Conditions: Lupus Nephritis Systemic Lupus Erythematosus
Keywords: SLE Lupus BELONG
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 381
Healthy volunteers: no

Brief summary:
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.

Detailed description:

Arms:
arm 1: Participants received Ocrelizumab 400 mg i.v. infusion on Days 1 and 15, followed by 400 mg i.v. at Week 16 and then every 16 weeks plus SOC regimen. arm 2: Participants received Ocrelizumab 1000 mg i.v. infusion on Days 1 and 15, followed by 1000 mg i.v. at Week 16 and then every 16 weeks plus SOC regimen. arm 3: Participants received placebo i.v. infusion on Days 1 and 15, followed by placebo infusion at Week 16 and then every 16 weeks plus SOC regimen.

Interventions: intervention 1: Corticosteroids intervention 2: Cyclophosphamide intervention 3: Mycophenolate Mofetil intervention 4: Ocrelizumab intervention 5: Placebo intervention 6: Azathioprine
Intervention descriptions: intervention 1: Intravenous and oral repeating dose intervention 2: Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine. intervention 3: Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day. intervention 4: Ocrelizumab was administed at a dose and as per schedule in arm description intervention 5: Placebo was administered as per schedule in arm description intervention 6: Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.

Protocol document: