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Trial record 7 of 15 for:    "Anca-Associated Vasculitis" | "Prednisolone hemisuccinate"

Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis (SCOUT)

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ClinicalTrials.gov Identifier: NCT02169219
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Stone, John H, M.D., M.P.H, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Interventions Drug: Glucocorticoids
Drug: Rituximab
Enrollment 20
Recruitment Details
  • New diagnosis or flare of previously diagnosed disease in patients followed in the Massachusetts General Hospital (MGH) Rheumatology or Nephrology Units.
  • New diagnosis or flare of previously diagnosed disease in patients hospitalized at MGH.
Pre-assignment Details  
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
Period Title: Overall Study
Started 20
Completed 14
Not Completed 6
Reason Not Completed
Lack of Efficacy             6
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description

This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.

Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.

Prednisone will be tapered over 8 weeks as follows:

  • 60mg for 2 weeks
  • 40mg for 2 weeks
  • 30mg for 1 week
  • 20mg for 1 week
  • 10mg for 1 week
  • 5mg for 1 week

Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years 0
Between 18 and 65 years 16
>=65 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
13
  65.0%
Male
7
  35.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Birmingham Vasculitis Activity Score for Wegener's Granulomatosis(BVAS/WG)   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
5
(3 to 11)
[1]
Measure Description: Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis(BVAS/WG, range 0-64). The total score is composed of 34 predefined items, units on a scale, grouped into 9 organ systems. Each item carries a weight from 1-3, depending on disease severity. Subjects with a score of 3 or higher were invited to participate in the trial. A score of 0 indicates no disease activity; a higher score indicates worsening disease.
Disease group   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Granulomatosis with polyangiitis (GPA) 14
Microscopic polyangiitis (MPA) 6
Indeterminate 0
[1]
Measure Description: Disease type (GPA or MPA)
anti-neutrophil cytoplasmic antibody (ANCA)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
myeloperoxidase (MPO) 11
proteinase (PR3) 7
Negative 2
[1]
Measure Description: ANCA type and titer were determined by ELISA.
1.Primary Outcome
Title Complete Remission
Hide Description We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:

Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.

Prednisone will be tapered over 8 weeks as follows:

  • 60mg for 2 weeks
  • 40mg for 2 weeks
  • 30mg for 1 week
  • 20mg for 1 week
  • 10mg for 1 week
  • 5mg for 1 week

Rituximab will be administered in four weekly doses at 375mg/m2

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
14
2.Secondary Outcome
Title Disease Response
Hide Description Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score at 4 weeks.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients having a disease response
Arm/Group Title Rituximab and Glucocorticoids
Hide Arm/Group Description:

Prednisone will be tapered over 8 weeks as follows:

  • 60mg for 2 weeks
  • 40mg for 2 weeks
  • 30mg for 1 week
  • 20mg for 1 week
  • 10mg for 1 week
  • 5mg for 1 week

Rituximab administered in 4 weekly doses at 375 mg/m2

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
3.Secondary Outcome
Title Partial Remission
Hide Description Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:
All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
4.Secondary Outcome
Title Sustained Complete Remission
Hide Description Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:
All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
14
  70.0%
5.Secondary Outcome
Title Limited Flares
Hide Description Number of limited flares defined as a new occurrence or worsening of one or more minor BVAS/WG items and a total BVAS/WG ≤ 3
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:

Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.

Prednisone will be tapered over 8 weeks as follows:

  • 60mg for 2 weeks
  • 40mg for 2 weeks
  • 30mg for 1 week
  • 20mg for 1 week
  • 10mg for 1 week
  • 5mg for 1 week

Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.0%
6.Secondary Outcome
Title Severe Flares
Hide Description Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:

This is a single-arm trial. All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.

Glucocorticoids: Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.

Prednisone will be tapered over 8 weeks as follows:

  • 60mg for 2 weeks
  • 40mg for 2 weeks
  • 30mg for 1 week
  • 20mg for 1 week
  • 10mg for 1 week
  • 5mg for 1 week

Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
5
  25.0%
7.Secondary Outcome
Title Early Treatment Failures
Hide Description Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:
All patients receive both rituximab and glucocorticoids. The protocol calls for the discontinuation of prednisone within two months of the baseline visit.
Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
0
8.Secondary Outcome
Title Vasculitis Damage Index (VDI)
Hide Description The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description:
Measure Description: Disease damage was assessed by the Vasculitis Damage Index (VDI) at baseline and end of study
Overall Number of Participants Analyzed 20
Mean (Inter-Quartile Range)
Unit of Measure: units on a scale
Baseline VDI score
0
(0 to 1)
24 month VDI score
0.5
(0 to 2)
Time Frame Reports of unanticipated problems involving risks to subjects or others are to be submitted to the IRB within 5 working days/7 calendar days of the date the investigator first becomes aware of the problem. Adverse events were collected through the 6 month study duration.
Adverse Event Reporting Description

Serious adverse event means any event temporally associated with the subject’s participation in research that meets any of the following criteria:

1) hospitalization or prolonged hospitalization 2.)One severe flare - defined as BVAS/WG ≥ 3 or experiencing one of the major BVAS/WG items) 3.) unexpected and related to the investigation drug

 
Arm/Group Title Glucocorticoids and Rituximab
Hide Arm/Group Description

Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.

Prednisone will be tapered over 8 weeks as follows:

  • 60mg for 2 weeks
  • 40mg for 2 weeks
  • 30mg for 1 week
  • 20mg for 1 week
  • 10mg for 1 week
  • 5mg for 1 week

Rituximab: Rituximab will be administered in four weekly doses at 375mg/m2

All-Cause Mortality
Glucocorticoids and Rituximab
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glucocorticoids and Rituximab
Affected / at Risk (%) # Events
Total   11/20 (55.00%)    
Cardiac disorders   
myocardial infarction   1/20 (5.00%)  1
atrial fibrillation,   1/20 (5.00%)  1
Endocrine disorders   
Thyroid maligancy   2/20 (10.00%)  2
Immune system disorders   
Severe flares   5/20 (25.00%)  5
syncope   1/20 (5.00%)  1
Reproductive system and breast disorders   
Uterine malignancy   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glucocorticoids and Rituximab
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Stone
Organization: Massachusetts General Hospital, Division of Rheumatology
Phone: 617-643-2140
EMail: adfernandes@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Stone, John H, M.D., M.P.H, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02169219     History of Changes
Other Study ID Numbers: 2012P001427
First Submitted: June 19, 2014
First Posted: June 23, 2014
Results First Submitted: April 12, 2018
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018