Belimumab Assessment of Safety in SLE

NCT ID: NCT01705977

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 4019 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-27
• Study Completion Date: 2022-08-10

Brief Summary

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.

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo plus standard therapy

Intervention Type: BIOLOGICAL

Placebo plus standard therapy

Standard therapy

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Belimumab 10 mg/kg plus standard therapy

Intervention Type: BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Standard therapy

Intervention Type: OTHER

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.

Interventions

Placebo plus standard therapy

Placebo plus standard therapy

Intervention Type: BIOLOGICAL

Belimumab 10 mg/kg plus standard therapy

Belimumab 10 mg/kg plus standard therapy

Intervention Type: BIOLOGICAL

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.

Intervention Type: OTHER

Other Intervention Names

BENLYSTA™

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Glendale, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Covina, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

La Mesa, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Murrieta, California, United States

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Leandro, California, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Cedar Rapids, Iowa, United States

GSK Investigational Site

Saint Clair Shores, Michigan, United States

GSK Investigational Site

West Bloomfield, Michigan, United States

GSK Investigational Site

Jackson, Mississippi, United States

GSK Investigational Site

Kalispell, Montana, United States

GSK Investigational Site

Las Vegas, Nevada, United States

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New York, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Duncansville, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Orangeburg, South Carolina, United States

GSK Investigational Site

Rock Hill, South Carolina, United States

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Summerville, South Carolina, United States

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Hixson, Tennessee, United States

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Memphis, Tennessee, United States

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Cypress, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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Webster, Texas, United States

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Arlington, Virginia, United States

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Spokane, Washington, United States

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Beckley, West Virginia, United States

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Clarksburg, West Virginia, United States

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Capital Federal, Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

GSK Investigational Site

La Plata, Buenos Aires, Argentina

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Lanús, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Zárate, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

GSK Investigational Site

Rosario, Santa Fe Province, Argentina

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Venado Tuerto, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

GSK Investigational Site

Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Mendoza, , Argentina

GSK Investigational Site

San Miguel de Tucumán, , Argentina

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Garran, Australian Capital Territory, Australia

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Sydney, New South Wales, Australia

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Herston, Queensland, Australia

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Fitzroy, Victoria, Australia

GSK Investigational Site

Cuiabá, Mato Grosso, Brazil

GSK Investigational Site

Belo Horizonte, Minas Gerais, Brazil

GSK Investigational Site

Juiz de Fora, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

GSK Investigational Site

Itajaí, Santa Catarina, Brazil

GSK Investigational Site

São José do Rio Preto, São Paulo, Brazil

GSK Investigational Site

São Paulo, São Paulo, Brazil

GSK Investigational Site

Belo Horizonte, Minas Gerais, , Brazil

GSK Investigational Site

Campinas, , Brazil

GSK Investigational Site

Campo Grande, , Brazil

GSK Investigational Site

Goiânia, , Brazil

GSK Investigational Site

Lajeado, , Brazil

GSK Investigational Site

Rio de Janeiro, , Brazil

GSK Investigational Site

Salvador, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

São Paulo, , Brazil

GSK Investigational Site

Pleven, , Bulgaria

GSK Investigational Site

Plovdiv, , Bulgaria

GSK Investigational Site

Plovdiv, , Bulgaria

GSK Investigational Site

Rousse, , Bulgaria

GSK Investigational Site

Shumen, , Bulgaria

GSK Investigational Site

Sofia, , Bulgaria

GSK Investigational Site

Stara Zagora, , Bulgaria

GSK Investigational Site

Targovisthe, , Bulgaria

GSK Investigational Site

Veliko Tarnovo, , Bulgaria

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Vaughan, Ontario, Canada

GSK Investigational Site

La Serena, , Chile

GSK Investigational Site

Santigo, , Chile

GSK Investigational Site

Armenia, , Colombia

GSK Investigational Site

Barranquilla, , Colombia

GSK Investigational Site

Bogotá, , Colombia

GSK Investigational Site

Bucaramanga, , Colombia

GSK Investigational Site

Chía, , Colombia

GSK Investigational Site

Medellín, , Colombia

GSK Investigational Site

Osijek, , Croatia

GSK Investigational Site

Rijeka, , Croatia

GSK Investigational Site

Brno, , Czechia

GSK Investigational Site

Prague, , Czechia

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Prague, , Czechia

GSK Investigational Site

Zlín, , Czechia

GSK Investigational Site

Tallinn, , Estonia

GSK Investigational Site

Hong Kong, , Hong Kong

GSK Investigational Site

Shatin, , Hong Kong

GSK Investigational Site

Budapest, , Hungary

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Budapest, , Hungary

GSK Investigational Site

Debrecen, , Hungary

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Debrecen, , Hungary

GSK Investigational Site

Gyula, , Hungary

GSK Investigational Site

Zalaegerszeg, , Hungary

GSK Investigational Site

Bandung, , Indonesia

GSK Investigational Site

Denpasar, , Indonesia

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Malang, , Indonesia

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Palembang, , Indonesia

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Yogyakarta, , Indonesia

GSK Investigational Site

Rome, Lazio, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Florence, Tuscany, Italy

GSK Investigational Site

Padua, Veneto, Italy

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Pisa, , Italy

GSK Investigational Site

Klaipėda, , Lithuania

GSK Investigational Site

Ipoh, , Malaysia

GSK Investigational Site

Kota Bharu, , Malaysia

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Kota Kinabalu, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Selangor, , Malaysia

