Anti-Cytokine Therapy for Vasculitis (ACTIVE)

University Hospital Birmingham NHS Foundation Trust

Status and phase: Completed; Phase 2

Conditions: Renal Limited Vasculitis; Wegener's Granulomatosis; Microscopic Polyangiitis

Treatments: Drug: Azathioprine; Procedure: Plasma exchange; Biological: Infliximab; Drug: Prednisolone; Drug: Mycophenolate mofetil; Drug: Cyclophosphamide; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00753103

RRK2031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Either newly diagnosed or relapsed ANCA associated vasculitis (Wegener's granulomatosis, microscopic polyangiitis, renal limited vasculitis)

Exclusion criteria

• Active infection
• Malignancy
• Pregnancy
• Diagnosis of Churg-Strauss syndrome or anti-glomerular basement membrane antibody disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

1

Experimental group

Description:

Patients with active vasculitis who receive infliximab in addition to standard immunosuppressive therapy

Treatment:

Drug: Azathioprine

Drug: Prednisolone

Drug: Mycophenolate mofetil

Drug: Cyclophosphamide

Drug: Methylprednisolone

Biological: Infliximab

2

Active Comparator group

Description:

Patients with active ANCA associated vasculitis who receive standard immunosuppression but no infliximab

Treatment:

Drug: Azathioprine

Drug: Prednisolone

Drug: Mycophenolate mofetil

Procedure: Plasma exchange

Drug: Cyclophosphamide

Drug: Methylprednisolone