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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis

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 Summary:

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.


Sponsor: Massachusetts General Hospital

Current Primary Outcome: Complete remission [ Time Frame: 6 months ]

Number of patients entering remission defined as BVAS/WG = 0 and prednisone dose = 0.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: June 19, 2014
Date Started: June 2014
Date Completion: December 2018
Last Updated: February 7, 2017
Last Verified: February 2017