Unique ID issued by UMIN | UMIN000014222 |
---|---|
Receipt number | R000016553 |
Scientific 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 |
Date of disclosure of the study information | 2014/08/01 |
Last modified on | 2022/12/15 11:42:41 |
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
LoVAS
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
LoVAS
Japan |
ANCA-associated vasculitis
Clinical immunology |
Others
NO
To demonstrate non-inferiority of efficacy of low-dose glucocorticoids plus rituximab against high-dose glucocorticoids plus rituximab in remission induction in ANCA-associated vasculitis
Efficacy
Confirmatory
Phase IV
Proportion of the patients achieving remission within 6 months
<Efficacy>
(1) Time to remission
(2) Overall survival, disease free survival, time to end-stage renal disease, time to the first serious adverse event
(3) Proportions of death, relapse, end-stage renal disease and the composite of these (6 months and 24 months)
(4) Proportions of severe relapse
(5)Proportions of the patients achieving remission and stopping glucocorticoids
(6) BVAS ver3
(7) VDI
(8) SF-36
(9) Patient global assessment (visualised analogue scale)
(10) accumulative dose of glucocorticoids
<safety>
(1) Numbers of events of adverse events/serious adverse events, proportions of the patients with adverse events/serious adverse events
(2) Proportions of the patients with new onset diabetes mellitus, hypertension and hyperlipidemia
(3) Proportion of the patients with new onset insomnia
(4) Proportion of the patients with new onset bone fracture, bone density
(5) Number of infections, proportions of the patients with infection
<Exploratory>
(1) Serum immunoglobulin levels
(2) Peripheral blood B cell counts
(3) MPO-/PR3-ANCA levels
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
2
Treatment
Medicine |
low-dose glucocorticoids plus rituximab
(prednisolone0.5mg/kg/day+rituximab375mg/m2/wx4)
high-dose glucocorticoids plus rituximab
(prednisolone1.0mg/kg/day+rituximab375mg/m2/wx4)
20 | years-old | <= |
Not applicable |
Male and Female
To be included in the trial patients must must have:
(1) Provision of written informed consent by a patient or a surrogate decision maker
(2) Age=>20 years
(3) New clinical diagnosis of ANCA-associated vasculitis (granulomatosis with polyangiitis, microscopic polyangiitis or renal limited vasculitis) consistent with the 2012 Chapel Hill consensus definitions
(4) Positive test by ELISA for proteinase 3-ANCA or myeloperoxidase-ANCA
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
140
1st name | Hiroshi |
Middle name | |
Last name | Nakajima |
Chiba University Hospital
Allergy and Clinical Immunology
2608670
1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
043-222-7171
nakajimh@faculty.chiba-u.jp
1st name | Shunsuke |
Middle name | |
Last name | Furuta |
Chiba University Hospital
Clinical Research Center
2608670
1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
043-222-7171
shfuruta@chiba-u.jp
Chiba University Hospital
Chiba University Hospital
Self funding
Japan
Chiba University Hospital
1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan
043-222-7171
shiken@office.chiba-u.jp
NO
2014 | Year | 08 | Month | 01 | Day |
https://www.m.chiba-u.jp/dept/allergy-clin-immunol/files/3315/9893/5994/protocol_2.5.pdf
Published
https://clinicaltrials.gov/ct2/show/NCT02198248
140
Remission rates: Low-dose group 71% vs High-dose group 69%
2022 | Year | 12 | Month | 15 | Day |
Reduced-dose (n = 69) vs High-dose (n = 65)
Age, median, y 73 vs 74
Female 43 vs 37
Male 26 vs 28
Microscopic polyangiitis 53 vs 51
Granulomatosis with polyangiitis 16 vs 13
Renal-limited vasculitis 0 vs 1
Between November 2014 and June 2019, a total of 140 patients with ANCA-associated vasculitis were enrolled in this study. Of these patients, 70 were randomly assigned to receive the reduced-dose regimen and 70 to receive the high-dose regimen. Five in the high-dose group and 1 in the reduced-dose group were excluded from analysis. There was 1 dropout in each treatment group.
Twenty-one serious adverse events occurred in 13 patients in the reduced-dose group (18.8%), while 41 occurred in 24 patients in the high-dose group (36.9%). Seven serious infections occurred in 5 patients in the reduced-dose group (7.2%), while 20 occurred in 13 patients in the high-dose group (20.0%).
Reduced-dose (n = 69) vs High-dose (n = 65)
Relapse 9 vs 5
Deaths 2 vs 5
End-stage kidney disease 0 vs 1
Completed
2014 | Year | 06 | Month | 18 | Day |
2014 | Year | 06 | Month | 18 | Day |
2014 | Year | 09 | Month | 30 | Day |
2021 | Year | 09 | Month | 30 | Day |
2021 | Year | 12 | Month | 30 | Day |
2022 | Year | 03 | Month | 30 | Day |
2022 | Year | 03 | Month | 30 | Day |
2014 | Year | 06 | Month | 10 | Day |
2022 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016553
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