The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm antibody (ANCA) 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
Daily oral 2 mg/kg or pulsed intravenous 15mg/kg every 2-3 weeks for 3-6 months (until patient has been in remission for 3 months).
Daily oral 1mg/kg tapered over 12 months
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1)
Time frame: 0, 6, 10, 14, 26, 39 and 52 weeks
Adverse events
Time frame: Weeks 2, 6, 10, 14, 26, 39, 52
Vasculitis Damage Index Score
Time frame: Weeks 0, 14, 26, 39, 52
Renal function
Time frame: Weeks 0, 2, 6, 10, 14, 26, 39, 52
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Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Additional therapy for patients with severe vasculitis (creatinine \> 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
500 mg intravenous infusion daily for three days at lead physicians discretion.