Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

PHASE3RecruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

December 9, 2021

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2031

Conditions
Lupus NephritisSystemic Lupus Erythematosus (SLE)
Interventions
DRUG

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."

DRUG

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."

DRUG

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.

Trial Locations (1)

75014

RECRUITING

Internal medicine, Cochin hospital, APHP, Paris

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

lead

Assistance Publique - Hôpitaux de Paris

OTHER