Clinical Trial: Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study

Brief Summary: Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the long-term safety and efficacy of this drug is not yet clear. This study proposes to follow patients who were enrolled in the RAVE study to determine if treatment with rituximab influences long-term outcomes.

Detailed Summary:
Sponsor: Johns Hopkins University

Current Primary Outcome: Long-term safety of rituximab for the treatment of ANCA-associated vasculitis [ Time Frame: Four years ]

To determine the long-term safety of rituximab for the treatment of ANCA-associated vasculitis (granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease activity [ Time Frame: Four years ]
    Disease activity, assessed by the proportion of patients with severe flares
  • Disease damage [ Time Frame: Four years ]
    Disease damage, assessed by the increase in VDI and AVID scores from baseline
  • Renal survival [ Time Frame: Four years ]
    Renal survival, assessed by the proportion of patients doubling their serum creatinine, reaching Stage V Chronic Kidney Disease (defined as a glomerular filtration rate ≤15 ml/min), or both.
  • Malignancy [ Time Frame: Four years ]
    Proporition of patients with incident malignancies, including type of malignancy


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: April 25, 2012
Date Started: May 2012
Date Completion:
Last Updated: April 25, 2012
Last Verified: April 2012