OBILUP. Induction therapy for lupus nephritis with no added oral corticosteroids : An open label randomised multicentre controlled trial comparing oral corticosteroids plus mycophenolate mofetil (MMF) versus Obinutuzumab and MMF.

lupus nephritis

Complete renal response (CR) at week 52 is defined as: - Urine PCR (protein to creatinine ratio) < 0.5 g/g - 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: o In the obinutuzumab arm: with no corticosteroids 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 an

Efficacy - Partial renal response (PR) will be defined as: o 50% improvement in spot uPCR o AND uPCR between 0.5 and 3 g/g o 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) - Complete renal response (independently of the treatment): see primary outcome - Proteinuria measurement: see primary outcome [1] - Extrarenal flare will be defined according to the SELENA-SLEDAI, Safety - Toxicity of corticosteroids will be measured with the Glucocorticoid Toxicity Index (GTI) (see Appendix D) - The number of serious adverse events will be measured per patient according to the CTCAE (version 5.0) toxicity grading system for the following adverse events combined: death (all causes), grade 3 or higher infections, hospitalization resulting either from the disease or from a complication due to the study treatment. - The number of serious infectious episodes will be measured, Non-adherence to treatment will be assessed with hydroxychloroquine blood levels and with questionnaires., Efficiency: incremental cost effectiveness ratio in cost per QALY.

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