January 16, 2008

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled 76 Week Study to Evaluate the Efficacy and Safety of Belimumab (GHS1006, LymphoStat-B), A fully Human monoclonal Anti-BlyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE).

IRB Number: 27076

Institutional Review Board
Hospital for Special Surgery

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Michael D. Lockshin, M.D.

Co-Investigators

Doruk Erkan, M.D.

Summary

To evaluate the efficacy, safety and tolerability of belimumab in subjects with SLE.  To evaluate the impact of belimumab on quality of life in subjects with SLE.   Six patients will be enrolled and followed for a year and a half.

Inclusion/Exclusion Criteria

Inclusion/Exclusion Criteria:  Patients must have active lupus despite treatment at the time of enrollment.

Contact Information

JoAnn Vega
Study Coordinator
212.774.2795
vegaj@hss.edu

Vidhi Tyagi
Study Coordinator
tyagiv@hss.edu
212.774.2808