Low-dose Glucocorticoid Vasculitis Induction Study
Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Previous reports suggested conventional immunosuppressants such as cyclophosphamide could not
reduce glucocorticoid dose in remission induction in ANCA-associated vasculitis because of
lower remission rate and higher relapse rate. However those reports didn't include rituximab.
B cell depletion therapy by rituximab is a new strategy for remission induction in
ANCA-associated vasculitis. The RAVE and RITUXVAS trial (NEJM 2010, both) showed high-dose
glucocorticoid plus rituximab had roughly the same efficacy and safety as high-dose
glucocorticoid plus IV-cyclophosphamide. In addition, recent retrospective observational
studies reported low-dose glucocorticoid plus rituximab led to re-induction in severe
relapsing ANCA-associated vasculitis.
Thus, the investigators aim to investigate whether rituximab can reduce glucocorticoid dose
in induction remission in ANCA-associated vasculitis (to show non-inferiority for efficacy
between low-dose and high-dose glucocorticoid plus rituximab). Participants will be
randomised to the "low-dose glucocorticoid plus rituximab" or the high-dose glucocorticoid
plus rituximab" groups. Primary endpoint is proportion of remission at 6 months, then data
regarding relapse and long-term safety will be collected until 24 months.
The study has been designed by the principal and coordinating investigators. It will include
140 participants from 18 hospitals in Japan. It is funded by Chiba University Hospital and
Chiba East Hospital.
Phase:
Phase 4
Details
Lead Sponsor:
Chiba University
Collaborator:
National Hospital Organization Chiba East Hospital