INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA
- Conditions
- To evaluate the safety and efficacy of anti-CD20 therapy with respect to:-Clinical and laboratory adverse events, as measured every three months.-Survival and prevention of major organ failure (referred to as ¡¥event-free survival¡¦ which is considered the primary endpoint).-Impact on skin thickening, visceral involvement, functional status, and quality of life
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
1. Age between 18 and 70 years.
2. Established diagnosis of systemic sclerosis according to ARA-criteria (appendix).
Exclusion Criteria
1. Pregnancy or unwillingness to use adequate contraception during study.
2. Previous treatments with biological agents, cell depleting therapies including investigational
agents.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method