A Phase 2 interventional study of Infliximab and Cyclophosphamide in Wegener's Granulomatosis, Renal Limited Vasculitis and Microscopic Polyangiitis, sponsored by University Hospital Birmingham NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-16.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Phase 2, Interventional, and Treatment
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.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 19 are open to participants now.
This study's enrollment of 37 is below the median of 70 across 67 interventional studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →University Hospital Birmingham NHS Foundation Trust is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy
Biological: Infliximab · Drug: Cyclophosphamide · Drug: Prednisolone · Drug: Azathioprine · Drug: Mycophenolate mofetil · Drug: Methylprednisolone
Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
Drug: Cyclophosphamide · Drug: Prednisolone · Drug: Azathioprine · Procedure: Plasma exchange · Drug: Mycophenolate mofetil · Drug: Methylprednisolone
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
Also known as: Remicade
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
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.
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
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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Granulomatosis with Polyangiitis→
University Hospital Birmingham NHS Foundation Trust