Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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)

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

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.

Condition or disease Intervention/treatment Phase
Granulomatosis With Polyangiitis Microscopic Polyangiitis Drug: Glucocorticoids Drug: Rituximab Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis
Study Start Date : June 2014
Actual Primary Completion Date : August 17, 2016
Actual Study Completion Date : November 1, 2017


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  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.

  4. 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

  5. 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

  6. 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

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169219


Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Genentech, Inc.
Investigators
Layout table for investigator information
Principal Investigator: John H Stone, MD Massachusetts General Hospital and Harvard Medical School
  Study Documents (Full-Text)

Documents provided by Stone, John H, M.D., M.P.H, Massachusetts General Hospital:

Layout table for additonal information
Responsible Party: Stone, John H, M.D., M.P.H, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02169219     History of Changes
Other Study ID Numbers: 2012P001427
First Posted: June 23, 2014    Key Record Dates
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Vasculitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Prednisone
Rituximab
Glucocorticoids
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal