end of the double-blind treatment, depending on the review, you’ll either: * Continue to receive three additional infusions of what you received before * Knowingly receive the study drug for an additional five infusions Safety Follow-Up Period We’ll continue to monitor your health and condition once every six months. These visits will last as long as necessary but at least 12 months after your last study treatment infusion. You may continue receiving the standard LN treatment during the safety follow-up period at your study doctor’s discretion. What Is a Placebo? A placebo looks just like the study drug and is given the same way. However, it contains no active medicine and is often called a dummy drug. They're used so researchers can better evaluate the overall effectiveness of the study drug. How Is the Study Drug Administered? The study drug and the placebo will be given as an intravenous (IV) infusion. This will take between four and five hours to administer each time. A blinded treatment means that participants won’t know if they’re receiving the study drug or the placebo. LEARN MORE HOW WILL MY HEALTH BE CHECKED? During the study, you’ll have 11 visits over an approximately 18-month period so the study team can check your general health and see how you’re responding to your study treatment. General health check-ins may include: Physical exams Blood tests Urine tests TEXAS ARTHRITIS CENTER CLINICAL HEALTH STUDIES Providers at the Texas Arthritis Center participate in clinical research studies and have served as principal investigators and sub-investigators in several studies. In these trials, researchers evaluate investigational medications under carefully controlled conditions. The FDA only approves medications if they are found to be safe and effective during the clinical research process. It takes a team of healthcare professionals to conduct a research study. Besides the main physician who oversees the study, the research team may include other doctors, nurses, study coordinators, and other healthcare professionals. THIS STUDY IS OF NO COST TO PARTICIPANTS Contact us to see if you qualify LEARN MORE or call (915) 317-1660 © 2023 TEXAS ARTHRITIS CENTER. ALL RIGHTS RESERVED. PRIVACY POLICY Thank You!