Clinical Trial: Defining Immune Tolerance in ANCA-associated Vasculitis (AAV)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Defining Immune Tolerance in ANCA-associated Vasculitis (AAV)
Brief 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 Summary:
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markers that define immunological tolerance so that immunotherapy medicines may be correctly changed and safely withdrawn in some people.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Tolerance Biomarker Identification [ Time Frame: Difference from baseline to week 26 ]
Identification of biomarkers associated with clinical tolerance in patients with ANCA-associated vasculitis by comparative immunophenotyping of individual leukocyte subsets from tolerant and non-tolerant patients with AAV.
Due to early study termination, data was not available to evaluate this endpoint.
Original Primary Outcome: Tolerance Biomarker Identification [ Time Frame: Difference from baseline to week 26 ]
Current Secondary Outcome:
- Tolerance Signature Stability [ Time Frame: Baseline to Week 26 ]
Measurement of the stability of a tolerance immune signature in patients with AAV over time.
Due to early study termination, data was not available to evaluate this endpoint.
- Tolerance Signature Versus Clinical Status [ Time Frame: Baseline to Week 26 ]
Correlation of possible changes in the tolerance signature with changes in clinical status.
Due to early study termination, data was not available to evaluate this endpoint.
- Immunosuppression Associated Signature [ Time Frame: Baseline to 8 Weeks Post-Immunosuppression Withdrawal ]
Definition of an immune signature associated with maintenance immunosuppression.
Due to early study termination, data was not available to evaluate this endpoint.
Original Secondary Outcome:
- Tolerance Signature Stability [ Time Frame: Baseline to Week 26 ]Measurement of the stability of a tolerance immune signature in patients with AAV over time.
- Tolerance Signature vs. Clinical Status [ Time Frame: Baseline to Week 26 ]Correlation of possible changes in the tolerance signature with changes in clinical status.
- Immunosuppression Associated Signature [ Time Frame: Baseline to 8 Weeks Post-Immunosuppression Withdrawal ]Definition of an immune signature associated with maintenance immunosuppression.
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: August 29, 2013
Date Started: December 2013
Date Completion:
Last Updated: April 13, 2016
Last Verified: April 2016
