NCT00753103

Anti-Cytokine Therapy for Vasculitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University Hospital Birmingham NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Wegener's Granulomatosis
• Renal Limited Vasculitis
• Microscopic Polyangiitis

Interventions

Type	Name	Description
BIOLOGICAL	Infliximab	5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
DRUG	Cyclophosphamide	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).
DRUG	Prednisolone	Daily oral 1mg/kg tapered over 12 months
DRUG	Azathioprine	Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
PROCEDURE	Plasma exchange	Additional therapy for patients with severe vasculitis (creatinine \> 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
DRUG	Mycophenolate mofetil	Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
DRUG	Methylprednisolone	500 mg intravenous infusion daily for three days at lead physicians discretion.

Timeline

• Start date: 2003-01-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-09-16
• Last updated: 2008-09-16

Locations

1 site across 1 country: United Kingdom