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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02169219
Other study ID # 2012P001427
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 2014
Est. completion date November 1, 2017

Study information

Verified date June 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 1, 2017
Est. primary completion date August 17, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Remission 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. 6 months
Secondary Disease Response 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. 4 weeks
Secondary Partial Remission Number of patients entering partial remission, defined as no new disease manifestations, no worsening of existing disease and BVAS/WG < 3. 8 weeks
Secondary Sustained Complete Remission Number of patients entering sustained remission defined as BVAS/WG = 0, prednisone dose = 0 and no disease flares during the study period. 6 months
Secondary Limited Flares 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 6 months
Secondary Severe Flares Number of severe flares defined as flare with BVAS/WG > 3 or experiencing one of the major BVAS/WG items 6 months
Secondary Early Treatment Failures Number of early treatment failures defined as patients who have new or worsening disease manifestations assessed at 4 weeks after study entry 4 weeks
Secondary Vasculitis Damage Index (VDI) 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. 24 months
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