Clinical Trial: A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of Rituximab in Subjects With Moderate to Severe Systemic Lupus<

Brief 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.

Detailed Summary:
Sponsor: Genentech, Inc.

Current Primary Outcome: Percentage of Participants With at Least 1 Serious Adverse Event [ Time Frame: Baseline to the end of the study (up to 52 weeks) ]

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.


Original Primary Outcome: To assess the efficacy of rituximab compared with placebo in achieving and maintaining a major clinical response or partial clinical response in subjects with moderate to severe systemic lupus erythematosus.

Current Secondary Outcome:

Original Secondary Outcome: To evaluate the ability of rituximab to decrease overall SLE disease activity, to prolong the time to a moderate or severe flare, to improve quality of life, and to achieve a BILAG C or better at Week 24.

Information By: Genentech, Inc.

Dates:
Date Received: August 26, 2005
Date Started: May 2005
Date Completion:
Last Updated: March 24, 2015
Last Verified: March 2015