Belimumab Assessment of Safety in SLE (BASE)

A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: Placebo plus standard therapy; Biological: Belimumab 10 mg/kg plus standard therapy; Other: Standard therapy

Detailed Description

Study participants receive standard therapy for SLE in addition to receiving the study drug, either placebo (no active medicine) or belimumab. The controlled period of the study is 52 weeks. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo. After completion of the 52-week study period, participants will be contacted by phone annually for 4 more years to assess health status.

Following the 52-week controlled period, participants who wish to continue treatment with belimumab may be able to do so by being prescribed commercially available belimumab. If belimumab is not commercially available in the participant's country, the participant may be able to receive belimumab under a separate continuation protocol.

• Study Type: Interventional
• Enrollment (Actual): 4019
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
    • GSK Investigational Site
  • Buenos Aires, Argentina, C1046AAQ
    • GSK Investigational Site
  • Cordoba, Argentina, 5004
    • GSK Investigational Site
  • Mendoza, Argentina, 5500
    • GSK Investigational Site
  • Tucuman, Argentina, T4000ICL
    • GSK Investigational Site
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1425
      • GSK Investigational Site
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1035
      • GSK Investigational Site
    • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1425ASQ
      • GSK Investigational Site
    • La Plata, Buenos Aires, Argentina, 1900
      • GSK Investigational Site
    • Lanús, Buenos Aires, Argentina, B1824KAJ
      • GSK Investigational Site
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • GSK Investigational Site
    • Zarate, Buenos Aires, Argentina, 2800
      • GSK Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000BIF
      • GSK Investigational Site
    • Rosario, Santa Fe, Argentina, S2002KDS
      • GSK Investigational Site
    • Venado Tuerto, Santa Fe, Argentina, 2600
      • GSK Investigational Site
  • Tucumán
    • San Miguel de Tucumán, Tucumán, Argentina, T4000BRD
      • GSK Investigational Site
• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • GSK Investigational Site
  • New South Wales
    • Sydney, New South Wales, Australia, 2153
      • GSK Investigational Site
  • Queensland
    • Herston, Queensland, Australia, 4029
      • GSK Investigational Site
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • GSK Investigational Site
• Brazil
  • Belo Horizonte, Minas Gerais, Brazil, 30150-221
    • GSK Investigational Site
  • Campinas, Brazil, 13083-888
    • GSK Investigational Site
  • Campo Grande, Brazil, 79080-190
    • GSK Investigational Site
  • Goiania, Brazil, 74110-120
    • GSK Investigational Site
  • Lajeado, Brazil, 95900-000
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 22411-001
    • GSK Investigational Site
  • Salvador, Brazil, 40050-410
    • GSK Investigational Site
  • São Paulo, Brazil, 01323-020
    • GSK Investigational Site
  • São Paulo, Brazil, 04032-060
    • GSK Investigational Site
  • Mato Grosso
    • Cuiaba, Mato Grosso, Brazil, 78.040-360
      • GSK Investigational Site
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • GSK Investigational Site
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • GSK Investigational Site
  • Paraná
    • Curitiba, Paraná, Brazil, 80440-080
      • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • GSK Investigational Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90560-030
      • GSK Investigational Site
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • GSK Investigational Site
  • São Paulo
    • Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
      • GSK Investigational Site
    • Sao Paulo, São Paulo, Brazil, 01244-030
      • GSK Investigational Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • GSK Investigational Site
  • Plovdiv, Bulgaria, 4000
    • GSK Investigational Site
  • Plovdiv, Bulgaria, 4002
    • GSK Investigational Site
  • Ruse, Bulgaria, 7002
    • GSK Investigational Site
  • Shumen, Bulgaria, 9700
    • GSK Investigational Site
  • Sofia, Bulgaria, 1612
    • GSK Investigational Site
  • Stara Zagora, Bulgaria, 6001
    • GSK Investigational Site
  • Targovisthe, Bulgaria, 7700
    • GSK Investigational Site
  • Veliko Tarnovo, Bulgaria, 5000
