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This pilot study evaluates a short course of glucocorticoids combined with Rituximab for treating ANCA-associated vasculitis. Adults aged 18-85 with a new diagnosis or a flare of GPA or MPA and active disease were able to take part. The study was carried out in Phase 4 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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