Trials / Terminated
TerminatedNCT00381810
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
An Open-label, Single-arm, Multicenter Phase II/III Extension Study to Evaluate the Safety of Rituximab Re-treatment in Subjects With Moderate to Severe Systemic Lupus Erythematosus Previously Enrolled in Protocol U2971g
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 16 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase II/III open label, single-arm, multicenter, extension study to evaluate the safety and efficacy of rituximab when administered on a scheduled basis every 6 months over the course of 1 year with reassessment of response at 12 months. This study is open to participants previously enrolled in Genentech Study U2971g only.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab | Rituximab will be supplied as a liquid for intravenous infusion. |
| DRUG | Methylprednisolone | |
| DRUG | Acetaminophen | |
| DRUG | Diphenhydramine |
Timeline
- Start date
- 2006-06-22
- Primary completion
- 2008-07-31
- Completion
- 2012-02-29
- First posted
- 2006-09-28
- Last updated
- 2017-08-01
- Results posted
- 2009-12-18
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00381810. Inclusion in this directory is not an endorsement.