    • GSK Investigational Site
• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • GSK Investigational Site
    • Vaughan, Ontario, Canada, L4L 4Y7
      • GSK Investigational Site
• Chile
  • La Serena, Chile, 68650
    • GSK Investigational Site
  • Santigo, Chile, 7500010
    • GSK Investigational Site
• Colombia
  • Armenia, Colombia, 55860
    • GSK Investigational Site
  • Barranquilla, Colombia, 080002
    • GSK Investigational Site
  • Bogota, Colombia, 110111
    • GSK Investigational Site
  • Bucaramanga, Colombia, 680005
    • GSK Investigational Site
  • Chia, Colombia, 250007
    • GSK Investigational Site
  • Medellin, Colombia, 050018
    • GSK Investigational Site
• Croatia
  • Osijek, Croatia, 31000
    • GSK Investigational Site
  • Rijeka, Croatia, 51000
    • GSK Investigational Site
• Czechia
  • Brno, Czechia, 65691
    • GSK Investigational Site
  • Praha 2, Czechia, 128 50
    • GSK Investigational Site
  • Praha 5, Czechia, 150 06
    • GSK Investigational Site
  • Zlin, Czechia, 760 01
    • GSK Investigational Site
• Estonia
  • Tallinn, Estonia, 10117
    • GSK Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • GSK Investigational Site
  • Shatin, Hong Kong
    • GSK Investigational Site
• Hungary
  • Budapest, Hungary, 1023
    • GSK Investigational Site
  • Budapest, Hungary, 1097
    • GSK Investigational Site
  • Debrecen, Hungary, 4031
    • GSK Investigational Site
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Gyula, Hungary, 5700
    • GSK Investigational Site
  • Zalaegerszeg, Hungary, 8900
    • GSK Investigational Site
• Indonesia
  • Bandung, Indonesia, 40161
    • GSK Investigational Site
  • Denpasar, Indonesia, 80114
    • GSK Investigational Site
  • Malang, Indonesia, 65111
    • GSK Investigational Site
  • Palembang, Indonesia, 30126
    • GSK Investigational Site
  • Yogyakarta, Indonesia, 55281
    • GSK Investigational Site
• Italy
  • Pisa, Italy, 56126
    • GSK Investigational Site
  • Lazio
    • Roma, Lazio, Italy, 00151
      • GSK Investigational Site
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • GSK Investigational Site
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • GSK Investigational Site
  • Veneto
    • Padova, Veneto, Italy, 35128
      • GSK Investigational Site
• Korea, Republic of
  • Daegu, Korea, Republic of, 700-721
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 301-721
    • GSK Investigational Site
  • Daejeon, Korea, Republic of, 302-799
    • GSK Investigational Site
  • Gwangju, Korea, Republic of, 501-757
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 400-711
    • GSK Investigational Site
  • Jeonju-si, Korea, Republic of, 561-712
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 120-752
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 137-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 143-729
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 133-792
    • GSK Investigational Site
  • Suwon, Korea, Republic of, 16247
    • GSK Investigational Site
  • Suwon-si, Korea, Republic of, 443-380
    • GSK Investigational Site
• Lithuania
  • Klaipeda, Lithuania, LT-92288
    • GSK Investigational Site
• Malaysia
  • Ipoh, Malaysia, 30990
    • GSK Investigational Site
  • Kota Bahru, Malaysia, 15586
    • GSK Investigational Site
  • Kota Kinabalu, Malaysia, 88586
    • GSK Investigational Site
  • Kuala Lumpur, Malaysia, 56000
    • GSK Investigational Site
  • Kuala Terengganu, Malaysia, 20400
    • GSK Investigational Site
  • Selangor, Malaysia, 68100
    • GSK Investigational Site
  • Seremban, Negeri Sembilan, Malaysia, 70300
    • GSK Investigational Site
• Mexico
  • D.F, Mexico, 6726
    • GSK Investigational Site
  • Guadalajara, Mexico, 44620
    • GSK Investigational Site
  • Mexico, Mexico, 7760
    • GSK Investigational Site
  • Mexico, Mexico, 14000
    • GSK Investigational Site
  • San Luis Potosí, Mexico, 78200
    • GSK Investigational Site
  • San Luis Potosí, Mexico, 78240
    • GSK Investigational Site
  • Torreon, Mexico, 27000
    • GSK Investigational Site
  • Coahuila
    • Torreon, Coahuila, Mexico, 27000
      • GSK Investigational Site
  • Estado De México
    • Cuautitlan Izcalli, Estado De México, Mexico, 54769
      • GSK Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44158
      • GSK Investigational Site
    • Guadalajara, Jalisco, Mexico, 44690
      • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64718
      • GSK Investigational Site
  • Yucatán
