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

NCT ID: NCT02169219

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-11-01

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.

Conditions

Granulomatosis With Polyangiitis; Microscopic Polyangiitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Glucocorticoids

Intervention Type: 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

Rituximab

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Rituximab

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

Intervention Type: DRUG

Other Intervention Names

Prednisone; Rituxan

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stone, John H, M.D., M.P.H

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John H Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital and Harvard Medical School

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2012P001427

Identifier Type: -

Identifier Source: org_study_id