Granulomatosis With Polyangiitis, Microscopic Polyangiitis
Conditions
Keywords
Vasculitis, ANCA, Rituximab, Small vessel vasculitis
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.
Interventions
OTHERObservational
Observational study of subjects previously enrolled in the RAVE trial
Sponsors
University of Alabama at Birmingham
Boston University
Mayo Clinic
Duke University
The Cleveland Clinic
University Medical Center Groningen
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety of rituximab for the treatment of ANCA-associated vasculitis | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease activity | Four years | Disease activity, assessed by the proportion of patients with severe flares |
| Disease damage assessed by the increase in Vasculitis Damage Index (VDI) | Four years | 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). |
| Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID) | Four years | 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. |
| Renal survival | 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 | Four years | Proportion of patients with incident malignancies, including type of malignancy |
Countries
Netherlands, United States
Outcome results
None listed