5505: Longitudinal Protocol for Granulomatosis with Polyangiitis (Wegener’s) and Microscopic Polyangiitis
Vasculitis Clinical Research Consortium 5505: In the longitudinal studies, clinical and laboratory information will be collected on patients with vasculitis to study the disease over an extended period of time. The data from the longitudinal studies will be used by scientists to study the genetics and causes of vasculitis, find new ways to track disease and predict responses, to understand how to treat patients, and much more.
Target Enrollment: A total of 600 patients with AAV (400 GPA, 200 MPA) will be enrolled.
Patients will have disease in various stages and of different duration. Widely accepted diagnostic criteria-as opposed to classification criteria or definitions-have not yet been developed for Granulomatosis with Polyangiitis (Wegener’s). The Granulomatosis with Polyangiitis (Wegener’s) Etanercept Trial employed a modification of the American College of Rheumatology (ACR) Criteria for the classification of GPA in its eligibility criteria.
In summary, in order to be included, GPA patients will need to meet at least 2 of the 5 modified ACR Criteria for the classification of GPA. MPA patients will need to meet the Chapel Hill Consensus Conference definition of MPA. In addition, in cases of patients diagnosed with either GPA or MPA, a lengthy list of mimickers must be excluded.