Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to see how well an investigational study drug works and what effects (good and bad) it has on the quality of life in children with systemic lupus erythematosus (SLE, or lupus for short) who are taking other lupus medicine. We will also test the safety of this drug.
The study drug being tested has been approved in the United States, Canada and Europe for the treatment of adults with rheumatoid active SLE who are receiving other lupus medicines. For this study in children and adolescents, the medication is considered investigational because the U.S. Food and Drug Administration (FDA) have not approved it for use in children.
What will happen in the study?
This research study will compare the investigational study drug and a placebo (which contains no active medicine) given in addition to the current medicines that your child is receiving to manage their lupus.
Your child will be "randomized” into 1 of 2 study groups. This means that your child will be put into the study group completely by chance, like flipping a coin. One group will receive the study drug and another group will receive the placebo. Neither you nor the study doctor will know if your child is receiving the study drug or placebo.
Your child will receive either the study drug or placebo by intravenous infusion (the drug will be administered through a solution into the vein) once a week for 52 weeks. After 52 weeks, participants can enter the second part of the study where they can receive the active study drug by infusion every month for at least 5 years, and possibly up to 10 years.
A detailed list of procedures will be provided to anyone interested in knowing more about this study.