Autologous Stem cell Transplantation International Scleroderma (ASTIS) trial
Completed
- Conditions
- Systemic sclerosisMusculoskeletal Diseases
- Registration Number
- ISRCTN54371254
- Lead Sponsor
- European Group for Bone Marrow Transplantation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 156
Inclusion Criteria
Patients with diffuse systemic sclerosis, aged 16 to 65 years, and:
1. Disease duration four years or less, plus evidence of heart, lung or kidney involvement, plus skin score of 15 or more, or
2. Disease duration two years or less, plus evidence of an acute phase reaction in blood, plus skin score 20 or more
Exclusion Criteria
Patients with concomitant severe disease, extensive pretreatment according to predefined criteria with cyclophosphamide are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure(s) as of 29/05/2012<br>The primary endpoint is event-free survival defined as the time in days from the day of randomisation until the occurrence of death or the development of persistent major organ failure (heart, lung, kidney).<br><br>Previous primary outcome measure(s)<br>The primary endpoint is event-free survival defined as the time in days from the day of randomisation until the occurrence of death or the development of persistent major organ failure (heart, lung, kidney) during the study period of two years.
- Secondary Outcome Measures
Name Time Method Key secondary outcomes include: <br>1. Treatment related mortality<br>2. Treatment toxicity <br>3. Progression-free survival