A Randomized, Double Blind, Placebo Controlled, Multicenter Prospective Dose Finding Phase II/III Study with Atacicept Given Subcutaneously to Subjects having Recently Experienced a Flare of SLE3

 

IRB Number: 28053

Institutional Review Board, Hospital for Special Surgery

January 13, 2009

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.

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Principal Investigator

Michael D. Lockshin, MD

Co-Investigators

Doruk Erkan, M.D.

Summary

A Randomized, Double Blind, Placebo Controlled, Multicenter Prospective Dose Finding Phase II/III Study with Atacicept Given Subcutaneously to Subjects having Recently Experienced a Flare of SLE3. 

Inclusion/Exclusion Criteria

Inclusion criteria: diagnosis of SLE and active SLE at initial screening, patients older than 16 years of age.

Contact Information

JoAnn Vega
212.774.2795
vegaj@hss.edu

Vidhi Tyagi
212.774.2808
tyagiv@hss.edu