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

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.

Timeline

Start

2005-05-10

Primary completion

2008-08-25

Completion

2008-08-25

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Rituximab 1000 mg + Prednisone vs Placebo + Prednisone; p = 0.4875; Wilcoxon (Mann-Whitney); note: One-sided p-value. NCT00137969 ↗

paper No differences were observed between placebo and rituximab in the primary and secondary efficacy end points PMID 20039413 ↗

Publications

• Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	1000 mg	Intravenous
Background	Acetaminophen	Small molecule	1000 mg	Oral
Background	Diphenhydramine	Small molecule	50 mg	Oral
Background	Prednisone	Other / unclassified	10 mg	Oral

Indications