    • Merida, Yucatán, Mexico, 97130
      • GSK Investigational Site
• New Zealand
  • Auckland, New Zealand, 622
    • GSK Investigational Site
  • Wellington, New Zealand, 6011
    • GSK Investigational Site
• Peru
  • Arequipa, Peru, 4017
    • GSK Investigational Site
  • Lima, Peru, 01
    • GSK Investigational Site
  • Lima, Peru, Lima 33
    • GSK Investigational Site
  • Lima, Peru, Lima 41
    • GSK Investigational Site
  • Lima, Peru, Lima 31
    • GSK Investigational Site
  • Lima, Peru, Lima 29
    • GSK Investigational Site
  • Lima, Peru, 11
    • GSK Investigational Site
  • Lima, Peru, 15048
    • GSK Investigational Site
• Philippines
  • Angeles City, Pampanga, Philippines, 2009
    • GSK Investigational Site
  • Cebu City, Philippines, 6000
    • GSK Investigational Site
  • Davao City, Philippines, 8000
    • GSK Investigational Site
  • Iloilo City, Philippines, 5000
    • GSK Investigational Site
  • Las Pinas, Philippines, 1740
    • GSK Investigational Site
  • Manila, Philippines, 1000
    • GSK Investigational Site
  • Manila, Philippines, 1510
    • GSK Investigational Site
  • Quezon City, Philippines, 1102
    • GSK Investigational Site
• Poland
  • Bydgoszcz, Poland, 85-168
    • GSK Investigational Site
  • Gdansk, Poland, 80-952
    • GSK Investigational Site
  • Krakow, Poland, 31-066
    • GSK Investigational Site
• Portugal
  • Almada, Portugal, 2801-915
    • GSK Investigational Site
  • Coimbra, Portugal, 3000-075
    • GSK Investigational Site
  • Lisboa, Portugal, 1649-035
    • GSK Investigational Site
  • Lisboa, Portugal, 1050-034
    • GSK Investigational Site
  • Porto, Portugal, 4099-001
    • GSK Investigational Site
  • Porto, Portugal, 4200-319
    • GSK Investigational Site
  • Viseu, Portugal, 3504-509
    • GSK Investigational Site
• Romania
  • Bucharest, Romania, 020125
    • GSK Investigational Site
  • Galati, Romania, 800578
    • GSK Investigational Site
  • Targu Mures, Romania, 540142
    • GSK Investigational Site
• Russian Federation
  • Barnaul, Russian Federation, 656045
    • GSK Investigational Site
  • Kemerovo, Russian Federation, 650066
    • GSK Investigational Site
  • Kursk, Russian Federation, 305007
    • GSK Investigational Site
  • Moscow, Russian Federation, 119991
    • GSK Investigational Site
  • Saint-Petersburg, Russian Federation, 190068
    • GSK Investigational Site
  • Saratov, Russian Federation, 410053
    • GSK Investigational Site
  • St. Petersburg, Russian Federation, 194044
    • GSK Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • GSK Investigational Site
  • Belgrade, Serbia, 11080
    • GSK Investigational Site
  • Krusevac, Serbia, 37000
    • GSK Investigational Site
  • Niska Banja, Serbia, 18205
    • GSK Investigational Site
  • Sabac, Serbia, 15000
    • GSK Investigational Site
• Slovakia
  • Piestany, Slovakia, 921 12
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 8035
    • GSK Investigational Site
  • Bilbao, Spain, 48013
    • GSK Investigational Site
  • Castellón, Spain, 12004
    • GSK Investigational Site
  • Cordoba, Spain, 140044
    • GSK Investigational Site
  • Getafe/Madrid, Spain, 28905
    • GSK Investigational Site
  • Granada, Spain, 18012
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Malaga, Spain, 29009
    • GSK Investigational Site
  • Sevilla, Spain, 41009
    • GSK Investigational Site
  • Seville, Spain, 4110
    • GSK Investigational Site
  • Valencia, Spain, 46017
    • GSK Investigational Site
  • Valencia, Spain, 46026
    • GSK Investigational Site
  • Vilajoyosa, Spain, 3570
    • GSK Investigational Site
• Switzerland
  • St. Gallen, Switzerland, 9007
    • GSK Investigational Site
  • Zuerich, Switzerland, 8006
    • GSK Investigational Site
• Taiwan
  • Chiayi County, Taiwan, 613
    • GSK Investigational Site
  • Gueishan Township,Taoyuan County, Taiwan, 333
    • GSK Investigational Site
  • Kaohsiung, Taiwan, 833
    • GSK Investigational Site
  • Taichung, Taiwan, 404
    • GSK Investigational Site
  • Taichung, Taiwan, 402
    • GSK Investigational Site
  • Taipei, Taiwan, 100
    • GSK Investigational Site
  • Taipei, Taiwan, 11490
    • GSK Investigational Site
  • Taipei, Taiwan, 106
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10400
    • GSK Investigational Site
  • Bangkok, Thailand, 10700
    • GSK Investigational Site
  • Chiang Mai, Thailand, 50200
    • GSK Investigational Site
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • GSK Investigational Site
  • Donetsk, Ukraine, 83114
    • GSK Investigational Site
  • Donetsk, Ukraine, 83045
    • GSK Investigational Site
  • Ivano-Frankivsk, Ukraine, 76018
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61176
    • GSK Investigational Site
  • Kyiv, Ukraine, 1601
    • GSK Investigational Site
  • Kyiv, Ukraine, 4114
    • GSK Investigational Site
  • Lviv, Ukraine, 79010
    • GSK Investigational Site
  • Odesa, Ukraine, 65026
    • GSK Investigational Site
  • Poltava, Ukraine, 36011
    • GSK Investigational Site
  • Ternopil, Ukraine, 46002
    • GSK Investigational Site
  • Uzhgorod, Ukraine, 88018
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21018
    • GSK Investigational Site
  • Vinnytsia, Ukraine, 21029
    • GSK Investigational Site
  • Vinnytsya, Ukraine, 21029
    • GSK Investigational Site
  • Zaporizhzhia, Ukraine, 69600
    • GSK Investigational Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35216
      • GSK Investigational Site
    • Huntsville, Alabama, United States, 35801
      • GSK Investigational Site
  • Arizona
    • Glendale, Arizona, United States, 85304
      • GSK Investigational Site
    • Mesa, Arizona, United States, 85202
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85032
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85037
      • GSK Investigational Site
  • California
    • Covina, California, United States, 91722
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92646
      • GSK Investigational Site
    • La Mesa, California, United States, 92020
      • GSK Investigational Site
    • Long Beach, California, United States, 90808
      • GSK Investigational Site
    • Los Angeles, California, United States, 90033
      • GSK Investigational Site
    • Murrieta, California, United States, 92563
      • GSK Investigational Site
    • Sacramento, California, United States, 95816
      • GSK Investigational Site
    • San Leandro, California, United States, 94578
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • GSK Investigational Site
    • Hialeah, Florida, United States, 33012
      • GSK Investigational Site
    • Tampa, Florida, United States, 33614
      • GSK Investigational Site
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • GSK Investigational Site
  • Michigan
    • Saint Clair Shores, Michigan, United States, 48081
      • GSK Investigational Site
    • West Bloomfield, Michigan, United States, 48322
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • GSK Investigational Site
  • Montana
    • Kalispell, Montana, United States, 59901
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10032
      • GSK Investigational Site
    • New York, New York, United States, 10016
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28204
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • GSK Investigational Site
    • Columbus, Ohio, United States, 43203
      • GSK Investigational Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • GSK Investigational Site
    • Wyomissing, Pennsylvania, United States, 19610
      • GSK Investigational Site
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
    • Rock Hill, South Carolina, United States, 29732
      • GSK Investigational Site
    • Summerville, South Carolina, United States, 29486
      • GSK Investigational Site
  • Tennessee
    • Hixson, Tennessee, United States, 37343-7908
      • GSK Investigational Site
    • Memphis, Tennessee, United States, 38119
      • GSK Investigational Site
  • Texas
    • Cypress, Texas, United States, 77429
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Houston, Texas, United States, 77004
      • GSK Investigational Site
    • Houston, Texas, United States, 77084
      • GSK Investigational Site
    • Houston, Texas, United States, 77034
      • GSK Investigational Site
    • McKinney, Texas, United States, 75071
      • GSK Investigational Site
    • Webster, Texas, United States, 77450
      • GSK Investigational Site
  • Virginia
    • Arlington, Virginia, United States, 22205-3606
      • GSK Investigational Site
  • Washington
    • Spokane, Washington, United States, 99204
      • GSK Investigational Site
  • West Virginia
    • Beckley, West Virginia, United States, 25801
      • GSK Investigational Site
    • Clarksburg, West Virginia, United States, 26301
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
• Active SLE disease.
• Autoantibody-positive.
• On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).

