Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry (SABLE)

February 27, 2026 updated by: GlaxoSmithKline

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 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.

Study Overview

Status

Completed

Conditions

Systemic Lupus Erythematosus

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1280AEB
    - GSK Investigational Site
  - Ciudad autOnoma de Bueno, Argentina, C1426AAL
    - GSK Investigational Site
  - Paraná, Argentina, 3103
    - GSK Investigational Site
Austria
- - Graz, Austria, 8036
    - GSK Investigational Site
  - Linz, Austria, 4021
    - GSK Investigational Site
  - Salzburg, Austria, A-5020
    - GSK Investigational Site
  - Vienna, Austria, A-1100
    - GSK Investigational Site
Belgium
- - Leuven, Belgium, 3000
    - GSK Investigational Site
Canada
- Ontario
  - Mississauga, Ontario, Canada, L5M 2V8
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5T 2S8
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H3G 1A4
    - GSK Investigational Site
  - Québec, Quebec, Canada, G1V 2L9
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1G 2E8
    - GSK Investigational Site
France
- - Bondy, France, 93140
    - GSK Investigational Site
  - Lille, France, 59037
    - GSK Investigational Site
  - Paris, France, 75571
    - GSK Investigational Site
  - Strasbourg, France, 67098
    - GSK Investigational Site
Germany
- - Bad Bramstedt, Germany, 24576
    - GSK Investigational Site
  - Bad Nauheim, Germany, 61231
    - GSK Investigational Site
  - Cologne, Germany, 51149
    - GSK Investigational Site
  - Dresden, Germany, 01067
    - GSK Investigational Site
  - Düsseldorf, Germany, 40225
    - GSK Investigational Site
  - Elmshorn, Germany, 25335
    - GSK Investigational Site
  - Halle, Germany, 06120
    - GSK Investigational Site
  - Hamburg, Germany, 22767
    - GSK Investigational Site
  - Heidelberg, Germany, 69121
    - GSK Investigational Site
  - Jena, Germany, 07740
    - GSK Investigational Site
  - Kiel, Germany, 24105
    - GSK Investigational Site
  - Kiel, Germany, 23538
    - GSK Investigational Site
  - Leipzig, Germany, 04129
    - GSK Investigational Site
  - Mainz, Germany, 55131
    - GSK Investigational Site
  - Püttlingen, Germany, 66346
    - GSK Investigational Site
  - Stuttgart, Germany, 70376
    - GSK Investigational Site
Israel
- - Ashkelon, Israel, 78278
    - GSK Investigational Site
  - Haifa, Israel, 31096
    - GSK Investigational Site
  - Haifa, Israel, 31048
    - GSK Investigational Site
  - Jerusalem, Israel, 91120
    - GSK Investigational Site
  - Nahariya, Israel, 22100
    - GSK Investigational Site
  - Petah Tikva, Israel, 49100
    - GSK Investigational Site
  - Ramat Gan, Israel, 52621
    - GSK Investigational Site
  - Rehovot, Israel, 76100
    - GSK Investigational Site
  - Tel Aviv, Israel, 64239
    - GSK Investigational Site
Italy
- - Brescia, Italy, 25125
    - GSK Investigational Site
  - Milan, Italy, 20132
    - GSK Investigational Site
  - Milan, Italy, 20122
    - GSK Investigational Site
  - Milan, Italy, 20157
    - GSK Investigational Site
  - Padua, Italy, 35128
    - GSK Investigational Site
  - Pisa, Italy, 56126
    - GSK Investigational Site
  - Roma, Italy, 00168
    - GSK Investigational Site
  - Roma, Italy, 00161
    - GSK Investigational Site
  - Siena, Italy, 53100
    - GSK Investigational Site
  - Udine, Italy, 33100
    - GSK Investigational Site
Portugal
- - Lisbon, Portugal, 1069-166
    - GSK Investigational Site
Slovakia
- - Bratislava, Slovakia, 826 06
    - GSK Investigational Site
  - Košice, Slovakia, 040 11
    - GSK Investigational Site
  - Košice, Slovakia, 97401
    - GSK Investigational Site
  - Piešťany, Slovakia, 921 01
    - GSK Investigational Site
  - Piešťany, Slovakia, 921 12
    - GSK Investigational Site
Spain
- - A Coruña, Spain, 15006
    - GSK Investigational Site
  - Alicante, Spain, 03010
    - GSK Investigational Site
  - BaracaldoVizcaya, Spain, 48903
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08907
    - GSK Investigational Site
  - Getafe, Spain, 28905
    - GSK Investigational Site
  - Las Palmas, Spain, 35020
    - GSK Investigational Site
  - Madrid, Spain, 28041
    - GSK Investigational Site
  - Madrid, Spain, 28007
    - GSK Investigational Site
  - Madrid, Spain, 28222
    - GSK Investigational Site
  - Murcia, Spain, 30120
    - GSK Investigational Site
  - Santander, Spain, 39008
