Mouthon 2016.
| Trial name or title | Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease (SCLEROCYC) |
| Methods | Randomised placebo‐controlled trial |
| Participants | Adults > 18 years with systemic sclerosis fulfilling ACR (American College of Rheumatology) diagnostics criteria with worsening ILD (interstitial lung disease) identified on a high‐resolution chest CT scan and by worsening of forced vital capacity (FVC) and/or total lung capacity (TLC) ≥ 10% and/or worsening of DLCO ≥ 15% as compared with values obtained within the 3 to 18 months preceding inclusion (for DLCO, in the absence of pulmonary arterial hypertension upon echocardiography) |
| Interventions | Prednisone 15 mg/d + monthly pulse cyclophosphamide 700 mg/m² diminished to 600 mg/m² in patients over 65 years or with creatinine clearance < 30 mL/min for 12 months vs Prednisone 15 mg/d + monthly pulse of placebo |
| Outcomes | Primary outcome measures
• Forced vital capacity at 12 months Secondary outcome measures • Mortality at 12 months • Progression‐free survival at 12 months • Progression‐free survival • Carbon monoxide diffusing capacity (DLCO) at 12 months • Treatment failure at 12 months • Failure of cyclophosphamide or placebo • Walk test distance at 12 months • Six‐minute walk test distance, O2 desaturation, and gradient between maximal and minimal SaO2 during the test • Dyspnoea at 12 months • NYHA (New York Heart Association Classification), BDI (Beck Depression Inventory), and Borg index • Health Assessment Questionnaire at 12 months • Quality of life at 12 months • Saint Georges; SF‐36 • Chest CT (computed tomography) scan at 12 months • CT scan abnormalities |
| Starting date | January 2013 |
| Contact information | Principal Investigator: Luc Mouthon, Cochin Hospital |
| Notes |
ACR: American College of Rheumatology.
BDI: Beck Depression Inventory.
CT: computed tomography.
DLCO: diffusing capacity of the lung for carbon monoxide.
FVC: forced vital capacity.
GCP: good clinical practice.
ILD: interstitial lung disease.
NHS: National Health Service.
NYHA: New York Heart Association.
O2: oxygen.
SaO2: oxygen saturation.
SF‐36: Short Form‐36.
TLC: total lung capacity.