A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated with or without BENLYSTA™ (belimumab)

Institutional Review Board, Hospital for Special Surgery

April 15, 2019

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

Doruk Erkan, MD, MPH

Summary

This is a multi-center, prospective, observational cohort study to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in patients with active, autoantibody-positive SLE treated with and without BENLYSTA.

• The study will enroll approximately 3,000 patients, approximately 2,000 in the
BENLYSTA cohort and 1,000 in the comparison cohort. 

• Enrollment has been extended to January 2020
• Data will be collected at enrollment and at 6 month intervals for 5 years (60 months).

Inclusion/Exclusion Criteria

Inclusion: 

• Males or females age 18 or older.
• Have a clinical diagnosis of active SLE.
• Current or history of autoantibody-positive SLE.
• Must be treated with SLE therapy including Benlysta and/or immunosuppressants (eg, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).
• Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.

Exclusion:

• Treatment with an investigational drug within one year of enrollment;  Investigational drug applies to any drug not approved for sale in the country it is being used.
• Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent.
• Patients who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
• Patients only receiving an anti-malarial for SLE.
• Patients only receiving steroids for SLE.

Contact Information

JoAnn Vega, CCRC
vegaj@hss.edu
212.774.2795