Last updated: 02/26/2026 14:30:09
Safety and effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) RegistrySABLE
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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)
Trial description: 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.
Primary purpose:
Other
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy
Timeframe: Up to 63 Months
Incidence Rate of AESI Up to 12 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 12 Months
Incidence Rate of AESI Up to 24 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 24 Months
Incidence Rate of AESI Up to 36 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 36 Months
Incidence Rate of AESI Up to 48 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 48 Months
Incidence Rate of AESI Up to 63 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 63 Months
Event Rate of AESI Up to 12 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 12 Months
Event Rate of AESI Up to 24 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 24 Months
Event Rate of AESI Up to 36 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 36 Months
Event Rate of AESI Up to 48 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 48 Months
Event Rate of AESI Up to 63 Months Using As-Exposed – Time Varying Strategy
Timeframe: Up to 63 Months
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Benlysta
Other: Standard of Care (SoC) Therapy
Enrollment:
3138
Observational study model:
Cohort
Primary completion date:
2025-28-02
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
February 2013 to February 2025
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Males or females age 18 years or older.
- Have a clinical diagnosis of active SLE.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Trial location(s)
Location
GSK Investigational Site
Ann Arbor, MI, United States, 48109-5542
Status
Study Complete
Location
GSK Investigational Site
Arlington, TX, United States, 22205-3606
Status
Study Complete
Location
GSK Investigational Site
Ciudad autOnoma de Bueno, Argentina, C1426AAL
Status
Study Complete
Location
GSK Investigational Site
Duncansville, PA, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, FL, United States, 33309
Status
Study Complete
Location
GSK Investigational Site
Manitowoc, WI, United States, 54221-1450
Status
Study Complete
Location
GSK Investigational Site
Morton Grove, IL, United States, 60053
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, OK, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, OK, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City6, OK, United States, 73103
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, FL, United States, 33026
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, PA, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
The Woodlands, TX, United States, 77382
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, NC, United States, 27157
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2025-28-02
Actual study completion date
2025-28-02
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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