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CompletedNCT01345253Updated Oct 4, 2019Results posted

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

A Phase 3 interventional study of Belimumab and Placebo in Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline. Completed at 47 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-04.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
709
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Lupus Erythematosus, Systemic

1,222 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's enrollment of 709 is above the median of 50 across 881 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
709 participants (actual)

Study arms

  • Experimental
    Belimumab

    10mg/kg

    Drug: Belimumab

  • Placebo comparator
    Placebo

    placebo

    Drug: Placebo

Interventions

  • DrugBelimumab

    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.

  • DrugPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Week 52

Secondary outcomes

  1. 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.

    Time frame: Baseline (Day 0) and Week 52

  2. 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).

    Time frame: Baseline (Day 0) and Week 52

  3. 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 frame: Week 52

  4. 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).

    Time frame: 52 weeks

  5. 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.

    Time frame: Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

07

Results

Posted Dec 2, 2016
Limitations and caveats
The primary objective for DB was efficacy and the participant flow is aligned with the MITT population. The primary objective for OL is safety and includes only China par. from DB + additional 25 China par. from the Safety Pop who were not in MITT.

Participant flow

This study consisted of a 52 week blinded treatment period in Northeast Asia (China, Japan, Korea) which was followed by an optional open-label (OL) extension period in China for evaluation of belimumab in participants (par.) with active systemic lupus erythematosus (SLE).

Double-blind (DB) Phase (52 Weeks)
Participant flow — Double-blind (DB) Phase (52 Weeks)
MilestonePlaceboBelimumab 10 mg/kg
Started226451
Completed170372
Not completed5679
Withdrew: Adverse event2227
Withdrew: Lack of efficacy117
Withdrew: Protocol violation15
Withdrew: Met protocol defined stopping criteria61
Withdrew: Lost to follow-up38
Withdrew: Physician decision412
Withdrew: Withdrawal by subject919
Open-label Phase (Up to Year 5 Week 44)
Participant flow — Open-label Phase (Up to Year 5 Week 44)
MilestonePlaceboBelimumab 10 mg/kg
Started134290
Completed69146
Not completed65144
Withdrew: Adverse event718
Withdrew: Death01
Withdrew: Lack of efficacy37
Withdrew: Protocol violation25
Withdrew: Lost to follow-up46
Withdrew: Physician decision1124
Withdrew: Withdrawal by subject3782
Withdrew: Not recorded11

Outcome measures

PrimaryPercent 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).

Time frame:
Week 52
Reported as:
Number · Percentage of participants
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Percentage of participantsPlaceboBelimumab 10 mg/kg
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.40.153.8
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.0001 · Odds ratio (or): 1.99 · 95% CI 1.40 to 2.82Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement (C) levels (low C3 and/or C4 vs. no low C3 or C4).
SecondaryPercent 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.

Time frame:
Baseline (Day 0) and Week 52
Reported as:
Number · Percentage of participants
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Percentage of participantsPlaceboBelimumab 10 mg/kg
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.42.255.7
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.0001 · Odds ratio (or): 2.00 · 95% CI 1.41 to 2.83Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, Baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
SecondaryPercent 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).

Time frame:
Baseline (Day 0) and Week 52
Reported as:
Number · Percentage of participants
Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.
Percentage of participantsPlaceboBelimumab 10 mg/kg
Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.23.532.4
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Logistic · p = 0.0116 · Odds ratio (or): 1.76 · 95% CI 1.13 to 2.74Odds Ratio (95% CI) and p-value were estimated by a logistic regression model with independent variables treatment group, country, baseline SELENA SLEDAI score (\<=9 vs. \>=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
SecondaryNumber 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 frame:
Week 52
Reported as:
Median · Days
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.
DaysPlaceboBelimumab 10 mg/kg
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.0.0 (0.0 to 172.0)0.0 (0.0 to 213.5)
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Rank ANCOVA · p = 0.0288
SecondaryTime 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).

Time frame:
52 weeks
Reported as:
Median · Days
Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.
DaysPlaceboBelimumab 10 mg/kg
Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.NA (NA to NA)NA (NA to NA)
Statistical analysis
  • Placebo vs Belimumab 10 mg/kg · Regression, Cox · p = 0.0004 · Hazard ratio (hr): 0.50 · 95% CI 0.34 to 0.73
SecondaryPercent 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.

