Microscopic Polyangiitis Clinical Trial
Official title:
Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial
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.
ANCA (anti-neutrophil cytoplasmic antibody)-associated vasculitis is characterised by small vessel vasculitis and presence of autoantibodies, ANCA. It can be a life-threatening disease with renal/respiratory failure. Current standard therapy in induction remission for ANCA-associated vasculitis is combination of high-dose glucocorticoid and IV-cyclophosphamide. This regimen is effective (remission rate; 80-90%), but often cause various glucocorticoid-related side effects. Especially, infection is related to death. Thus a new regimen reducing glucocorticoid dose is required. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01729624 -
PRO Development for ANCA Associated Vasculitis
|
N/A | |
Terminated |
NCT02474888 -
Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
|
||
Completed |
NCT02190916 -
Vasculitis Illness Perception (VIP) Study
|
N/A | |
Recruiting |
NCT01241305 -
One-Time DNA Study for Vasculitis
|
||
Completed |
NCT00748644 -
Efficacy Study of Two Treatments in the Remission of Vasculitis
|
Phase 3 | |
Recruiting |
NCT02967068 -
VCRC Tissue Repository
|
||
Completed |
NCT01731561 -
Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis
|
Phase 3 | |
Not yet recruiting |
NCT06350110 -
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
|
Phase 1/Phase 2 | |
Completed |
NCT02190942 -
VCRC Patient Contact Registry Patient-Reported Data Validation Study
|
||
Not yet recruiting |
NCT02126098 -
Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis
|
N/A | |
Terminated |
NCT01586858 -
Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study
|
N/A | |
Completed |
NCT00307593 -
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
|
N/A | |
Completed |
NCT02190929 -
Educational Needs of Patients With Systemic Vasculitis
|
N/A | |
Terminated |
NCT01408836 -
Plasma Exchange for Renal Vasculitis
|
Phase 2/Phase 3 | |
Terminated |
NCT05376319 -
PR3-AAV Resilient Remission or PRRR
|
Phase 2 | |
Completed |
NCT02476292 -
Impact of Vasculitis on Employment and Income
|
N/A | |
Completed |
NCT02169219 -
Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
|
Phase 4 | |
Completed |
NCT01613599 -
An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
|
||
Active, not recruiting |
NCT05716334 -
Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator
|
||
Completed |
NCT00307671 -
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years
|
Phase 4 |