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

Phase 3 Terminated 31 enrolled Genentech, Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2006-06-22
Primary completion: 2008-07-31
Completion: 2012-02-29

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	1000 mg	Intravenous
Background	Acetaminophen	Small molecule	1000 mg	Oral
Background	Diphenhydramine	Unknown	50 mg	Oral
Background	Methylprednisolone	Other / unclassified	100 mg	Intravenous
Background	Methylprednisolone	Other / unclassified	125 mg	Intravenous

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

Summary

Timeline

Drugs

Indications