Time frame:
Weeks 24 and 48 for Years 2, 3, 4, 5 and 6
Reported as:
Number · Percentage of participants
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase
Percentage of participantsBelimumab 10mg/kg (Open-label Phase)
Week 24, Year 2, n=32666.0
Week 48, Year 2, n=29969.6
Week 24, Year 3, n=27172.3
Week 48, Year 3, n=24770.9
Week 24, Year 4, n=23371.7
Week 48, Year 4, n=19476.8
Week 24, Year 5, n= 15681.4
Week 48, Year 5, n= 8280.5
Week 24, Year 6, n= 3686.1
Week 48, Year 6, n= 560.0

Adverse events

Collected over Serious adverse events (SAEs) and non-SAEs were collected from study treatment start and until 16 weeks after the last infusion. The data presented for belimumab open-label group represents safety events period starting from the first belimumab date and up to Year 6 Week 44.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo (Double-blind Phase)1/235 (0.4%)43/235 (18.3%)108/235 (46%)
Belimumab 10 mg/kg (Double-blind Phase)0/470 (0%)58/470 (12.3%)207/470 (44%)
Belimumab 10 mg/kg (Open-label Phase)1/424 (0.2%)96/424 (22.6%)263/424 (62%)
Most frequent serious events
Showing 10 of 175
Most frequent serious events
EventPlacebo (Double-blind Phase)Belimumab 10 mg/kg (Double-blind Phase)Belimumab 10 mg/kg (Open-label Phase)
Lupus nephritisRenal and urinary disorders5/2355/47012/424
PyrexiaGeneral disorders4/2352/4701/424
Herpes zosterInfections and infestations2/2356/4706/424
OsteonecrosisMusculoskeletal and connective tissue disorders0/2350/4706/424
PneumoniaInfections and infestations1/2352/4704/424
Lung infectionInfections and infestations2/2350/4702/424
Salmonella sepsisInfections and infestations2/2350/4700/424
ProteinuriaRenal and urinary disorders2/2350/4700/424
SLE arthritisMusculoskeletal and connective tissue disorders2/2350/4700/424
AppendicitisInfections and infestations0/2352/4702/424
Most frequent other events
Showing 10 of 12
Most frequent other events
EventPlacebo (Double-blind Phase)Belimumab 10 mg/kg (Double-blind Phase)Belimumab 10 mg/kg (Open-label Phase)
Upper respiratory tract infectionInfections and infestations39/23565/470149/424
Viral upper respiratory tract infectionInfections and infestations15/23533/47059/424
NasopharyngitisInfections and infestations26/23556/47024/424
Urinary tract infectionInfections and infestations11/23521/47041/424
Upper respiratory tract infection bacterialInfections and infestations12/23516/47037/424
PyrexiaGeneral disorders17/23528/47036/424
Herpes zosterInfections and infestations10/23523/47034/424
CoughRespiratory, thoracic and mediastinal disorders16/23530/47030/424
HeadacheNervous system disorders16/23523/47020/424
DiarrhoeaGastrointestinal disorders14/23528/47028/424

Baseline characteristics

Age, Continuous
Age, Continuous(Years)PlaceboBelimumab 10 mg/kgTotal
Mean31.7 ± 9.1832.3 ± 9.6532.1 ± 9.50
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboBelimumab 10 mg/kgTotal
Female210419629
Male163248
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboBelimumab 10 mg/kgTotal
Asian - Central/South Asian Heritage246
Asian - East Asian Heritage195403598
Asian - Japanese Heritage244064
Asian - South East Asian Heritage437
Asian - Mixed Race112
08

