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 received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
Rituximab was 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.|