CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 197 enrolled
Drug / intervention
Rituximab plus cyclophosphamide placebo (rituximab group) +4 moredrug
Likely dose
Rituximab 375 mg/m² intravenous infusion once weekly for 4 weeks; cyclophosphamide 2 mg/kg/day orally for months 1-3; azathioprine 2 mg/kg/day orally for months 4-6; prednisone 1 mg/kg/day orally (not to exceed 80 mg/day) during induction phase with taper completed by month 6AI-extracted
Key inclusion· 4
  • ✓Diagnosis of Wegener's granulomatosis or microscopic polyangiitis per Chapel Hill Consensus Conference definitions
  • ✓Newly diagnosed OR experiencing disease flare with BVAS/WG ≥3 or disease severe enough to require cyclophosphamide treatment
  • ✓Positive for PR3-ANCA or MPO-ANCA at screening
  • ✓Weight at least 88 pounds (40 kilograms)
Key exclusion· 12
  • ✕Diagnosis of Churg-Strauss Syndrome
  • ✕Limited disease that would not normally be treated with cyclophosphamide
  • ✕Requires mechanical ventilation due to alveolar hemorrhage
  • ✕History of severe allergic reactions to human or chimeric monoclonal antibodies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00104299
NCT00104299Phase 3Completed
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Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 25, 2005·Updated Apr 21, 2017

In Brief

A Phase 3 clinical trial evaluating Rituximab plus cyclophosphamide placebo (rituximab group), Cyclophosphamide plus rituximab placebo (control group), and 3 other interventions for Vasculitis and 2 related conditions. Completed, enrolled 197 participants across 8 sites in 2 countries.

Detailed Summary

Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA. Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
CountriesNetherlands, United States
CollaboratorsImmune Tolerance Network (ITN), Genentech, Inc.

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 25, 2005
Enrollment StartJan 1, 2005
Primary CompletionDec 1, 2008
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 21.4 years ago

Interventions

Rituximab plus cyclophosphamide placebo (rituximab group)drug

375 mg/m\^2 infusions once weekly for 4 week

Cyclophosphamide plus rituximab placebo (control group)drug

2 mg/kg/day orally for months 1-3

Azathioprinedrug

2 mg/kg/day orally for months 4-6

Methylprednisolone (or other glucocorticoid)drug

1 g/day intravenously for up to 3 days within 14 days prior to receiving rituximab

Prednisonedrug

During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.