Skip to main content
OpenTrials
Completed

NCT Number: NCT02169219

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Granulomatosis With Polyangiitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Immune System Diseases Lung Diseases Lung Diseases, Interstitial Microscopic Polyangiitis Nervous System Diseases Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucocorticoids

Drug

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 names: Prednisone

Rituximab

Drug

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

Other names: Rituxan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis

Acronym: SCOUT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 23, 2014
Registry last updated
Jun 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.