Research

EXPLORER: A 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

IRB Number: 25058

Institutional Review Board, Hospital for Special Surgery

May 17, 2006

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, MD

Co-Investigators

Doruk Erkan, MD

Summary

The purpose of this study is to assess the efficacy of rituximab compared with placebo for the treatment of patients with active systemic lupus erythematosus (SLE).  This is a multi-center trial in which patients will be followed for 18 months.

Inclusion/Exclusion Criteria

Patient must have active SLE despite treatment at the time of enrollment.

Contact Information

JoAnn Vega
212.774.2795
vegaj@hss.edu



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