Study locations

47 sites
  • GSK Investigational Site
    Hefei, Anhui 230001, China
  • GSK Investigational Site
    Guangzhou, Guangdong 510080, China
  • GSK Investigational Site
    Guangzhou, Guangdong 510260, China
  • GSK Investigational Site
    Guangzhou, Guangdong 510630, China
  • GSK Investigational Site
    Harbin, Heilongjiang 150001, China
  • GSK Investigational Site
    Changsha, Hunan 410008, China
  • GSK Investigational Site
    Changsha, Hunan 410011, China
  • GSK Investigational Site
    Nanjing, Jiangsu 210029, China
  • GSK Investigational Site
    Suzhou, Jiangsu 215006, China
  • GSK Investigational Site
    Xi'an, Shaanxi 710032, China
  • GSK Investigational Site
    Jinan, Shandong 250012, China
  • GSK Investigational Site
    Chengdu, Sichuan 610041, China
  • GSK Investigational Site
    Kunming, Yunnan 650101, China
  • GSK Investigational Site
    Hangzhou, Zhejiang 310009, China
  • GSK Investigational Site
    Beijing, 100029, China
  • GSK Investigational Site
    Beijing, 100032, China
  • GSK Investigational Site
    Beijing, 100044, China
  • GSK Investigational Site
    Chongqing, 400038, China
  • GSK Investigational Site
    Shanghai, 200001, China
  • GSK Investigational Site
    Shanghai, 200003, China
  • GSK Investigational Site
    Shanghai, 200025, China
  • GSK Investigational Site
    Shanghai, 200433, China
  • GSK Investigational Site
    Tianjin, 300052, China
  • GSK Investigational Site
    Chiba, 275-8580, Japan
  • GSK Investigational Site
    Ehime, 791-0295, Japan
  • GSK Investigational Site
    Fukuoka, 807-8555, Japan
  • GSK Investigational Site
    Fukuoka, 810-8563, Japan
  • GSK Investigational Site
    Hiroshima, 730-8619, Japan
  • GSK Investigational Site
    Hiroshima, 739-0002, Japan
  • GSK Investigational Site
    Hokkaido, 060-8604, Japan
  • GSK Investigational Site
    Hokkaido, 060-8648, Japan
  • GSK Investigational Site
    Hyōgo, 675-8545, Japan
  • GSK Investigational Site
    Miyagi, 980-8574, Japan
  • GSK Investigational Site
    Nagasaki, 852-8501, Japan
  • GSK Investigational Site
    Nagasaki, 857-1195, Japan
  • GSK Investigational Site
    Okayama, 710-0824, Japan
  • GSK Investigational Site
    Okinawa, 901-0243, Japan
  • GSK Investigational Site
    Tochigi, 321-0293, Japan
  • GSK Investigational Site
    Tokyo, 113-8431, Japan
  • GSK Investigational Site
    Busan, South Korea
  • GSK Investigational Site
    Daegu, 700-721, South Korea
  • GSK Investigational Site
    Incheon, 400-711, South Korea
  • GSK Investigational Site
    Seoul, 110-744, South Korea
  • GSK Investigational Site
    Seoul, 133-792, South Korea
  • GSK Investigational Site
    Seoul, 137-701, South Korea
  • GSK Investigational Site
    Seoul, South Korea
  • GSK Investigational Site
    Suwon, Kyonggi-do, 443-721, South Korea
09

References and documents

Publications

  • 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. PubMed 29295825 ↗
  • Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, Oon S, Henning C, Khamashta M, Quasny HA, Chauhan D, Askanase A, van Vollenhoven R, Nikpour M. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials. Lancet Rheumatol. 2024 Nov;6(11):e751-e761. doi: 10.1016/S2665-9913(24)00162-0. Epub 2024 Aug 26. PubMed 39208825 ↗
  • Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8. PubMed 39115551 ↗
  • Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023. PubMed 38216728 ↗
  • Suh CH, Lee Y, Yoo SB, Quasny H, Navarro Rojas AA, Hammer A, Song YW, Kang YM, Cho CS, Park W, Kwok SK, Lee SG, Chung WT, Bae SC. Efficacy and safety of intravenous belimumab in a subgroup of South Korean patients with systemic lupus erythematosus enrolled into a Phase 3, randomized, placebo-controlled trial in North East Asia. Int J Rheum Dis. 2024 Jan;27(1):e14997. doi: 10.1111/1756-185X.14997. Epub 2023 Dec 23. PubMed 38140854 ↗
  • Gomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253. PubMed 37228028 ↗
  • 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. PubMed 35428697 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01345253
Lead sponsor
GlaxoSmithKline
Collaborators
Human Genome Sciences Inc.
Responsible party
Sponsor
First posted
May 2, 2011
Start date
May 23, 2011
Primary completion
Sep 15, 2015
Completion
Sep 21, 2018
Results posted
Dec 2, 2016
Last update
Oct 4, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Belimumab

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