Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Human Genome Sciences Inc., a GSK Company
With
GlaxoSmithKline
Study participants receive standard therapy (induction and maintenance) for lupus nephritis in addition to receiving either placebo (no active medicine) or belimumab. Induction therapy starts before the first dose of study drug (belimumab or placebo). Maintenance therapy begins after completion of induction therapy and continues for the remainder of the study. Participants receive study drug throughout the entire study, during both induction and maintenance periods. The controlled period of the study is 104 weeks. The random assignment in this study is "1 to 1" which means you have an equal chance of receiving treatment with belimumab or placebo. Participants who successfully complete the 104-week study may enter into a 6-month open-label extension. All participants in the open-label extension receive belimumab.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
Biopsy confirmed active lupus nephritis.
Clinically active lupus renal disease at screening requiring /receiving induction therapy with Standard of Care medications.
Autoantibody-positive.
You may not be if
Pregnant or nursing.
On dialysis within the past year.
Treatment with belimumab within the past year .
Receipt of induction therapy with cyclophosphamide within 3 months prior to induction therapy for the study.
Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
Severe active central nervous system (CNS) lupus.
Required management of acute or chronic infections within the past 60 days.
Current drug or alcohol abuse or dependence.
Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
History of severe allergic reaction to contrast agents or biological medicines.
Clareo Health | Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis