drugset / Trial / NCT01275287
Targeting Complement Activation in Antineutrophil Cytoplasmic Autoantibodies (ANCA)-Vasculitis - Eculizumab
Phase 2
Withdrawn
University of North Carolina, Chapel Hill
Alexion Pharmaceuticals, Inc. · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this research study is to see if Eculizumab (Soliris®) can safely be used in addition to conventional therapy in patients with active ANCA (Antineutrophil Cytoplasmic Autoantibodies ) vasculitis and lead to a more rapid decrease in disease activity. ANCA vasculitis is an inflammation of the small vessels whereby ANCA antibodies inappropriately activate one's own white blood cells (neutrophils) and cause damage to the small blood vessels.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eculizumab | Monoclonal antibody | 900 mg | Intravenous |
| Comparator | Azathioprine | Small molecule | 1.5 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 2 mg/kg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 1000 mg/m2 | Intravenous |
| Comparator | Methylprednisolone | Other / unclassified | 7 mg/kg | Intravenous |
| Comparator | Prednisone | Other / unclassified | 1 mg/kg | Oral |
| Comparator | Rituximab | Monoclonal antibody | — | — |