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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02169219
Phase
PHASE4
Status
Completed

Conditions

  • Granulomatosis With Polyangiitis
  • Microscopic Polyangiitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2014
Status verified
Jun 2021
Primary completion
Aug 17, 2016
Completion
Nov 1, 2017

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Complete Remission [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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