Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 33
Healthy volunteers: no

Brief summary:
This is a Phase III, randomized, double blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of ocrelizumab compared to placebo when combined with a single stable background immunosuppressive medication and a corticosteroid regimen in patients with moderately to severely active systemic lupus erythematosus, who do not have moderate to severe glomerulonephritis.

Detailed description:

Arms:
arm 1: Ocrelizumab was administered i.v. at a dose on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks arm 2: Ocrelizumab was administered at a dose 400 mg i.v. on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks arm 3: Placebo infusions were administered on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks

Interventions: intervention 1: Prednisone intervention 2: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate) intervention 3: Methylprednisolone intervention 4: Ocrelizumab intervention 5: Placebo
Intervention descriptions: intervention 1: Oral repeating dose intervention 2: Oral repeating dose intervention 3: Intravenous repeating dose intervention 4: Intravenous repeating dose intervention 5: Intravenous repeating dose

Protocol document: