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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE June 23, 2014
Results First Submitted Date  ICMJE April 12, 2018
Results First Posted Date  ICMJE August 17, 2018
Last Update Posted Date August 17, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Complete Remission [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
Complete Remission [ Time Frame: 6 months ]
Number of patients entering remission defined as BVAS/WG = 0 and prednisone dose = 0.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
  • Disease Response [ Time Frame: 4 weeks ]
    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.
  • Partial Remission [ Time Frame: 8 weeks ]
    Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3.
  • Sustained Complete Remission [ Time Frame: 6 months ]
    Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.
  • Limited Flares [ Time Frame: 6 months ]
    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
  • Severe Flares [ Time Frame: 6 months ]
    Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items
  • Early Treatment Failures [ Time Frame: 4 weeks ]
    Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry
  • Vasculitis Damage Index (VDI) [ Time Frame: 24 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
  • Disease Response [ Time Frame: 4 weeks ]
    Number of patients achieving disease response defined as, no new disease manifestations; no worsening of existing disease; stable or improved BVAS/WG score
  • Partial Remission [ Time Frame: 8 weeks ]
    Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3.
  • Sustained Complete Remission [ Time Frame: 6 months ]
    Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period.
  • Limited Flares [ Time Frame: 6 months ]
    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
  • Severe Flares [ Time Frame: 6 months ]
    Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items
  • Early Treatment Failures [ Time Frame: 4 weeks ]
    Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Official Title  ICMJE Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis
Brief Summary The purpose of this pilot study is to test whether an 8-week course of glucocorticoids, combined with rituximab, is effective in treating ANCA-associated vasculitis.
Detailed Description

The primary aim of this pilot study is to examine whether an 8 week course of glucocorticoids, in combination with rituximab, is effective in inducing and maintaining disease remission for up to 6 months in a subset of patients with ANCA-associated vasculitis (AAV) who have a more favorable prognosis.

This pilot study will enroll 20 patients with active AAV. Close patient follow-up will insure that any patients who require courses of glucocorticoids longer than two months will receive longer therapy, if appropriate for their well-being.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis
Intervention  ICMJE
  • Drug: 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
    Other Name: Prednisone
  • Drug: Rituximab
    Rituximab will be administered in four weekly doses at 375mg/m2
    Other Name: Rituxan
Study Arms  ICMJE Experimental: Glucocorticoids and Rituximab
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.
Interventions:
  • Drug: Glucocorticoids
  • Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2017
Actual Primary Completion Date August 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients ages 18-85 years old
  • Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference
  • New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's granulomatosis (BVAS/WG) of > 3

Exclusion Criteria:

  • Renal disease in patients with PR3-ANCA as defined by any of the following:
  • Urinary red blood cell casts
  • Biopsy-proven glomerulonephritis
  • Increase in serum creatinine of >30% over baseline
  • Severe renal disease in patients with MPO-ANCA as defined by both of the following:
  • Urinary red blood cell casts or biopsy-proven glomerulonephritis
  • Estimated glomerular filtration rate < 30 ml/min/1.73m2
  • Diffuse alveolar hemorrhage requiring ventilatory support
  • GC treatment for longer than 14 days prior to enrollment unless patient has been on a stable maintenance dose of prednisone at the time of the flare
  • Daily oral cyclophosphamide within 1 month prior to enrollment
  • Completed a remission induction course of cyclophosphamide or rituximab within 4 months of enrollment
  • Hepatitis B infection
  • HIV infection
  • History of anti-GBM disease
  • Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
  • Pregnancy or breastfeeding
  • History of severe allergic reactions to human or chimeric monoclonal antibodies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02169219
Other Study ID Numbers  ICMJE 2012P001427
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data will be shared upon request - without personal health information - following completion of the analysis. Inquiries should be directed to the Principal Investigator.
Responsible Party Stone, John H, M.D., M.P.H, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Principal Investigator: John H Stone, MD Massachusetts General Hospital and Harvard Medical School
PRS Account Massachusetts General Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP