IRB Number:

07-007326

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is designed to evaluate the ability of ocrelizumab, a humanized anti-CD20 monoclonal antibody, to induce and maintain a complete or partial renal response in patients with proliferative lupus nephritis. Because lupus nephritis can result in rapid and irreversible loss of renal function, and B cell depletion has yet to be demonstrated to be clinically effective within a double blind study, ocrelizumab will be added onto standard-of-care treatment for lupus nephritis.

There is currently no universally accepted standard of care for the treatment of lupus nephritis, but therapy most commonly includes high dose corticosteroids and cytotoxic drugs such as cyclophosphamide. More recently, mycophenolate mofetil has been evaluated for the treatment of proliferative lupus nephritis. Currently used treatment regimens are associated with significant toxicity (particularly when used over extended periods of time), and relapses as well as progression to chronic renal failure remain common. B cell depletion has been associated with improved outcomes in uncontrolled case series and individual case reports and appears to be well tolerated when given together with the standard of care regimens for the treatment of lupus nephritis which will be used in this study. We will enroll 10 patients.

Who is Eligible to Participate in the Study?

Age 18 and older

Minimum Age:

18

Maximum Age:

70

What is Involved With this Study?

Double-Blind Treatment Period: Patients will be randomized and will receive a combination of IV and oral corticosteroids as part of their initial therapy for lupus nephritis as well as standard of care immunosuppressive therapy for the treatment of your lupus nephritis. In addition, you will be randomly assigned (like flipping a coin) to be treated with either ocrelizumab or placebo (an inactive substance which looks like the real medicine) in addition to your regular therapy that you are taking for your disease. There is a 2 out of 3 chance that you will receive ocrelizumab. The idea is to see if adding ocrelizumab improves the treatment response in lupus nephritis. The study drug will be administered by intravenous (IV) infusion on Days 1 and 15, and then every 16 weeks thereafter. In between the infusion visits, you will return every 4 weeks for non-infusion visits to monitor your disease activity and general health and have blood and urine tests performed. At the Week 48 visit, your doctor will assess your clinical response to the blinded treatment. Based on your clinical response, you may either enter the study extension treatment period or enter the open-label period.

Study Extension Period: At the Week 48 visit, you will enter into this period if your doctor determines that you are responding adequately to the blinded treatment. You will continue to receive the blinded treatment every 16 weeks up to at least Week 96. In between the infusion visits, you will return every 8 weeks for non-infusion visits to monitor your disease activity and general health and have blood and urine tests performed.

Open-Label Period: If your lupus nephritis is not improving adequately at the Week 48 visit and if you agree to continue, your doctor can decide to enter you in the open-label period of the study where you will receive Ocrelizumab (active drug). In between the infusion visits, you will return every 8 weeks for non-infusion visits to monitor your disease activity and general health and have blood and urine tests performed.

Safety Follow-Up Period: Your general health will be monitored for safety throughout the trial. If you withdraw from either the treatment periods or from the open-label period for any reason, your safety will continue to be monitored for at least 48 weeks following the last infusion of study drug, and you will be asked to return every 12 weeks to have blood tests performed.

How long will the Study run?

All patients will be followed for a minimum of 96 weeks. You will be followed in the safety follow-up period for at least 48 weeks after the last drug infusion.

Who can I Contact for Additional Information on this Trial?

Lori Riess
Phone: 507-266-1047
Email: riess.lori@mayo.edu

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 11/24/2008