A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus (VOYAGER)
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.
Lupus Erythematosus, Systemic
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Percentage of Participants With at Least 1 Serious Adverse Event [ Time Frame: Baseline to the end of the study (up to 52 weeks) ] [ Designated as safety issue: No ]A serious adverse event is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator.
|Study Start Date:||June 2006|
|Study Completion Date:||February 2012|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Rituximab 1000 mg
Participants will receive rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants will also receive methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Rituximab will be supplied as a liquid for intravenous infusion.Drug: Methylprednisolone Drug: Acetaminophen Drug: Diphenhydramine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381810
|Study Director:||Paul Brunetta, M.D.||Genentech, Inc.|