Status:
UNKNOWN
Low-dose Glucocorticoid Vasculitis Induction Study
Lead Sponsor:
Chiba University
Conditions:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Microscopic Polyangiitis
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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...
Detailed 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/resp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT02198248
Start Date
October 1 2014
End Date
June 1 2021
Last Update
January 27 2021
Active Locations (17)
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1
Asahi General Hospital
Asahi, Chiba, Japan
2
Kameda Medical Centre
Kamogawa, Chiba, Japan
3
Matsudo City Hospital
Matsudo, Chiba, Japan
4
Japanese Red Cross Narita Hospital
Narita, Chiba, Japan