UMIN ID: UMIN000000762
Registered date:05/07/2007
Phase II study of Rituximab in Patients with Systemic Lupus Erythematosus
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Systemic lupus erythematosus |
| Date of first enrollment | 2007/05/01 |
| Target sample size | 70 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183). |
Outcome(s)
| Primary Outcome | Efficacy evaluation |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Proteinuria>1.0g/24hr 2)APS complication 3)Pregnant women or lactating mothers 4)Positive HIV, HCV, HBs, HBc etc. |
Related Information
| Primary Sponsor | Zenyaku Kogyo Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Zenyaku Kogyo Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Zenyaku Kogyo Co., Ltd. License-in Product Development Section |
| scientific contact | |
| Name | Yoshiya Tanaka |
| Address | License-in Product Development Section Japan |
| Telephone | |
| Affiliation | School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine |