drugset / Trial / NCT01446211
Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of Wegener Granulomatosis with or without ongoing steroids, and/or immunosuppressive therapy. Further, to evaluate the safety and quality of life of gusperimus treatment compared to standard treatment in patients with relapse of Wegener Granulomatosis receiving glucocorticoids.
Timeline
- Start
- 2011-11
- Primary completion
- 2012-11
- Completion
- 2015-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Gusperimus | Small molecule | — | — |
| Comparator | Methotrexate | Small molecule | — | — |