Research

A Phase 2B, Dose Ranging Study to Evaluate the Efficacy and Safety of Sifalimumab in Adults with SLE

IRB Number: 11113

Institutional Review Board, Hospital for Special Surgery

October 12, 2011

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, DSc, FACP

Co-Investigators

Nancy Pan, MD

Summary

There is a need for new effective treatments for lupus.  Therefore the main goal of this study is to see whether the addition of sifalimumab to your current lupus treatment is effective in reducing the signs (such as skin lesions, arthritis) and symptoms (such as fatigue) of lupus in subjects with moderate to severe disease.  This study is also testing whether the addition of sifalimumab can improve control of your disease to the point that the dose of any cortisone-like medicines you were on at the start of the study can be reduced. 
The subjects in this study will be adult men and women, aged 18 to 75 years old, with chronic moderately-to-severely active lupus and who require therapy in addition to their standard-of-care treatment.
While you are in the study, you will receive the study drug every 14 days for the first 3 doses, and then every 28 days until Day 337 (day of last dose).  The study drug will be given to you in your vein and will take between 60 and 90 minutes to administer.  This is called an intravenous or IV infusion.

Women who are pregnant or nursing a child may not participate in this study.  There may be other reasons why you cannot participate in this research study.  Your study doctor or study staff will discuss these with you.

Inclusion/Exclusion Criteria

Patients with mildly active lupus will be considered.

Contact Information

Margaret Robotham robathamm@hss.edu 212.774.2967

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