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

NCT01729455 | Completed Results

• 2 other identifiers: 116543HGS1006-C1124
• Study Type: observational
• Target: 3,138
• Locations: 13 countries
• Sites: 179

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Belimumab; BENLYSTA; Systemic Lupus Erythematosus; Autoimmune Disease; Autoantibodies

Outcome Measures

Primary Outcomes (11)

• Number of Participants With Adverse Events of Special Interest (AESI) Using Initial Exposure Intent-to-Treat (ITT) Strategy

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (2)

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; Other: Standard of Care (SoC) Therapy

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

Interventions

Standard of Care (SoC) Therapy OTHER

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.

Benlysta; Non-Benlysta

Benlysta BIOLOGICAL

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

Also known as: belimumab

Benlysta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with active autoantibody-positive SLE.

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (179)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

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GSK Investigational Site

Glendale, Arizona, 85304, United States

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GSK Investigational Site

Goodyear, Arizona, 85395, United States

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GSK Investigational Site

Phoenix, Arizona, 85032, United States

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GSK Investigational Site

Phoenix, Arizona, 85037, United States

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GSK Investigational Site

Prescott, Arizona, 86305, United States

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GSK Investigational Site

Sun City, Arizona, 85351, United States

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GSK Investigational Site

Tucson, Arizona, 85704, United States

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GSK Investigational Site

Tucson, Arizona, 85712, United States

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GSK Investigational Site

Bakersfield, California, 93301, United States

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GSK Investigational Site

La Mesa, California, 92020, United States

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GSK Investigational Site

Lakewood, California, 90712, United States

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GSK Investigational Site

Loma Linda, California, 92354, United States

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GSK Investigational Site

Los Angeles, California, 90033, United States

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GSK Investigational Site

Los Angeles, California, 90048, United States

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GSK Investigational Site

Los Angeles, California, 90095, United States

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GSK Investigational Site

Murrieta, California, 92563, United States

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GSK Investigational Site

Pomona, California, 91767, United States

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GSK Investigational Site

Upland, California, 91786, United States

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GSK Investigational Site

West Hills, California, 91307, United States

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GSK Investigational Site

Danbury, Connecticut, 06810, United States

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GSK Investigational Site

New Haven, Connecticut, 06520, United States

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GSK Investigational Site

Orangeburg, Connecticut, 06518, United States

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GSK Investigational Site

Brandon, Florida, 33511, United States

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GSK Investigational Site

Clearwater, Florida, 33759, United States

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GSK Investigational Site

Fort Lauderdale, Florida, 33309, United States

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GSK Investigational Site

Jupiter, Florida, 33458, United States

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GSK Investigational Site

Largo, Florida, 33770, United States

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GSK Investigational Site

Miami, Florida, 33126, United States

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GSK Investigational Site

Miami, Florida, 33136, United States

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GSK Investigational Site

Palm Harbor, Florida, 34684, United States

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GSK Investigational Site

Pembroke Pines, Florida, 33026, United States

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GSK Investigational Site

Pensacola, Florida, 32514, United States

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GSK Investigational Site

Plantation, Florida, 33324, United States

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GSK Investigational Site

Atlanta, Georgia, 30303, United States

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GSK Investigational Site

Gainesville, Georgia, 30501, United States

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GSK Investigational Site

Meridian, Idaho, 83642, United States

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GSK Investigational Site

Chicago, Illinois, 60611, United States

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GSK Investigational Site

Chicago, Illinois, 60612, United States

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GSK Investigational Site

Morton Grove, Illinois, 60053, United States

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GSK Investigational Site

South Bend, Indiana, 46601, United States

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GSK Investigational Site

Baton Rouge, Louisiana, 70809, United States

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GSK Investigational Site

Shreveport, Louisiana, 71103, United States

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GSK Investigational Site

Baltimore, Maryland, 21286, United States

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GSK Investigational Site

Springfield, Massachusetts, 01107, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48109-5542, United States

