122
Participants
Start Date
January 20, 2017
Primary Completion Date
July 24, 2019
Study Completion Date
February 17, 2020
Rituximab
Rituximab 500mg concentrate for solution for infusion. One course of IV rituximab consisting of a first infusion of 1000 mg (500 ml solution) rituximab (day 1 infusion), and a second infusion of 1000 mg (500 ml solution) rituximab two weeks later (day 15 infusion)
Placebo of Rituximab
500 ml of saline (0.9% sodium chloride) for infusion One course of intravenous placebo of rituximab consisting of a first infusion of 500 ml of saline (0.9% sodium chloride) infusion (day 1 infusion), and a second infusion of 500 ml of saline infusion two weeks later (day 15 infusion)
Mycophenolate Mofetil
"Mycophenolate Mofetil 500mg film-coated tablets~1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months."
AP-HM Hôpital NORD, Marseille
Chu Dijon, Dijon
Chu Besancon, Besançon
Chu Rennes, Rennes
CHRU Tours, Tours
University Hospital, Tours
OTHER