ASTIS trial selection criteria
| Inclusion: | Age 16–60 |
| Diffuse skin SSc3-150 plus at least one vital organ affected (defined) | |
| Duration of skin disease ( excluding sclerodactyly) <4 years | |
| Initial skin score ( modified Rodnan max 51) >14 | |
| Exclusion: | Left ventricular ejection fraction <45% normal |
| Uncontrolled cardiac arrhythmias | |
| Uncontrolled hypertension | |
| Pulmonary diffusion capacity <40% predicted | |
| Respiratory failure—Pao 2 <8 kPa (60 mm Hg) | |
| Mean pulmonary artery pressure >50 mm Hg | |
| Renal failure—creatinine clearance <40 ml/min | |
| >5 g cumulative dose Cy3-150 or >3 months Cy 2 mg/kg/day |
Further details available at: www.astistrial.com
↵3-150 SSc = systemic sclerosis; Cy = cyclophosphamide.