Belimumab 10 mg/kg plus standard therapy ( DrugBank: Belimumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
49全身性エリテマトーデス2

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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sponsor
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT01632241
(ClinicalTrials.gov)
February 19, 201328/6/2012Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Drug: Standard therapyHuman Genome Sciences Inc., a GSK CompanyGlaxoSmithKlineCompleted18 YearsN/AAll503Phase 4United States;Brazil;Colombia;France;South Africa;United Kingdom
2NCT01705977
(ClinicalTrials.gov)
November 27, 201210/10/2012Belimumab Assessment of Safety in SLEA 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 BelimumabSystemic Lupus ErythematosusBiological: Placebo plus standard therapy;Biological: Belimumab 10 mg/kg plus standard therapy;Other: Standard therapyGlaxoSmithKlineNULLCompleted18 YearsN/AAll4019Phase 4United States;Argentina;Australia;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czechia;Estonia;Hong Kong;Hungary;Indonesia;Italy;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Peru;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Taiwan;Thailand;Ukraine;Czech Republic;Norway