    - GSK Investigational Site
  - Toledo, Spain, 45111
    - GSK Investigational Site
  - Valencia, Spain, 46017
    - GSK Investigational Site
  - Valencia, Spain, 46026
    - GSK Investigational Site
  - Valladolid, Spain, 47012
    - GSK Investigational Site
  - VigoPontevedra, Spain, 36200
    - GSK Investigational Site
  - Villajoyosa, Spain, 3570
    - GSK Investigational Site
Sweden
- - Stockholm, Sweden, SE-171 76
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - GSK Investigational Site
- Arizona
  - Glendale, Arizona, United States, 85304
    - GSK Investigational Site
  - Goodyear, Arizona, United States, 85395
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85032
    - GSK Investigational Site
  - Phoenix, Arizona, United States, 85037
    - GSK Investigational Site
  - Prescott, Arizona, United States, 86305
    - GSK Investigational Site
  - Sun City, Arizona, United States, 85351
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85712
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85704
    - GSK Investigational Site
- California
  - Bakersfield, California, United States, 93301
    - GSK Investigational Site
  - La Mesa, California, United States, 92020
    - GSK Investigational Site
  - Lakewood, California, United States, 90712
    - GSK Investigational Site
  - Loma Linda, California, United States, 92354
    - GSK Investigational Site
  - Los Angeles, California, United States, 90095
    - GSK Investigational Site
  - Los Angeles, California, United States, 90048
    - GSK Investigational Site
  - Los Angeles, California, United States, 90033
    - GSK Investigational Site
  - Murrieta, California, United States, 92563
    - GSK Investigational Site
  - Pomona, California, United States, 91767
    - GSK Investigational Site
  - Upland, California, United States, 91786
    - GSK Investigational Site
  - West Hills, California, United States, 91307
    - GSK Investigational Site
- Connecticut
  - Danbury, Connecticut, United States, 06810
    - GSK Investigational Site
  - New Haven, Connecticut, United States, 06520
    - GSK Investigational Site
  - Orangeburg, Connecticut, United States, 06518
    - GSK Investigational Site
- Florida
  - Brandon, Florida, United States, 33511
    - GSK Investigational Site
  - Clearwater, Florida, United States, 33759
    - GSK Investigational Site
  - Fort Lauderdale, Florida, United States, 33309
    - GSK Investigational Site
  - Jupiter, Florida, United States, 33458
    - GSK Investigational Site
  - Largo, Florida, United States, 33770
    - GSK Investigational Site
  - Miami, Florida, United States, 33136
    - GSK Investigational Site
  - Miami, Florida, United States, 33126
    - GSK Investigational Site
  - Palm Harbor, Florida, United States, 34684
    - GSK Investigational Site
  - Pembroke Pines, Florida, United States, 33026
    - GSK Investigational Site
  - Pensacola, Florida, United States, 32514
    - GSK Investigational Site
  - Plantation, Florida, United States, 33324
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30303
    - GSK Investigational Site
  - Gainesville, Georgia, United States, 30501
    - GSK Investigational Site
- Idaho
  - Meridian, Idaho, United States, 83642
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - GSK Investigational Site
  - Chicago, Illinois, United States, 60612
    - GSK Investigational Site
  - Morton Grove, Illinois, United States, 60053
    - GSK Investigational Site
- Indiana
  - South Bend, Indiana, United States, 46601
    - GSK Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 71103
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21286
    - GSK Investigational Site
- Massachusetts
  - Springfield, Massachusetts, United States, 01107
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109-5542
    - GSK Investigational Site
  - Ann Arbor, Michigan, United States, 48917
    - GSK Investigational Site
  - Detroit, Michigan, United States, 48202
    - GSK Investigational Site
- Minnesota
  - Eagan, Minnesota, United States, 55121
    - GSK Investigational Site
  - Edina, Minnesota, United States, 55435
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - GSK Investigational Site
  - Tupelo, Mississippi, United States, 38801
    - GSK Investigational Site
- Missouri
  - St Louis, Missouri, United States, 63110
    - GSK Investigational Site
  - St Louis, Missouri, United States, 63117
    - GSK Investigational Site
