Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis (SCOUT)
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|ClinicalTrials.gov Identifier: NCT02169219|
Recruitment Status : Completed
First Posted : June 23, 2014
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Granulomatosis With Polyangiitis Microscopic Polyangiitis||Drug: Glucocorticoids Drug: Rituximab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||August 17, 2016|
|Actual Study Completion Date :||November 1, 2017|
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.
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:
Other Name: Prednisone
Rituximab will be administered in four weekly doses at 375mg/m2
Other Name: Rituxan
- Complete Remission [ Time Frame: 6 months ]We examined whether an 8-week glucocorticoid course in combination with rituximab (RTX) would induce disease remission in patients with AAV. The primary outcome was disease remission off steroids at 6 months.
- 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 at 4 weeks.
- 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
- Vasculitis Damage Index (VDI) [ Time Frame: 24 months ]The Vasculitis Damage Index (VDI) is a single-page catalog of damage items separated into 11 groupings of items by organ system. There are a total of 60 items. Each item is recorded if it occurred since the onset of vasculitis, has been present for at least 3 months, or occurred at least 3 months ago. Each item of damage is scored as present (1) or absent (0), yielding a maximum score of 60.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169219
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||John H Stone, MD||Massachusetts General Hospital and Harvard Medical School|