Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 14, 2013

Primary Completion Date

February 22, 2018

Study Completion Date

February 22, 2018

Conditions
Systemic SclerosisSclerodermaInterstitial Lung DiseaseLung Fibrosis
Interventions
DRUG

Cyclophosphamide

Prednisone 15 mg/d + monthly pulse cyclophosphamide 700 mg/m ² diminished to 600 mg/m ² in patients over 65 years or having a creatinine clearance lower than 30 ml/min for 12 months.

DRUG

Placebo

Prednisone 15 mg/d + monthly pulse of placebo of cyclophosphamide. The posology and the methods of administration of the placebo of cyclophosphamide (NaCl) will be the same as those used for cyclophosphamide

Trial Locations (1)

75014

Cochin Hospital, Paris

All Listed Sponsors
collaborator

Hôpital Claude-Huriez

OTHER

collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT01570764 - Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease | Biotech Hunter | Biotech Hunter