Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases

PHASE3CompletedINTERVENTIONAL
Enrollment

122

Participants

Timeline

Start Date

January 20, 2017

Primary Completion Date

July 24, 2019

Study Completion Date

February 17, 2020

Conditions
Lung Disease, Interstitial
Interventions
DRUG

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)

DRUG

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)

DRUG

Mycophenolate Mofetil

"Mycophenolate Mofetil 500mg film-coated tablets~1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months."

Trial Locations (5)

13015

AP-HM Hôpital NORD, Marseille

21079

Chu Dijon, Dijon

25030

Chu Besancon, Besançon

35033

Chu Rennes, Rennes

37044

CHRU Tours, Tours

All Listed Sponsors
lead

University Hospital, Tours

OTHER

NCT02990286 - Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases | Biotech Hunter | Biotech Hunter