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HSS Research Institute

A Multicentre, Randomized, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterize the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

IRB Number: 2018-0567
(trial not enrolling new patients)

Institutional Review Board, Hospital for Special Surgery

January 15, 2021

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

David R. Fernandez, MD, PhD
Jeffrey Zhang-Sun

Summary

Studies have shown that Type 1 Interferons are important contributors to autoimmune diseases such as systemic lupus erythematosus. The new investigational medical treatment anifrolumab has been shown to inhibit the biological activity of Type 1 Interferons. Anifrolumab may therefore be a novel and efficacious therapy for the treatment of systemic lupus erythematosus. This clinical trial aims to assess the long-term safety and effectiveness of intravenous anifrolumab as treatment for patients with systemic lupus erythematosus.

Inclusion/Exclusion Criteria

Not necessary as study is no longer recruiting.

Contact Information

Jeffrey Zhang-Sun
zhangsunj@hss.edu
212.774.2967