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GSK Investigational Site

Ann Arbor, Michigan, 48917, United States

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GSK Investigational Site

Detroit, Michigan, 48202, United States

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GSK Investigational Site

Eagan, Minnesota, 55121, United States

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GSK Investigational Site

Edina, Minnesota, 55435, United States

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GSK Investigational Site

Jackson, Mississippi, 39216, United States

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GSK Investigational Site

Tupelo, Mississippi, 38801, United States

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GSK Investigational Site

St Louis, Missouri, 63110, United States

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GSK Investigational Site

St Louis, Missouri, 63117, United States

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GSK Investigational Site

St Louis, Missouri, 63132, United States

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GSK Investigational Site

Omaha, Nebraska, 68198-7680, United States

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GSK Investigational Site

Henderson, Nevada, 89052, United States

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GSK Investigational Site

Summit, New Jersey, 07901, United States

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GSK Investigational Site

Teaneck, New Jersey, 07666, United States

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GSK Investigational Site

Voorhees Township, New Jersey, 08103, United States

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GSK Investigational Site

Manhasset, New York, 11030, United States

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GSK Investigational Site

Mineola, New York, 11501, United States

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GSK Investigational Site

New York, New York, 10016, United States

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GSK Investigational Site

New York, New York, 10021, United States

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GSK Investigational Site

Roslyn, New York, 11576, United States

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GSK Investigational Site

Smithtown, New York, 11787, United States

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GSK Investigational Site

The Bronx, New York, 10461, United States

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GSK Investigational Site

Charlotte, North Carolina, 28204, United States

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GSK Investigational Site

Charlotte, North Carolina, 28207, United States

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GSK Investigational Site

Greensboro, North Carolina, 27405, United States

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GSK Investigational Site

New Bern, North Carolina, 28562, United States

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GSK Investigational Site

Raleigh, North Carolina, 27617, United States

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GSK Investigational Site

Rocky Mount, North Carolina, 27804, United States

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GSK Investigational Site

Winston-Salem, North Carolina, 27157, United States

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GSK Investigational Site

Columbus, Ohio, 43203, United States

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GSK Investigational Site

Toledo, Ohio, 43614, United States

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GSK Investigational Site

Edmond, Oklahoma, 73013, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73103, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

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GSK Investigational Site

Oklahoma City6, Oklahoma, 73103, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

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GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15224, United States

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GSK Investigational Site

Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Charleston, South Carolina, 29425, United States

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GSK Investigational Site

Hixson, Tennessee, 37343-7908, United States

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GSK Investigational Site

Nashville, Tennessee, 37203, United States

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GSK Investigational Site

Allen, Texas, 75013, United States

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GSK Investigational Site

Arlington, Texas, 22205-3606, United States

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GSK Investigational Site

Houston, Texas, 77004, United States

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GSK Investigational Site

Houston, Texas, 77034, United States

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GSK Investigational Site

Nassau Bay, Texas, 77058, United States

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GSK Investigational Site

Round Rock, Texas, 78665, United States

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GSK Investigational Site

San Marcos, Texas, 78666, United States

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GSK Investigational Site

The Woodlands, Texas, 77382, United States

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GSK Investigational Site

Danville, Virginia, 24541, United States

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GSK Investigational Site

Norfolk, Virginia, 23502, United States

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GSK Investigational Site

Roanoke, Virginia, 24016, United States

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GSK Investigational Site

Seattle, Washington, 98133, United States

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GSK Investigational Site

Glendale, Wisconsin, 91204, United States

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GSK Investigational Site

Manitowoc, Wisconsin, 54221-1450, United States

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GSK Investigational Site

Buenos Aires, C1280AEB, Argentina

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GSK Investigational Site

Ciudad autOnoma de Bueno, C1426AAL, Argentina

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GSK Investigational Site

Paraná, 3103, Argentina

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GSK Investigational Site

Graz, 8036, Austria

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GSK Investigational Site

Linz, 4021, Austria

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GSK Investigational Site

Salzburg, A-5020, Austria

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GSK Investigational Site

Vienna, A-1100, Austria

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Mississauga, Ontario, L5M 2V8, Canada

