ANCA-associated vasculitis
Conditions
Interventions
Infusion of Tocilizumab 8mg/kg every 2 weeks for one year.
Sponsors
Research Committee of multicentre clinical trials for intractable ANCA-associated vasculitis of the Ministry of Health, Labor and Welfare of Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Fulfill the classification criteria of either Wegener's granulomatosis or microscopic polyangiitis based on the Ministry of Health, Labor and Welfare of Japan, and satisfy one of the following criteria; 1.failed to induce remission after 6 mounths of cyclophosphamide therapy. 2.difficult to taper steroid dose after remission induction with steroid and cyclophosphamide. 3.relapsed within 1 year of remission induction therapy with cyclophosphamide. 4.difficult to repeat cyclophosphamide because of adverse reaction.
Exclusion criteria
Exclusion criteria: 1. severe infection (including tuberclosis and HIV). 2. Hepatitis B e antigen positive or Hepatitis C antibody positive. 3. Previous cyclophosphamide, (greater than 4 weeks of IV pulse cyclophosphamide regimen). 4. Previous cyclophosphamide, (greater than 2 weeks of an oral cyclophosphamide regimen). 5. WBC <3,500/microlitter. 6. platelet <100,000/microlitter. 7. lymphocytes<1,000/microlitter 8. Pregnancy or breast feeding 9. inadequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission induction | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, BVAS VDI, SF-36 | — |
Countries
Japan
Contacts
Public ContactHidehiro Yamada
St. Mariannna University school of Medicine Division of Rheumatology and Allergy
Outcome results
None listed