A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
NCT ID: NCT00712933
Last Updated: 2019-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
738 participants
INTERVENTIONAL
2008-05-30
2016-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
1 mg/kg dose of belimumab given IV every 28 days.
belimumab
Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
2.
10 mg/kg dose of belimumab given IV every 28 days.
belimumab
Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Interventions
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belimumab
Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc., a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Vienna, , Austria
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Liège, , Belgium
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Salvador, Estado de Bahia, Brazil
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Goiânia, Goiás, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Recife, Pernambuco, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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Campinas, , Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Viña del Mar, Región de Valparaíso, Chile
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Santiago, , Chile
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Medellín, , Colombia
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Brno - Bohunice, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Suresnes, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Erlangen, Bavaria, Germany
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Frankfurt am Main, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Mainz, Rhineland-Palatinate, Germany
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Leipzig, Saxony, Germany
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Jena, Thuringia, Germany
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Berlin, , Germany
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Berlin, , Germany
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Kiel, , Germany
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Chai Wan, , Hong Kong
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New Territories, , Hong Kong
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Bangalore, , India
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Hyderabad, Andhra Pradesh, , India
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Lucknow, , India
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Secunderabad, , India
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Trivandrum, , India
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Beersheba, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Rehovot, , Israel
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Roma, , Italy
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Rotterdam, , Netherlands
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Surco, Lima region, Peru
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Callao, , Peru
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Lima, , Peru
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Cebu City, , Philippines
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Davao City, , Philippines
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Las Piñas, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Sampaloc Manila, , Philippines
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Gmina Końskie, , Poland
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Piešťany, , Slovakia
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Busan, , South Korea
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Daejeon, , South Korea
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Incheon, , South Korea
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Pusan, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Suwon, Kyonggi-do, , South Korea
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Barcelona, , Spain
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Madrid, , Spain
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Stockholm, , Sweden
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Dalin Township, Chiayi County, , Taiwan
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Gueishan Township,Taoyuan County, , Taiwan
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
Countries
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References
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Bruce IN, Urowitz M, van Vollenhoven R, Aranow C, Fettiplace J, Oldham M, Wilson B, Molta C, Roth D, Gordon D. Long-term organ damage accrual and safety in patients with SLE treated with belimumab plus standard of care. Lupus. 2016 Jun;25(7):699-709. doi: 10.1177/0961203315625119. Epub 2016 Mar 1.
van Vollenhoven RF, Navarra SV, Levy RA, Thomas M, Heath A, Lustine T, Adamkovic A, Fettiplace J, Wang ML, Ji B, Roth D. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab: a Phase III study extension. Rheumatology (Oxford). 2020 Feb 1;59(2):281-291. doi: 10.1093/rheumatology/kez279.
Urowitz MB, Ohsfeldt RL, Wielage RC, Dever JJ, Zakerifar M, Asukai Y, Ramachandran S, Joshi AV. Comparative analysis of long-term organ damage in patients with systemic lupus erythematosus using belimumab versus standard therapy: a post hoc longitudinal study. Lupus Sci Med. 2020 Oct;7(1):e000412. doi: 10.1136/lupus-2020-000412.
Other Identifiers
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2007-007648-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
112234
Identifier Type: -
Identifier Source: org_study_id
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