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GSK Investigational Site

Toronto, Ontario, M5T 2S8, Canada

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GSK Investigational Site

Montreal, Quebec, H3G 1A4, Canada

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GSK Investigational Site

Québec, Quebec, G1V 2L9, Canada

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GSK Investigational Site

Sherbrooke, Quebec, J1G 2E8, Canada

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GSK Investigational Site

Bondy, 93140, France

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GSK Investigational Site

Lille, 59037, France

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GSK Investigational Site

Paris, 75571, France

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GSK Investigational Site

Strasbourg, 67098, France

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GSK Investigational Site

Bad Bramstedt, 24576, Germany

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GSK Investigational Site

Bad Nauheim, 61231, Germany

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GSK Investigational Site

Cologne, 51149, Germany

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GSK Investigational Site

Dresden, 01067, Germany

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GSK Investigational Site

Düsseldorf, 40225, Germany

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GSK Investigational Site

Elmshorn, 25335, Germany

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GSK Investigational Site

Halle, 06120, Germany

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GSK Investigational Site

Hamburg, 22767, Germany

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GSK Investigational Site

Heidelberg, 69121, Germany

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GSK Investigational Site

Jena, 07740, Germany

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GSK Investigational Site

Kiel, 23538, Germany

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GSK Investigational Site

Kiel, 24105, Germany

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GSK Investigational Site

Leipzig, 04129, Germany

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GSK Investigational Site

Mainz, 55131, Germany

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GSK Investigational Site

Püttlingen, 66346, Germany

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GSK Investigational Site

Stuttgart, 70376, Germany

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GSK Investigational Site

Ashkelon, 78278, Israel

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GSK Investigational Site

Haifa, 31048, Israel

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GSK Investigational Site

Haifa, 31096, Israel

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GSK Investigational Site

Jerusalem, 91120, Israel

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GSK Investigational Site

Nahariya, 22100, Israel

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GSK Investigational Site

Petah Tikva, 49100, Israel

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GSK Investigational Site

Ramat Gan, 52621, Israel

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GSK Investigational Site

Rehovot, 76100, Israel

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GSK Investigational Site

Tel Aviv, 64239, Israel

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GSK Investigational Site

Brescia, 25125, Italy

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GSK Investigational Site

Milan, 20122, Italy

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GSK Investigational Site

Milan, 20132, Italy

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GSK Investigational Site

Milan, 20157, Italy

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GSK Investigational Site

Padua, 35128, Italy

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GSK Investigational Site

Pisa, 56126, Italy

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GSK Investigational Site

Roma, 00161, Italy

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GSK Investigational Site

Roma, 00168, Italy

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GSK Investigational Site

Siena, 53100, Italy

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GSK Investigational Site

Udine, 33100, Italy

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GSK Investigational Site

Lisbon, 1069-166, Portugal

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GSK Investigational Site

Bratislava, 826 06, Slovakia

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GSK Investigational Site

Košice, 040 11, Slovakia

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GSK Investigational Site

Košice, 97401, Slovakia

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GSK Investigational Site

Piešťany, 921 01, Slovakia

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GSK Investigational Site

Piešťany, 921 12, Slovakia

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GSK Investigational Site

A Coruña, 15006, Spain

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GSK Investigational Site

Alicante, 03010, Spain

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GSK Investigational Site

BaracaldoVizcaya, 48903, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 08907, Spain

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GSK Investigational Site

Getafe, 28905, Spain

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GSK Investigational Site

Las Palmas, 35020, Spain

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GSK Investigational Site

Madrid, 28007, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28222, Spain

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GSK Investigational Site

Murcia, 30120, Spain

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GSK Investigational Site

Santander, 39008, Spain

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GSK Investigational Site

Toledo, 45111, Spain

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GSK Investigational Site

Valencia, 46017, Spain

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GSK Investigational Site

Valencia, 46026, Spain

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GSK Investigational Site

Valladolid, 47012, Spain

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GSK Investigational Site

VigoPontevedra, 36200, Spain

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GSK Investigational Site

Villajoyosa, 3570, Spain

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GSK Investigational Site

Stockholm, SE-171 76, Sweden

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MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Autoimmune Diseases

Interventions

belimumab; Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

EOS forms were missing for 13 participants from the Eligible Population. However, as these participants contributed data to all analyses presented, they were included under 'Completed' participants.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 20, 2012
• Study Start: February 21, 2013
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: March 20, 2026
• Results First Posted: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); AR (3); SE (1); IT (10); IL (9); AU (4); CA (5); SL (5); BE (1); DE (16); US (102); PT (1); ES (18)