Anti-Cytokine Therapy for Vasculitis

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

January 31, 2003

Primary Completion Date

July 31, 2006

Study Completion Date

July 31, 2006

Conditions
Wegener's GranulomatosisRenal Limited VasculitisMicroscopic Polyangiitis
Interventions
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.

Trial Locations (1)

B15 2TT

University Hospitals Birmingham NHS Foundation Trust, Birmingham

All Listed Sponsors
lead

University Hospital Birmingham NHS Foundation Trust

OTHER

NCT00753103 - Anti-Cytokine Therapy for Vasculitis | Biotech Hunter | Biotech Hunter