drugset / Trial / NCT01570764
Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease
Phase 3
Completed
40 enrolled
Assistance Publique - Hôpitaux de Paris
Hôpital Claude-Huriez · collabURC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
By including in this study patients with significant worsening of their lung volumes and / or their DLCO (carbon monoxide diffusing capacity) in the previous year, on the basis of an open retrospective study we recently conducted, we hope to demonstrate that a strategy combining prednisone and intravenous cyclophosphamide therapy is accompanied by an increase in the frequency stabilization / improvement of lung volumes and / or DLCO of patients at 12 months of 15% in the placebo and prednisone cyclophosphamide 50% in cyclophosphamide and prednisone.We also hope to demonstrate significant decrease in the number of patients excluded for failure in the CYC arm as compared to the placebo arm.
Timeline
- Start
- 2013-01-14
- Primary completion
- 2018-02-22
- Completion
- 2018-02-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 0.6 g | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 0.7 g | Intravenous |
| Background | Prednisone | Other / unclassified | 15 mg | — |