None listed
Conditions
Interventions
Obinutuzumab will be administered by IV infusion as an absolute (flat) dose of 1000 mg
for four infusions on Days 1, 15, 168, and 182. Placebo infusion will be infused in the
same volume and on
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18−75 years • Ability to comply with the study protocol, in the investigator’s judgment • Diagnosis of SLE, according to current ACR criteria (at least four criteria must be present, one of which must be a positive ANA) • Diagnosis of ISN/RPS 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to or during screening. Patients may co-exhibit Class V disease in addition to either Class III or Class IV disease. • Proteinuria (urine protein to creatinine ratio) > 1.0, based on a 24-hour urine collection • For women who are not postmenopausal For men: agreement to remain abstinent or use a condom plus an additional contraceptive method
Exclusion criteria
Exclusion criteria: • Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE • Presence of rapidly progressive glomerulonephritis • Severe renal impairment • Greater than 50% of glomeruli with sclerosis on renal biopsy • Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization • Unstable disease with thrombocytopenia • Lack of peripheral venous access • Pregnancy or lactation • History of severe allergic or anaphylactic reactions to any component of the obinutuzumab infusion • Significant or uncontrolled medical disease in any organ system not related to SLE or LN, • Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn’s disease) that required oral or systemic steroid use in the 52 weeks prior to screening • Known HIV infection
Countries
Argentina, Brazil, Colombia, Costa Rica, France, Israel, Italy, Mexico, Panama, Spain, United States
Contacts
Public ContactLuisa Garcia
ROCHE FARMA (PERU) S.A.
Outcome results
None listed