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

NCT02169219 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-06-25

Study results available
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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.

Conditions

  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis

Interventions

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

DRUG

Rituximab

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

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • John H Stone, MD · Massachusetts General Hospital and Harvard Medical School

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-08-17
Completion
2017-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169219 on ClinicalTrials.gov