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Phase II study of Rituximab in Patients with Systemic Lupus Erythematosus

Phase II study of Rituximab in Patients with Systemic Lupus Erythematosus - Compassionate open study of Rituximab in Systemic lupus Erythematosus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000762
Enrollment
70
Registered
2007-07-05
Start date
2007-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Interventions

1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).

Sponsors

Zenyaku Kogyo Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients who perticipated in the II/III study (Protocol No.IDEC-C2B8-A3) and were allocated to placebo group. 2.Under 80 years of age at the time of signing an informed consent form etc.

Exclusion criteria

Exclusion criteria: 1)Proteinuria>1.0g/24hr 2)APS complication 3)Pregnant women or lactating mothers 4)Positive HIV, HCV, HBs, HBc etc.

Design outcomes

Primary

MeasureTime frame
Efficacy evaluation

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026