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Low-dose Glucocorticoid Vasculitis Induction Study (LoVAS)

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Rituximab
Glucocorticoids
Sponsored by
Chiba University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  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 ANCA-associated vasculitis) consistent with the 2012 Chapel Hill consensus definitions
  4. Positive test by ELISA for proteinase 3-ANCA or myeloperoxidase-ANCA

Exclusion Criteria:

  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

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

Arm Type

Experimental

Active Comparator

Arm Label

Low-dose glucocorticoid

High-dose glucocorticoid

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion of the patients achieving remission
Remission; BVAS ver.3=0 (or 1 with only one minor and persistent BVAS item) and prednisolone <10mg/day

Secondary Outcome Measures

Time to remission
Remission; BVAS ver.3=0 (or 1 with only one minor and persistent BVAS item) and prednisolone <10mg/day
Overall survival, disease free survival, time to end-stage renal disease, time to the first serious adverse event
Assessed by Kaplan-Meier curves
Proportions of death, relapse, end-stage renal disease and the composite of these
Assessed by Kaplan-Meier curves
Proportions of major relapse
major relapse is relapse with one or more BVAS major items
Birmingham Vasculitis Activity Score (BVAS) version 3
BVAS is a scoring system for assessing disease activity of vasculitis
Vasculitis Damage Index (VDI)
VDI is a scoring system for assessing irreversible disease damage due to vasculitis
Short-Form 36 (SF-36)
SF-36 is a scoring system for assessing patient QOL.
Patient global assessment (visualised analogue scale)
global assessments for disease activity and treatment toxicity
Accumulative dose of glucocorticoids
Accumulative dose of glucocorticoids during the study period
Numbers of events of adverse events/serious adverse events, proportions of the patients with adverse events/serious adverse events
Event numbers and proportion of the patients with one or more events are assessed.
Proportions of the patients with new onset diabetes mellitus
diabetes mellitus requiring drug treatments
Proportion of the patients with new onset insomnia
insomnia requiring drug treatments
Proportion of the patients with new onset bone fracture, bone density
bone density is assessed at lumber spines
Number of infections, proportions of the patients with infection
infections requiring drug treatments
Proportions of the patients with new onset hypertension
hypertension requiring drug treatments
Proportions of the patients with new onset hyperlipidemia
hyperlipidemia requiring drug treatments
Proportions of patients achieving remission and discontinuance of glucocorticoids
Remission is BVAS ver3=0 and prednisolone <10mg/day.

Full Information

First Posted
July 18, 2014
Last Updated
January 25, 2021
Sponsor
Chiba University
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1. Study Identification

Unique Protocol Identification Number
NCT02198248
Brief Title
Low-dose Glucocorticoid Vasculitis Induction Study
Acronym
LoVAS
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chiba University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.
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/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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Microscopic Polyangiitis, Wegener Granulomatosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose glucocorticoid
Arm Type
Experimental
Arm Description
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.
Arm Title
High-dose glucocorticoid
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan
Intervention Description
Patients will be administered rituximab (375mg/m2/w x4 infusions) for reducing glucocorticoid dose in remission induction phase.
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Other Intervention Name(s)
Predonine, Prednisolone
Intervention Description
"Low-dose" group commenced 0.5mg/kg/day, then taper and stop within 6 months following pre-defined schedule. "High-dose" group commenced 1.0mg/kg/day, then taper to 10mg/day within 6 months following pre-defined schedule.
Primary Outcome Measure Information:
Title
Proportion of the patients achieving remission
Description
Remission; BVAS ver.3=0 (or 1 with only one minor and persistent BVAS item) and prednisolone <10mg/day
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Time to remission
Description
Remission; BVAS ver.3=0 (or 1 with only one minor and persistent BVAS item) and prednisolone <10mg/day
Time Frame
assessed at 1, 2, 4 and 6 months
Title
Overall survival, disease free survival, time to end-stage renal disease, time to the first serious adverse event
Description
Assessed by Kaplan-Meier curves
Time Frame
0-24 months
Title
Proportions of death, relapse, end-stage renal disease and the composite of these
Description
Assessed by Kaplan-Meier curves
Time Frame
at 6 and 24 months
Title
Proportions of major relapse
Description
major relapse is relapse with one or more BVAS major items
Time Frame
at 24 months
Title
Birmingham Vasculitis Activity Score (BVAS) version 3
Description
BVAS is a scoring system for assessing disease activity of vasculitis
Time Frame
assessed at 0, 1, 2, 4, 6, 9, 12, 18 and 24 months
Title
Vasculitis Damage Index (VDI)
Description
VDI is a scoring system for assessing irreversible disease damage due to vasculitis
Time Frame
assessed at 0, 6, 12, 18 and 24 months
Title
Short-Form 36 (SF-36)
Description
SF-36 is a scoring system for assessing patient QOL.
Time Frame
assessed at 0, 6, 12, 18 and 24 months
Title
Patient global assessment (visualised analogue scale)
Description
global assessments for disease activity and treatment toxicity
Time Frame
assessed at 0, 6, 12, 18 and 24 months
Title
Accumulative dose of glucocorticoids
Description
Accumulative dose of glucocorticoids during the study period
Time Frame
assessed at 6 and 24 months
Title
Numbers of events of adverse events/serious adverse events, proportions of the patients with adverse events/serious adverse events
Description
Event numbers and proportion of the patients with one or more events are assessed.
Time Frame
at 6 and 24 months
Title
Proportions of the patients with new onset diabetes mellitus
Description
diabetes mellitus requiring drug treatments
Time Frame
at 6 and 24 months
Title
Proportion of the patients with new onset insomnia
Description
insomnia requiring drug treatments
Time Frame
at 6 and 24 months
Title
Proportion of the patients with new onset bone fracture, bone density
Description
bone density is assessed at lumber spines
Time Frame
at 6 and 24 months
Title
Number of infections, proportions of the patients with infection
Description
infections requiring drug treatments
Time Frame
at 6 and 24 months
Title
Proportions of the patients with new onset hypertension
Description
hypertension requiring drug treatments
Time Frame
at 6 and 24 months
Title
Proportions of the patients with new onset hyperlipidemia
Description
hyperlipidemia requiring drug treatments
Time Frame
at 6 and 24 months
Title
Proportions of patients achieving remission and discontinuance of glucocorticoids
Description
Remission is BVAS ver3=0 and prednisolone <10mg/day.
Time Frame
at 6 and 24 months
Other Pre-specified Outcome Measures:
Title
Serum immunoglobulin levels
Description
Serum immunoglobulin levels
Time Frame
assessed at 0, 1, 2, 4, 6, 9, 12, 18 and 24 months
Title
Peripheral blood B cell counts
Description
CD19 positive B cells assessed by FACS
Time Frame
assessed at 0, 1, 2, 4, 6, 9, 12, 18 and 24 months
Title
serum MPO-/PR3-ANCA levels measured by ELISA
Description
MPO-ANCA and PR3-ANCA are disease specific autoantibodies binding neutrophil cytoplasmic antigen.
Time Frame
assessed at 0, 1, 2, 4, 6, 9, 12, 18 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroshi Nakajima, M.D., Ph.D
Organizational Affiliation
Chiba University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asahi General Hospital
City
Asahi
State/Province
Chiba
Country
Japan
Facility Name
Kameda Medical Centre
City
Kamogawa
State/Province
Chiba
Country
Japan
Facility Name
Matsudo City Hospital
City
Matsudo
State/Province
Chiba
Country
Japan
Facility Name
Japanese Red Cross Narita Hospital
City
Narita
State/Province
Chiba
Country
Japan
Facility Name
Shimoshizu Hospital
City
Yotsukaido
State/Province
Chiba
Country
Japan
Facility Name
Hokkaido University
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Yokohama Rosai Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Saitama Medical Center
City
Kawagoe
State/Province
Saitama
Country
Japan
Facility Name
Dokkyo Medical University
City
Mibu
State/Province
Tochigi
Country
Japan
Facility Name
Teikyo University
City
Itabashi
State/Province
Tokyo
Country
Japan
Facility Name
Keio University Hospital
City
Shinanomachi
State/Province
Tokyo
Country
Japan
Facility Name
Akita University
City
Akita
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Chiba Aoba Municipal Hospital
City
Chiba
Country
Japan
Facility Name
Chiba East Hospital
City
Chiba
Country
Japan
Facility Name
Fukushima Medical University
City
Fukushima
Country
Japan
Facility Name
Niigata University
City
Niigata
Country
Japan

12. IPD Sharing Statement

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Low-dose Glucocorticoid Vasculitis Induction Study

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