Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis
Completed · Phase 4
Conditions studied: Granulomatosis With Polyangiitis, Microscopic Polyangiitis
In brief
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.
Key facts
- Study ID
- NCT02169219
- Run by
- Massachusetts General Hospital
- People needed
- 20
- Starts
- 2014-06-01
- Expected to finish
- 2017-11-01
- Last updated by the study team
- 2021-06-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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