  - St Louis, Missouri, United States, 63132
    - GSK Investigational Site
- Nebraska
  - Omaha, Nebraska, United States, 68198-7680
    - GSK Investigational Site
- Nevada
  - Henderson, Nevada, United States, 89052
    - GSK Investigational Site
- New Jersey
  - Summit, New Jersey, United States, 07901
    - GSK Investigational Site
  - Teaneck, New Jersey, United States, 07666
    - GSK Investigational Site
  - Voorhees Township, New Jersey, United States, 08103
    - GSK Investigational Site
- New York
  - Manhasset, New York, United States, 11030
    - GSK Investigational Site
  - Mineola, New York, United States, 11501
    - GSK Investigational Site
  - New York, New York, United States, 10021
    - GSK Investigational Site
  - New York, New York, United States, 10016
    - GSK Investigational Site
  - Roslyn, New York, United States, 11576
    - GSK Investigational Site
  - Smithtown, New York, United States, 11787
    - GSK Investigational Site
  - The Bronx, New York, United States, 10461
    - GSK Investigational Site
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - GSK Investigational Site
  - Charlotte, North Carolina, United States, 28204
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27405
    - GSK Investigational Site
  - New Bern, North Carolina, United States, 28562
    - GSK Investigational Site
  - Raleigh, North Carolina, United States, 27617
    - GSK Investigational Site
  - Rocky Mount, North Carolina, United States, 27804
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27157
    - GSK Investigational Site
- Ohio
  - Columbus, Ohio, United States, 43203
    - GSK Investigational Site
  - Toledo, Ohio, United States, 43614
    - GSK Investigational Site
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Oklahoma City, Oklahoma, United States, 73104
    - GSK Investigational Site
  - Oklahoma City6, Oklahoma, United States, 73103
    - GSK Investigational Site
  - Tulsa, Oklahoma, United States, 74104
    - GSK Investigational Site
- Pennsylvania
  - Duncansville, Pennsylvania, United States, 16635
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19107
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15224
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - GSK Investigational Site
  - Charleston, South Carolina, United States, 29406
    - GSK Investigational Site
- Tennessee
  - Hixson, Tennessee, United States, 37343-7908
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37203
    - GSK Investigational Site
- Texas
  - Allen, Texas, United States, 75013
    - GSK Investigational Site
  - Arlington, Texas, United States, 22205-3606
    - GSK Investigational Site
  - Houston, Texas, United States, 77004
    - GSK Investigational Site
  - Houston, Texas, United States, 77034
    - GSK Investigational Site
  - Nassau Bay, Texas, United States, 77058
    - GSK Investigational Site
  - Round Rock, Texas, United States, 78665
    - GSK Investigational Site
  - San Marcos, Texas, United States, 78666
    - GSK Investigational Site
  - The Woodlands, Texas, United States, 77382
    - GSK Investigational Site
- Virginia
  - Danville, Virginia, United States, 24541
    - GSK Investigational Site
  - Norfolk, Virginia, United States, 23502
    - GSK Investigational Site
  - Roanoke, Virginia, United States, 24016
    - GSK Investigational Site
- Washington
  - Seattle, Washington, United States, 98133
    - GSK Investigational Site
- Wisconsin
  - Glendale, Wisconsin, United States, 91204
    - GSK Investigational Site
  - Manitowoc, Wisconsin, United States, 54221-1450
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants with active autoantibody-positive SLE.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Benlysta Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to [>=2] months at enrollment) of Benlysta.	Biological: Benlysta As prescribed. Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus. Other Names: belimumab Other: Standard of Care (SoC) Therapy As prescribed. At baseline, SoC therapy must have included an immunosuppressant. During the registry, SoC therapy could include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.
Non-Benlysta Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy.	Other: Standard of Care (SoC) Therapy As prescribed. At baseline, SoC therapy must have included an immunosuppressant. During the registry, SoC therapy could include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Group / Cohort

