NCT00137969

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

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 Erythematosus

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab will be supplied as a sterile liquid for IV administration.
DRUG	Placebo	Placebo will be supplied as a sterile liquid for IV administration.
DRUG	Prednisone
DRUG	Acetaminophen
DRUG	Diphenhydramine

Timeline

• Start date: 2005-05-10
• Primary completion: 2008-08-25
• Completion: 2008-08-25
• First posted: 2005-08-30
• Last updated: 2019-08-20
• Results posted: 2010-12-10

Locations

65 sites across 2 countries: United States, Canada