for people ages 18 years and up (full criteria)
at Los Angeles, California and other locations
study started
completion around



The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

Official Title

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)


Systemic Lupus Erythematosus, Belimumab, BENLYSTA, Autoimmune Disease, Autoantibodies, SLE treatment


You can join if…

Open to people ages 18 years and up

  • Males or females age 18 years 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 (for example, 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.

You CAN'T join if...

  • 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.
  • Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
  • Participants only receiving an anti-malarial for SLE.
  • Participants only receiving steroids for SLE.


  • GSK Investigational Site
    Los Angeles California 90095 United States
  • GSK Investigational Site
    Los Angeles California 90048 United States
  • GSK Investigational Site
    Glendale California 91204 United States
  • GSK Investigational Site
    Los Angeles California 90033 United States
  • GSK Investigational Site
    West Hills California 91307 United States
  • GSK Investigational Site
    Lakewood California 90712 United States


in progress, not accepting new patients
Start Date
Completion Date
Study Type
Observational [Patient Registry]
About 3138 people participating
Last Updated