Anti-Cytokine Therapy for Vasculitis

Phase 2 Completed 37 enrolled University Hospital Birmingham NHS Foundation Trust

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2003-01
Primary completion: 2006-07
Completion: 2006-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Infliximab	Monoclonal antibody	5 mg/kg	Intravenous
Background	Azathioprine	Small molecule	2 mg/kg	Oral
Background	Cyclophosphamide	Other / unclassified	2 mg/kg	Oral
Background	Cyclophosphamide	Other / unclassified	15 mg/kg	Oral
Background	Methylprednisolone	Other / unclassified	500 mg	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1.5 g	Oral
Background	Prednisolone	Other / unclassified	1 mg/kg	Oral

Anti-Cytokine Therapy for Vasculitis

Summary

Timeline

Drugs

Indications