196
Participants
Start Date
December 9, 2021
Primary Completion Date
December 31, 2031
Study Completion Date
December 31, 2031
Obinutuzumab administration
"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
"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
Prior to infusion of obinutuzumab, patients receiving obinutuzumab will receive premedication including 100 mg of methylprednisolone, paracetamol and dexchlorpheniramine.
RECRUITING
Internal medicine, Cochin hospital, APHP, Paris
Roche Pharma AG
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER