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)
IRB Number: 2015-090
April 15, 2019
Institutional Review Board, Hospital for Special Surgery
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Principal Investigator
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