Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis
Anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis is a life-threatening
systemic inflammatory autoimmune disease. Current treatment regimes using corticosteroids
and cyclophosphamide have improved patient survival but are associated with treatment
associated morbidity and mortality. Tumour necrosis factor alpha (TNF) is a proinflammatory
cytokine which has been implicated in the pathogenesis of ANCA vasculitis. Anti-TNF
therapies have been used successfully in the management of other inflammatory autoimmune
diseases. This phase II cohort study has been designed to investigate the safety and
efficacy of anti-TNF monoclonal antibody (Infliximab) therapy for patients with ANCA
associated vasculitis when used in addition to standard immunosuppressive therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
0, 6, 10, 14, 26, 39 and 52 weeks
No
Lorraine Harper, PhD
Principal Investigator
University of Birmingham
United Kingdom: Research Ethics Committee
RRK2031
NCT00753103
January 2003
July 2006
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