NCT02169219

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

Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-08-17
• Completion: 2017-11-01
• First posted: 2014-06-23
• Last updated: 2021-06-25
• Results posted: 2018-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study