A Phase II Randomized Double- Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Rontalizumab (rhuMAb IFNalpha) In Patients with Moderately to Severely Active SLE.

Institutional Review Board, Hospital for Special Surgery

February 05, 2010

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

Kyriakos A. Kirou, MD

Co-Investigators

Stephen J. Di Martino, MD      
Julie Cherian, MD

Summary

The experimental drug is called Rontalizumab or rhuMAb interferon alpha.
The purpose of this study is to investigate the safety and the effects of rontalizumab for the treatment of SLE in adults with SLE. 
Approximately 210 subjects will take part in this study at about 100 study centers in the United States and other countries in the rest of the world.
This is an approximately 72-week study that includes up to 3 phases:  up to 28 days screening, 24-week study drug period, and 48-week follow-up period. 
In Part 1, approximately 1 study visit is required for the screening, 8 visits for the study drug period, and 6 visits during the follow-up period. 
In Part 2, approximately 1 study visit is required during the screening, 13 visits during the study drug period, and 6 visits during the follow-up period of this study.

Inclusion/Exclusion Criteria

Patients with moderately to severely active SLE.

Contact Information

Roland Duculan
duculanr@hss.edu
212.774. 2967