A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Phase 2 Completed 283 enrolled Human Genome Sciences Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).

Timeline

Start: 2003-12
Primary completion: 2005-01
Completion: 2005-12

Publications

Stohl W, Merrill JT, McKay JD, Lisse JR, Zhong ZJ, Freimuth WW, Genovese MC. Efficacy and safety of belimumab in patients with rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled, dose-ranging Study. J Rheumatol. 2013 May;40(5):579-89. doi: 10.3899/jrheum.120886. Epub 2013 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Belimumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Belimumab	Monoclonal antibody	4 mg/kg	Intravenous
Subject	Belimumab	Monoclonal antibody	10 mg/kg	Intravenous

A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

Summary

Timeline

Publications

Drugs

Indications