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Belimumab Assessment of Safety in SLE (BASE)

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Placebo plus standard therapy
Belimumab 10 mg/kg plus standard therapy
Standard therapy
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Antibodies, Lupus, SLE, Systemic Lupus Erythematosus, Autoimmune Disease, Belimumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo plus standard therapy

Belimumab 10 mg/kg plus standard therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.

Full Information

First Posted
October 10, 2012
Last Updated
August 8, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01705977
Brief Title
Belimumab Assessment of Safety in SLE
Acronym
BASE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2012 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
August 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Antibodies, Lupus, SLE, Systemic Lupus Erythematosus, Autoimmune Disease, Belimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4019 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo plus standard therapy
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Belimumab 10 mg/kg plus standard therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo plus standard therapy
Intervention Description
Placebo plus standard therapy
Intervention Type
Biological
Intervention Name(s)
Belimumab 10 mg/kg plus standard therapy
Other Intervention Name(s)
BENLYSTA™
Intervention Description
Belimumab 10 mg/kg plus standard therapy
Intervention Type
Other
Intervention Name(s)
Standard therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Deaths - On Treatment Period (Week 52)
Description
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.
Time Frame
Up to Week 52 (On-treatment period)
Title
Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52)
Description
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.
Time Frame
Up to Week 52 (On-treatment period)
Title
Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
Description
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.
Time Frame
Up to Week 52 (On-treatment period)
Secondary Outcome Measure Information:
Title
Number of Deaths Reported - On-study Period (Week 52)
Description
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.
Time Frame
Up to Week 52 (On-study period)
Title
Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52)
Description
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.
Time Frame
Up to Week 52 (On-study period)
Title
Number of Participants With SAEs Reported During On-study Period (Week 52)
Description
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.
Time Frame
Up to Week 52 (On-study period)
Title
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
Description
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).
Time Frame
Week 40 to Week 52
Title
Number of Participants With All-cause Mortality During Years 2 to 5
Description
Number of participants with all-cause mortality during years 2 to 5 has been presented.
Time Frame
From 2 years to 5 years
Title
Number of Participants With New Primary Malignancies During Years 2 to 5
Description
Number of participants with new primary malignancies during years 2 to 5 has been presented.
Time Frame
From 2 years to 5 years

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://clinicalstudydatarequest.com/Posting.aspx?ID=20766
Citations:
Citation
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
Results Reference
background

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Belimumab Assessment of Safety in SLE

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