Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GAZYVARO® administration
Obinutuzumab administration · 1 trial · 2 indications
CR at week 52 without receiving corticosteroids above a prespecified dose. CR at week 52 is defined as: * Urine PCR (protein to creatinine ratio) \< 0.5 g/g in a spot urine AND: * eGFR (estimated glomerular filtration rate using CKD-epi) ≥ 60 ml/min, or if \< 60 ml/min at screening, no decline \>20% compared to screening/randomisation (whichever worse) * AND: * In the obinutuzumab arm: with no steroids or without receiving oral corticosteroids \> 10 mg/day within the first 6 month, and then, without receiving oral corticosteroids \> 7.5 mg/day between 6 and 9 months and \> 5 mg/day between 9 and 12 months for SLE indication (according to the French PNDS for SLE after 6 months). * In the steroid arm: without receiving corticosteroids above the prescribed taper (according to the French PNDS for SLE, see Appendix A), including without receiving oral corticosteroids \> 7.5 mg/day between 6 and 9 months and \> 5 mg/day between 9 and 12 months for SLE indication (according to the French
Proteinuria measurement: the proteinuria/creatinuria ratio will be assessed on a 24-hour urine collection.
| Arm | Type | Description |
|---|---|---|
| Obinutuzumab arm | EXPERIMENTAL | Obinutuzumab administration plus oral mycophenolate mofetil (MMF) |
| Corticosteroids arm | ACTIVE_COMPARATOR | Oral corticosteroids plus MMF |
| Name | Type | Description |
|---|---|---|
| Obinutuzumab administration | DRUG | Obinutuzumab administration by intravenous infusion (IV), IV of methylprednisolone, oral mycophenolate mofetil, no prednisone (or if required for extrarenal manifestation(s): less than 10mg/day at any time, less than 7.5mg/day after 6 months and less than 5mg/day after 9 months). Hydroxychloroquine will be strongly recommended for all the patients. |
| Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil | DRUG | IV of methylprednisolone, oral prednisone (according to the PNDS), and oral mycophenolate mofetil. Hydroxychloroquine will be strongly recommended for all the patients. |
| Administration of methylprednisolone, paracetamol and dexchlorpheniramine | DRUG | Prior to infusion of obinutuzumab, patients receiving obinutuzumab will receive premedication including 100 mg of methylprednisolone, paracetamol and dexchlorpheniramine. |
Inclusion Criteria: * Children aged 14-17 years old and adults; * Active lupus nephritis, as defined by kidney biopsy within the preceding 8 weeks, assessed by the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification: class III or IV (A or A/C) ± V with active lesion...
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