CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Glucocorticoids +1 moredrug
Likely dose
Glucocorticoids 60mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02169219
NCT02169219Phase 4Completed
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Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis

Massachusetts General Hospital·interventional·Posted Jun 23, 2014·Updated Jun 25, 2021

In Brief

A Phase 4 clinical trial evaluating Glucocorticoids and Rituximab for Granulomatosis With Polyangiitis and Microscopic Polyangiitis. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGranulomatosis With Polyangiitis, Microscopic Polyangiitis
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartJun 1, 2014
Primary CompletionAug 17, 2016
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.0 years ago

Interventions

Glucocorticoidsdrug

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

Rituximabdrug

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