UMIN ID: UMIN000000906
Registered date:01/12/2007
Rituximab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | ANCA-associated vasculitis |
| Date of first enrollment | 2006/04/01 |
| Target sample size | 15 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Weekly infusion of Rituximab 375mg per square meter for 4 times plus oral daily prednisolone 0.5-1mg/kg for 2 weeks and tapered. |
Outcome(s)
| Primary Outcome | complete remission at 12 months |
|---|---|
| Secondary Outcome | adverse events, BVAS/WG, VDI |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. severe infection (including tuberculosis, HCV, HBV and HIV). 2. history of hypersensitivity to mouse-derived protein 3. congestive heart failure with NYHA III or IV |
Related Information
| Primary Sponsor | Research Comittee of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | the Ministry of Health, Labor and Welfare of Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| office.mhlw.vasculitis-res@marianna-u.ac.jp | |
| Affiliation | St. Marianna University School of Medicine Division of Rheumatology and Allergy |
| scientific contact | |
| Name | Shoichi Ozaki |
| Address | 2-16-1 Sugao, Miyamae-ku, Kawasaki Japan |
| Telephone | 044-977-8111 |
| Affiliation | St. Marianna University School of Medicine Division of Rheumatology and Allergy |