Low-dose Glucocorticoid Vasculitis Induction Study

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Vasculitis
Wegener Granulomatosis

Clinical Trial Details

NCT number	NCT02198248
Study type	Interventional
Source	Chiba University
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	October 2014
Completion date	June 2021

View Details

See also
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
Not yet recruiting	`NCT02126098` - Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis	N/A
Completed	`NCT02190942` - VCRC Patient Contact Registry Patient-Reported Data Validation Study
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Low-dose Glucocorticoid Vasculitis Induction Study — LoVAS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms