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

Johns Hopkins University67 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Granulomatosis With Polyangiitis Microscopic Polyangiitis

Interventions

ObservationalOTHER

Observational study of subjects previously enrolled in the RAVE trial

Eligibility

Sex: ALLMin age: 12 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Enrollment in the RAVE trial 2. Completion of RAVE Common Closeout Date visit 3. Informed consent Exclusion Criteria: 1. Refusal to participate 2. Inability to comply with standard-of-care, including routine clinical visits and testing.

Locations (8)

University of Alabama

Birmingham, Alabama, United States

Johns Hopkins University

Baltimore, Maryland, United States

Boston University

Boston, Massachusetts, United States

Mayo Clinic Foundation

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Long-term safety of rituximab for the treatment of ANCA-associated vasculitis

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

Time frame: Four years

Secondary Outcomes

Disease activity

Disease activity, assessed by the proportion of patients with severe flares

Time frame: Four years

Disease damage assessed by the increase in Vasculitis Damage Index (VDI)

The VDI is composed of 11 categories (e.g., musculoskeletal, pulmonary) and 64 individual damage items. The score ranges from 0 (no damage) to 64 (all individual damage items).

Time frame: Four years

Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)

The AVID has 12 categories and 112 individual damage items. The score ranges from 0 (no damage) to 129 (all individual damage items). Although there are 112 items, 17 items are related to eyes and ears and can be scored for left, right or both.

Time frame: Four years

Renal survival

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.

Time frame: Four years

Malignancy

Proportion of patients with incident malignancies, including type of malignancy

Time frame: Four years

Data from ClinicalTrials.gov

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