NCT01934504

Defining Immune Tolerance in ANCA-associated Vasculitis (AAV)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of the study is to find biological markers (certain proteins or cellular markers found in a blood test) that will inform doctors which patients diagnosed with ANCA-associated vasculitis (AAV) are most likely to be able to stop their medications suppressing their immune systems and remain in remission.

Detailed description

Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) are small vessel vasculitides that typically follow a chronic course and are associated with serious illness and death.Three clinical conditions are recognized: microscopic polyangiitis (MPA); granulomatosis with polyangiitis (Wegener's, GPA); and eosinophilic granulomatosis with polyangiitis (EPA, formerly Churg Strauss Syndrome). Though these conditions have different clinical features, they can have overlapping immunological characteristics. The precise cause of AAV is not understood, but there are clear genetic associations which, in the context of predisposing environmental factors, such as infections, may lead to development of disease. There are no diagnostic criteria for AAV, but there are validated classification criteria and disease definitions. There is a need to find biological markers that define immunological tolerance so that immunotherapy medicines may be correctly changed and safely withdrawn in some people.

Conditions

• ANCA-Associated Vasculitis

Interventions

Type	Name	Description
PROCEDURE	Venipuncture for blood sample collection	Analysis samples from the blood sample collection at specific time points.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-09-04
• Last updated: 2016-05-20
• Results posted: 2016-05-20

Locations

3 sites across 1 country: United Kingdom