Anti-Cytokine Therapy for Vasculitis
- Conditions
- Wegener's GranulomatosisRenal Limited VasculitisMicroscopic Polyangiitis
- Interventions
- Biological: InfliximabProcedure: Plasma exchange
- Registration Number
- NCT00753103
- Lead Sponsor
- University Hospital Birmingham NHS Foundation Trust
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
- Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)
- Active infection
- Malignancy
- Pregnancy
- Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Infliximab Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy 1 Azathioprine Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy 1 Mycophenolate mofetil Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy 2 Plasma exchange Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab 1 Cyclophosphamide Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy 1 Prednisolone Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy 2 Cyclophosphamide Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab 2 Prednisolone Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab 2 Mycophenolate mofetil Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab 2 Azathioprine Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab 1 Methylprednisolone Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy 2 Methylprednisolone Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab
- Primary Outcome Measures
Name Time Method Time to clinical remission (Birmingham Vasculitis Activity Score 0 or 1) 0, 6, 10, 14, 26, 39 and 52 weeks
- Secondary Outcome Measures
Name Time Method Adverse events Weeks 2, 6, 10, 14, 26, 39, 52 Vasculitis Damage Index Score Weeks 0, 14, 26, 39, 52 Renal function Weeks 0, 2, 6, 10, 14, 26, 39, 52
Trial Locations
- Locations (1)
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, West Midlands, United Kingdom