Key Exclusion Criteria:

• Pregnant or nursing.
• Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
• Have received a live vaccine within the past 30 days.
• Have severe active lupus kidney disease.
• Have severe active central nervous system (CNS) lupus.
• Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo plus standard therapy; Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.	Biological: Placebo plus standard therapy; Placebo plus standard therapy; Other: Standard therapy; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
Experimental: Belimumab 10 mg/kg plus standard therapy; Belimumab 10 mg/kg IV plus standard therapy; belimumab administered on Days 0, 14, 28, and then every 28 days thereafter through Week 48, with a final evaluation at Week 52 in the double-blind period.	Biological: Belimumab 10 mg/kg plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Other Names: BENLYSTA™; Other: Standard therapy; Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Deaths - On Treatment Period (Week 52)	Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than [>]50 percent [%]) of the time. The on-treatment period was the primary analysis period for safety analyses.	Up to Week 52 (On-treatment period)
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)	A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale [C-SSRS]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses.	Up to Week 52 (On-treatment period)
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)	An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.	Up to Week 52 (On-treatment period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52	The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (<=9 versus >=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1).	Week 40 to Week 52
Number of Deaths Reported - On-study Period (Week 52)	Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.	Up to Week 52 (On-study period)
Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)	A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis.	Up to Week 52 (On-study period)
Number of Participants With SAEs Reported During On-study Period (Week 52)	A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses.	Up to Week 52 (On-study period)
Number of Participants With All-cause Mortality During Years 2 to 5	Number of participants with all-cause mortality during years 2 to 5 has been presented.	From 2 years to 5 years
Number of Participants With New Primary Malignancies During Years 2 to 5	Number of participants with new primary malignancies during years 2 to 5 has been presented.	From 2 years to 5 years

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

General Publications

• Sheikh S, Scheinberg MA, Wei CC, Tegzova D, Stohl W, Acayaba de Toledo R, Mucenic T, Abello M, Maksimowicz-McKinnon K, Abud Mendoza C, Navarra S, Garcia M, Garcia de la Torre I, Ordi Ros J, Nami A, Levy R, Bass D, Ross J, Punwaney R, Harris J, Pierce A, Thorneloe K, Ji B, Roth D. Mortality and adverse events of special interest in adult patients with active, auto-antibody-positive systemic lupus erythematosus receiving intravenous belimumab (BASE): a global, randomised, double-blind, placebo-controlled, multicentre Phase 4 trial. Lancet Rheumatol. 2020; DOI: 10.1016/S2665-9913(20)30355-6

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2012
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): August 10, 2022

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimated): October 15, 2012

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; Antibodies; Autoimmune Disease; Belimumab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Belimumab
• Other Study ID Numbers: 115467; 2011-005667-25 (EudraCT Number); HGS1006-C1113 (Other Identifier: Human Genome Sciences Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study is available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR