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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Granulomatosis With Polyangiitis; Microscopic Polyangiitis

Treatments: Drug: Rituximab; Drug: Glucocorticoids

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02169219

2012P001427

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ages 18-85 years old
• Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference
• New diagnosis or disease flare with a Birmingham Vasculitis Activity Score/Wegener's granulomatosis (BVAS/WG) of > 3

Exclusion criteria

• Renal disease in patients with PR3-ANCA as defined by any of the following:
• Urinary red blood cell casts
• Biopsy-proven glomerulonephritis
• Increase in serum creatinine of >30% over baseline
• Severe renal disease in patients with MPO-ANCA as defined by both of the following:
• Urinary red blood cell casts or biopsy-proven glomerulonephritis
• Estimated glomerular filtration rate < 30 ml/min/1.73m2
• Diffuse alveolar hemorrhage requiring ventilatory support
• GC treatment for longer than 14 days prior to enrollment unless patient has been on a stable maintenance dose of prednisone at the time of the flare
• Daily oral cyclophosphamide within 1 month prior to enrollment
• Completed a remission induction course of cyclophosphamide or rituximab within 4 months of enrollment
• Hepatitis B infection
• HIV infection
• History of anti-GBM disease
• Other uncontrolled disease, including drug and alcohol abuse, that may interfere with the study
• Pregnancy or breastfeeding
• History of severe allergic reactions to human or chimeric monoclonal antibodies

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Glucocorticoids and Rituximab

Experimental group

Description:

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.

Treatment:

Drug: Glucocorticoids

Drug: Rituximab