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

Summary

The purpose of the study is to evaluate the efficacy on lung function 6 months after one course of rituximab (2 infusions) and mycophénolate mofétil (MMF) treatment compared to one course of placebo and 6 months of MMF treatment in a broad range of patients with Interstitial Lung Diseases (ILD) non-responders to a first line immunosuppressive treatment.

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.

Sponsors & Collaborators

• University Hospital, Tours

  lead OTHER

Principal Investigators

• TRACLET Julie · HC LYON

• NUNES Hilario · AP-HP - Hôpital Avicenne

• CRESTANI Bruno · AP-HP - Hôpital Bichat

• ISRAEL BIET Dominique · AP-HP HEGP

• NACCACHE Jean-Marc · AP-HP - Hôpital Tenon

• WEMEAU Lidwine · CHRU LILLE

• JOUNEAU Stéphane · CHU Rennes

• PREVOT Grégoire · University Hospital, Toulouse

• REYNAUD-GAUBERT Martine · AP-HM Hôpital Nord

• HIRSCHI SANTELMO Sandrine · CHRU Strasbourg

• GONDOUIN Anne · Centre Hospitalier Universitaire de Besancon

• COURT-FORTUNE Isabelle · CHU ST-ETIENNE

• BONNIAUD Philippe · CHU DIJON

• QUETANT Sébastien · University Hospital, Grenoble

• GOMEZ Emmanuel · CHU NANCY

• BLANC François-Xavier · Nantes University Hospital

• MARQUETTE Charles-Hugo · CHU NICE

• MARCHAND-ADAM Sylvain · CHRU TOURS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-20

Primary Completion

2019-07-24

Completion

2020-02-17

Countries

• France

Study Locations