Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry

Status:	Recruiting
Conditions:	Lupus
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	7/18/2018
Start Date:	February 21, 2013
End Date:	January 31, 2025
Contact:	US GSK Clinical Trials Call Center
Email:	GSKClinicalSupportHD@gsk.com
Phone:	877-379-3718

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)

The purpose of this registry is to collect additional information regarding the side effects
and effectiveness of BENLYSTA (belimumab) when given with other lupus medicines to adults
with active systemic lupus erythematosus (SLE). Information will be collected on serious
events that are not that common or may only be seen with long-term treatment. These events
include death, cancers, serious infections and other infections of interest, and serious
mental health problems. Information on the effectiveness of BENLYSTA will also be collected.

The registry will enroll 2 groups of patients. One group will include patients who are
currently taking lupus medicines along with BENLYSTA (With BENLYSTA). The other group will
include patients who are taking lupus medicines but do not take BENLYSTA (Without BENLYSTA).
For every 3 participants enrolled in the registry, 2 will be taking BENLYSTA and 1 will not.
After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are
at the discretion of the physician, and all patients will continue to be followed regardless
of changes in their lupus medicines until study completion. Physicians will manage the
patient in accordance with their medical judgment and standard of care. Data will be
collected at enrollment and at 6 month intervals for 5 years.

Key Inclusion Criteria:

- Clinical diagnosis of active SLE.

- Autoantibody-positive.

- Current SLE treatment includes BENLYSTA and/or immunosuppressants (for example,
azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).

Key Exclusion Criteria:

- Have received treatment with an investigational agent within the past year.

- Are currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or
a continuation trial in which belimumab is used as an investigational agent.

- Have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.

- Current SLE treatment includes only an antimalarial (for example, hydroxychloroquine)
or only steroids.

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Safety and Effectiveness of Belimumab in Systemic Lupus Erythematosus Registry

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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)

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