Description
The purpose of this study is to find out if the study drug, Obinutuzumab, is effective in achieving a complete renal response for adolescents with active class III or IV lupus nephritis. Researchers will also be testing how the body processes a drug by measuring how quickly the drug is absorbed by the body, how quickly it is broken down by the body, and how long it remains in the body (pharmacokinetics). Subjects will be asked to come into the Rheumatology clinic for blood, hepatitis and pregnancy testing, physical exam, an electrocardiogram (ECG), questionnaire completion, chest x-ray, MMF/oral corticosteroid use, medical record review, optional genetic testing, and administration of study drug. Obinutuzumab is administered as an infusion 5 times over the course of the study.
What to expect
The study will consist of four periods: a screening period of up to 28 days in length, a 76-week treatment period, a 76-week treatment extension period, and a minimum 12-month safety follow-up (SFU) period that begins at the time of study treatment completion or discontinuation. All of these periods, except for the treatment extension period (optional at investigator discretion), are required for participation in the study.