Intervention / Treatment

Benlysta

Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to [>=2] months at enrollment) of Benlysta.

Biological: Benlysta

As prescribed.

Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.

Other Names:

belimumab

Other: Standard of Care (SoC) Therapy

As prescribed.

At baseline, SoC therapy must have included an immunosuppressant. During the registry, SoC therapy could include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Non-Benlysta

Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for >=2 months at enrollment) of SoC therapy.

Other: Standard of Care (SoC) Therapy

As prescribed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy Time Frame: Up to 63 Months	An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs included mortality, malignancies (excluding non-melanoma skin cancers [NMSC]), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events. Initial exposure ITT strategy assigned exposure status of participants based on SLE medication (Benlysta or Non-Benlysta) at enrollment (Day 0). This exposure strategy analyzed all accrued AESI data during the whole follow-up period irrespective of treatment switching from Benlysta to Non-Benlysta or vice-versa.	Up to 63 Months
Incidence Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 12 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events divided by (/) Total participant-years at risk of event expressed per 100 participant-years.	Up to 12 Months
Incidence Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 24 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 24 Months
Incidence Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 36 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 36 Months
Incidence Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 48 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 48 Months
Incidence Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 63 Months	An AE is defined as any unfavorable or unintended sign, symptom, or disease that is temporally associated with the use of a study agent but is not necessarily caused by the study agent. AESIs including mortality, malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. Hence, a participant's exposure group could change over time depending on the SLE medication in use at specific time during study follow-up. For Benlysta, a 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Incidence rate is calculated as: Number of first events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 63 Months
Event Rate of AESI Up to 12 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 12 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 12 Months
Event Rate of AESI Up to 24 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 24 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 24 Months
Event Rate of AESI Up to 36 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 36 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 36 Months
Event Rate of AESI Up to 48 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 48 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 48 Months
Event Rate of AESI Up to 63 Months Using As-Exposed - Time Varying Strategy Time Frame: Up to 63 Months	An AE is any unfavorable or unintended sign, symptom, or disease that is temporally associated with use of study agent but is not necessarily caused by study agent. AESIs including malignancies (excluding NMSC), serious infections, opportunistic infections and other infections of interest, NMSC, and selected serious psychiatric events were summarized. As event rate was computed for potentially recurrent events, no event rate was computed for mortality. As-exposed (time varying) exposure strategy dynamically assigned participants' exposure group based on Benlysta/Non-Benlysta use at time of event, during study follow-up. So, a participant's exposure group could change over time depending on SLE medication in use at specific time during study follow-up. For Benlysta, 14-week risk window was applied wherein exposure ended 14 weeks after Benlysta stopped. Event rate is calculated as: Number of all events / Total participant-years at risk of event expressed per 100 participant-years.	Up to 63 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with organ damage Time Frame: Up to 5 years	Organ damage will be assessed by System Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI). It is designed to capture items of irreversible organ damage present for at least 6 months occurring in participants with SLE regardless of exact cause. It consists of 12 organ system scales each having subscales which comprises of up to 6 components.	Up to 5 years
Number of participants with use of concomitant SLE medications Time Frame: Up to 5 years	Concomitant SLE medications including steroids are the medications used to treat SLE (immunosuppressants, anti-malarials, corticosteroids, biologics, and investigational agents for SLE).	Up to 5 years
Number of participants with hospitalizations Time Frame: Up to 5 years	An inpatient hospitalization is defined as an admission for greater than 24 hours. An admission for administration of medication or for routine or planned clinical procedures will not be considered a hospitalization. Dates of hospital admission and discharge, and whether the hospitalization was SLE-related will be collected, as available.	Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2013

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

February 28, 2025

Study Registration Dates

First Submitted

November 14, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimated)

November 20, 2012

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

February 27, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

116543
HGS1006-C1124 (Other Identifier: Human Genome Sciences Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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