ow-dose glucocorticoids plus rituximab versus high-dose glucocorticoids plus rituximab for remission induction in ANCA-associated vasculitis; a multicentre, open label, randomised control trial
- Conditions
- ANCA-associated vasculitis
- Registration Number
- JPRN-UMIN000014222
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Remission rates: Low-dose group 71% vs High-dose group 69%
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Not provided
The presence of any of the following will preclude patient inclusion: (1) Prior treatment for ANCA-associated vasculitis before trial entry (2) ANCA-associated vasculitis related glomerulonephritis (eGFR<15ml/min) or alveolar hemorrhage (oxygen inhalation >2L/min) (3) Presence of another multisystem autoimmune disease (4) Known infection with HIV; a past or current history of hepatitis B virus or hepatitis C virus infection (5) Desire to bear children, pregnancy or lactating (6) History of malignancy within the past 5 years or any evidence of persistent malignancy (7) Ongoing or recent (last 1 year) evidence of active tuberculosis (8) Severe allergy or anaphylaxis to monoclonal antibody therapy (9) Any concomitant condition anticipated to likely require oral systemic glucocorticoids, immunosuppressants, biologics, plasma exchange or IVIg (10) Any biological B cell depleting agent (such as rituximab or belimumab) within the past 6 months (11) Other conditions, in the investigator's opinion, inappropriate for the trial entry
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of the patients achieving remission within 6 months
- Secondary Outcome Measures
Name Time Method