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GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Primary Purpose

Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Belimumab
Placebo
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 SLEDAI, Asia, placebo, BLys, PGA, BILAG, systemic lupus erythematosus, SELENA, Lupus, SRI, efficacy, B cell, SLE Flare Index, belimumab, safety, phase III, B lymphocyte

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years and older.
  • Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
  • Have active SLE disease.
  • Have positive anti-nuclear antibody (ANA) test results.
  • Are on a stable SLE treatment regimen.
  • Females of childbearing age are willing to use appropriate contraception

Exclusion Criteria:

  • Have received treatment with any B cell targeted therapy at any time.
  • Have received a biologic investigational agent in the past year.
  • Have received 3 or more courses of systemic corticosteroids in the past year.
  • Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have had a major organ transplant.
  • Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
  • Have a planned surgical procedure.
  • Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
  • Have required management of acute or chronic infections in the past 60 days.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
  • Have an IgA deficiency.
  • Have severe laboratory Abnormalities.
  • Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
  • Suicidal behavior or ideation.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Belimumab

Placebo

Arm Description

10mg/kg

placebo

Outcomes

Primary Outcome Measures

Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).

Secondary Outcome Measures

Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.
Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.
SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.
Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.
Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.
Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase
SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.

Full Information

First Posted
April 28, 2011
Last Updated
September 20, 2019
Sponsor
GlaxoSmithKline
Collaborators
Human Genome Sciences Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01345253
Brief Title
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
Official Title
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2011 (Actual)
Primary Completion Date
September 15, 2015 (Actual)
Study Completion Date
September 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
Collaborators
Human Genome Sciences Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.
Detailed Description
The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
SLEDAI, Asia, placebo, BLys, PGA, BILAG, systemic lupus erythematosus, SELENA, Lupus, SRI, efficacy, B cell, SLE Flare Index, belimumab, safety, phase III, B lymphocyte

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
709 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Belimumab
Arm Type
Experimental
Arm Description
10mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Belimumab
Intervention Description
10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
Primary Outcome Measure Information:
Title
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Description
SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Description
The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.
Time Frame
Baseline (Day 0) and Week 52
Title
Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.
Description
SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Time Frame
Baseline (Day 0) and Week 52
Title
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.
Description
Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.
Time Frame
Week 52
Title
Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.
Description
Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
Time Frame
52 weeks
Title
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase
Description
SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.
Time Frame
Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years and older. Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria. Have active SLE disease. Have positive anti-nuclear antibody (ANA) test results. Are on a stable SLE treatment regimen. Females of childbearing age are willing to use appropriate contraception Exclusion Criteria: Have received treatment with any B cell targeted therapy at any time. Have received a biologic investigational agent in the past year. Have received 3 or more courses of systemic corticosteroids in the past year. Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0. Have severe lupus kidney disease. Have active central nervous system (CNS) lupus. Have had a major organ transplant. Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE. Have a planned surgical procedure. Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix. Have required management of acute or chronic infections in the past 60 days. Have current drug or alcohol abuse or dependence. Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C. Have an IgA deficiency. Have severe laboratory Abnormalities. Have had anaphylactic reaction to X-ray contrast agents or biologic agents. Suicidal behavior or ideation.
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
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Facility Name
GSK Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
GSK Investigational Site
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Facility Name
GSK Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
GSK Investigational Site
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
GSK Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
GSK Investigational Site
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
GSK Investigational Site
City
Xian
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Facility Name
GSK Investigational Site
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
GSK Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
GSK Investigational Site
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650101
Country
China
Facility Name
GSK Investigational Site
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
GSK Investigational Site
City
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
GSK Investigational Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
GSK Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
275-8580
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
739-0002
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
GSK Investigational Site
City
Hyogo
ZIP/Postal Code
675-8545
Country
Japan
Facility Name
GSK Investigational Site
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
GSK Investigational Site
City
Okayama
ZIP/Postal Code
710-0824
Country
Japan
Facility Name
GSK Investigational Site
City
Okinawa
ZIP/Postal Code
901-0243
Country
Japan
Facility Name
GSK Investigational Site
City
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
GSK Investigational Site
City
Busan
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Daegu
ZIP/Postal Code
700-721
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
Seoul
ZIP/Postal Code
110-744
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
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Suwon, Kyonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29295825
Citation
Zhang F, Bae SC, Bass D, Chu M, Egginton S, Gordon D, Roth DA, Zheng J, Tanaka Y. A pivotal phase III, randomised, placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China, Japan and South Korea. Ann Rheum Dis. 2018 Mar;77(3):355-363. doi: 10.1136/annrheumdis-2017-211631. Epub 2018 Jan 2.
Results Reference
background
PubMed Identifier
35428697
Citation
Zhang F, Zheng J, Li Y, Wang G, Wang M, Su Y, Gu J, Li X, Bass D, Chu M, Curtis P, DeRose K, Kurrasch R, Lowe J, Meizlik P, Roth DA. Phase 3, long-term, open-label extension period of safety and efficacy of belimumab in patients with systemic lupus erythematosus in China, for up to 6 years. RMD Open. 2022 Apr;8(1):e001669. doi: 10.1136/rmdopen-2021-001669.
Results Reference
derived
PubMed Identifier
34741731
Citation
Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6.
Results Reference
derived
PubMed Identifier
34628605
Citation
Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9.
Results Reference
derived
PubMed Identifier
34531304
Citation
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Results Reference
derived
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived

Learn more about this trial

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

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