Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Sponsored by Human Genome Sciences Inc., a GSK Company
About this trial
Last updated 4 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 5 years ago
What is this trial about?
What are the Participation Requirements?
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.