Tocilizumab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Not Applicable
- Conditions
- ANCA-associated vasculitis
- Registration Number
- JPRN-UMIN000002892
- Lead Sponsor
- Research Committee of multicentre clinical trials for intractable ANCA-associated vasculitis of the Ministry of Health, Labor and Welfare of Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method remission induction
- Secondary Outcome Measures
Name Time Method adverse events, BVAS VDI, SF-36