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Kuala Terengganu, , Malaysia

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Seremban, Negeri Sembilan, , Malaysia

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Torreón, Coahuila, Mexico

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Guadalajara, Jalisco, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

GSK Investigational Site

Cuautitlán Izcalli, State of Mexico, Mexico

GSK Investigational Site

Mérida, Yucatán, Mexico

GSK Investigational Site

D.F, , Mexico

GSK Investigational Site

Guadalajara, , Mexico

GSK Investigational Site

México, , Mexico

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México, , Mexico

GSK Investigational Site

San Luis Potosí City, , Mexico

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San Luis Potosí City, , Mexico

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Torreón, , Mexico

GSK Investigational Site

Auckland, , New Zealand

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Wellington, , New Zealand

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Arequipa, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

GSK Investigational Site

Angeles City, Pampanga, , Philippines

GSK Investigational Site

Cebu City, , Philippines

GSK Investigational Site

Davao City, , Philippines

GSK Investigational Site

Iloilo City, , Philippines

GSK Investigational Site

Las Piñas, , Philippines

GSK Investigational Site

Manila, , Philippines

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Manila, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Gdansk, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Almada, , Portugal

GSK Investigational Site

Coimbra, , Portugal

GSK Investigational Site

Lisbon, , Portugal

GSK Investigational Site

Lisbon, , Portugal

GSK Investigational Site

Porto, , Portugal

GSK Investigational Site

Porto, , Portugal

GSK Investigational Site

Viseu, , Portugal

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Galati, , Romania

GSK Investigational Site

Târgu Mureş, , Romania

GSK Investigational Site

Barnaul, , Russia

GSK Investigational Site

Kemerovo, , Russia

GSK Investigational Site

Kursk, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

Belgrade, , Serbia

GSK Investigational Site

Belgrade, , Serbia

GSK Investigational Site

Kruševac, , Serbia

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Niška Banja, , Serbia

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Šabac, , Serbia

GSK Investigational Site

Piešťany, , Slovakia

GSK Investigational Site

Daegu, , South Korea

GSK Investigational Site

Daejeon, , South Korea

GSK Investigational Site

Daejeon, , South Korea

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Gwangju, , South Korea

GSK Investigational Site

Incheon, , South Korea

GSK Investigational Site

Jeonju, , South Korea

GSK Investigational Site

Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

GSK Investigational Site

Suwon, , South Korea

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Suwon, , South Korea

GSK Investigational Site

Barcelona, , Spain

GSK Investigational Site

Bilbao, , Spain

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Castellon, , Spain

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Córdoba, , Spain

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Getafe/Madrid, , Spain

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Granada, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Valencia, , Spain

GSK Investigational Site

Vilajoyosa, , Spain

GSK Investigational Site

Sankt Gallen, , Switzerland

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Zurich, , Switzerland

GSK Investigational Site

Chiayi County, , Taiwan

GSK Investigational Site

Gueishan Township,Taoyuan County, , Taiwan

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Kaohsiung City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Bangkok, , Thailand

GSK Investigational Site

Chiang Mai, , Thailand

GSK Investigational Site

Chernivtsi, , Ukraine

GSK Investigational Site

Donetsk, , Ukraine

GSK Investigational Site

Donetsk, , Ukraine

GSK Investigational Site

Ivano-Frankivsk, , Ukraine

GSK Investigational Site

Kharkiv, , Ukraine

GSK Investigational Site

Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

GSK Investigational Site

Odesa, , Ukraine

GSK Investigational Site

Poltava, , Ukraine

GSK Investigational Site

Ternopil, , Ukraine

GSK Investigational Site

Uzhhorod, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

GSK Investigational Site

Vinnytsia, , Ukraine

GSK Investigational Site

Zaporizhzhia, , Ukraine

Countries

United States; Argentina; Australia; Brazil; Bulgaria; Canada; Chile; Colombia; Croatia; Czechia; Estonia; Hong Kong; Hungary; Indonesia; Italy; Lithuania; Malaysia; Mexico; New Zealand; Peru; Philippines; Poland; Portugal; Romania; Russia; Serbia; Slovakia; South Korea; Spain; Switzerland; Taiwan; Thailand; Ukraine

References

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

Reference Type: BACKGROUND

Sheikh SZ, Scheinberg MA, Wei JC, Tegzova D, Stohl W, de Toledo RA, Mucenic T, Banfi MRA, Maksimowicz-McKinnon K, Abud-Mendoza C, Navarra S, Garcia M, Garcia-De La Torre I, Ros JO, Levy RA, Bass DL, Terres JR, Punwaney R, Harris J, Nami A, Pierce A, Thorneloe KS, Ji B, Roth DA. Mortality and adverse events of special interest with intravenous belimumab for adults with active, autoantibody-positive systemic lupus erythematosus (BASE): a multicentre, double-blind, randomised, placebo-controlled, phase 4 trial. Lancet Rheumatol. 2021 Feb;3(2):e122-e130. doi: 10.1016/S2665-9913(20)30355-6. Epub 2020 Dec 15.

Reference Type: DERIVED

PMID: 38279368 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2011-005667-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HGS1006-C1113

Identifier Type: OTHER

Identifier Source: secondary_id

115467

Identifier Type: -

Identifier Source: org_study_id