ANCA-associated Vasculitis Clinical Trial
Official title:
A Pilot Study Examining the Effect of Abatacept in ANCA Associated Vasculitis
The purpose of this study is to investigate whether abatacept can prevent relapse in patients with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled trial.
The drugs that are normally used to treat patients with AAV are quite effective, but up to
20% of patients relapse within 18 months. The drugs used can also have significant side
effects. Abatacept, also known as CTLA4Ig, acts by blocking vital costimulatory signals
required for T lymphocytes to be activated. As ANCA associated vasculitis is believed to be
an autoimmune condition and dependent on autoreactive T cells, there is some reason to
believe this drug would be effective. Abatacept has already received a license by the FDA
for use in Rheumatoid arthritis where it has proven to be effective even in patients
unresponsive to Etanercept (TNF blockade).
120 patients with AAV will be invited to take part in this study, from hospitals in the UK
and Europe. The patients will receive standard therapy with methotrexate and steroids as
well as 12 months of abatacept or placebo. They will be followed for a further 12 months.
The primary objective of this study is to assess the relapse rate over 24 months, in
patients with acute AAV, presenting at first diagnosis or relapse, in the two arms of the
study.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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