37
Participants
Start Date
January 31, 2003
Primary Completion Date
July 31, 2006
Study Completion Date
July 31, 2006
Infliximab
5 mg/kg intravenous infusion at weeks 0, 2, 6 and 10 of study
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).
Prednisolone
Daily oral 1mg/kg tapered over 12 months
Azathioprine
Daily oral 2 mg/kg started once patient is in remission and cyclophosphamide has been discontinued.
Plasma exchange
Additional therapy for patients with severe vasculitis (creatinine \> 500 mcmol/L or pulmonary haemorrhage). 7x 4L exchanges over 10 days.
Mycophenolate mofetil
Daily oral up to 1.5 g twice daily as tolerated. Used as alternative to azathioprine at lead physicians discretion.
Methylprednisolone
500 mg intravenous infusion daily for three days at lead physicians discretion.
University Hospitals Birmingham NHS Foundation Trust, Birmingham
University Hospital Birmingham NHS Foundation Trust
OTHER