Low-dose Glucocorticoid Vasculitis Induction Study (LoVAS)
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis, Wegener Granulomatosis
About this trial
This is an interventional treatment trial for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent by a patient or a surrogate decision maker
- Age=>20 years
- New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis or renal limited ANCA-associated vasculitis) consistent with the 2012 Chapel Hill consensus definitions
- Positive test by ELISA for proteinase 3-ANCA or myeloperoxidase-ANCA
Exclusion Criteria:
- Prior treatment for ANCA-associated vasculitis before trial entry
- ANCA-associated vasculitis related glomerulonephritis (eGFR<15ml/min) or alveolar hemorrhage (oxygen inhalation >2L/min)
- Presence of another multisystem autoimmune disease
- Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection
- Desire to bear children, pregnancy or lactating
- History of malignancy within the past 5 years or any evidence of persistent malignancy
- Ongoing or recent (last 1 year) evidence of active tuberculosis
- Severe allergy or anaphylaxis to monoclonal antibody therapy
- Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg
- Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months
- Other conditions, in the investigator's opinion, inappropriate for the trial entry
Sites / Locations
- Asahi General Hospital
- Kameda Medical Centre
- Matsudo City Hospital
- Japanese Red Cross Narita Hospital
- Shimoshizu Hospital
- Hokkaido University
- Yokohama Rosai Hospital
- Saitama Medical Center
- Dokkyo Medical University
- Teikyo University
- Keio University Hospital
- Akita University
- Chiba University Hospital
- Chiba Aoba Municipal Hospital
- Chiba East Hospital
- Fukushima Medical University
- Niigata University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Low-dose glucocorticoid
High-dose glucocorticoid
Prednisolone will be commenced with dose of 0.5mg/kg/day and will be tapered and off within 6 months. If a patient fails to achieve BVAS=0, an investigator can postpone the procedure of stopping prednisolone (prednisolone 5mg/day x 2 weeks, 4mg/day x 2 weeks, 3mg/day x 4 weeks, 2mg/day x 4 weeks, 1mg/day x 4 weeks, then off prednisolone). Once starting the procedure, prednisolone must be off after 16 weeks. Patients will also receive rituximab (375mg/m2/w x4). After achieving remission, patients will be receive rituximab (1g/body or 0.5g/bodyx2) every 6 months as remission maintenance therapy.
Prednisolone will be commenced with dose of 1.0mg/kg/day and will be tapered to 10mg/day within 6 months. Patients will also receive rituximab (375mg/m2/w x4). After achieving remission, patients will be receive rituximab (1g/body or 0.5g/bodyx2) every 6 months as remission maintenance therapy. There's no limitation by the protocol regarding further prednisolone tapering.