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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

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ClinicalTrials.gov Identifier: NCT01345253
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : December 2, 2016
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
Human Genome Sciences Inc.
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Interventions Drug: Belimumab
Drug: Placebo
Enrollment 709
Recruitment Details This study consisted of a screening period (up to 35 days), a 52 week blinded treatment period. An optional open-label treatment period and follow-up period for participants not receiving open-label treatment was included.
Pre-assignment Details A total of 707 participants (par.) were randomized, 705 received at least 1 dose of investigational product (Safety Population), 677 par. were included in the primary efficacy population (MITT Population) of which 663 were evaluable for the primary endpoint. The participant flow and baseline characteristics are presented for the MITT Population.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period. Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Period Title: Overall Study
Started 226 451
Completed 170 372
Not Completed 56 79
Reason Not Completed
Adverse Event             22             27
Lack of Efficacy             11             7
Protocol Violation             1             5
Met Protocol Defined Stopping Criteria             6             1
Lost to Follow-up             3             8
Physician Decision             4             12
Withdrawal by Subject             9             19
Arm/Group Title Placebo Belimumab 10 mg/kg Total
Hide Arm/Group Description Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period. Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period. Total of all reporting groups
Overall Number of Baseline Participants 226 451 677
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 226 participants 451 participants 677 participants
31.7  (9.18) 32.3  (9.65) 32.1  (9.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 451 participants 677 participants
Female
210
  92.9%
419
  92.9%
629
  92.9%
Male
16
   7.1%
32
   7.1%
48
   7.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 226 participants 451 participants 677 participants
Asian - Central/South Asian Heritage 2 4 6
Asian - East Asian Heritage 195 403 598
Asian - Japanese Heritage 24 40 64
Asian - South East Asian Heritage 4 3 7
Asian - Mixed Race 1 1 2
1.Primary Outcome
Title Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intention-to-Treat (MITT) Population: all participants who were randomized and treated with at least one dose of study treatment, with exclusion of participants from the site 086485.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Overall Number of Participants Analyzed 217 446
Measure Type: Number
Unit of Measure: Percentage of participants
40.1 53.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
1.40 to 2.82
Estimation Comments Odds 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).
2.Secondary Outcome
Title Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time points were analyzed.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Overall Number of Participants Analyzed 218 447
Measure Type: Number
Unit of Measure: Percentage of participants
42.2 55.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
1.41 to 2.83
Estimation Comments Odds 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).
3.Secondary Outcome
Title Percent of Participants With SRI7 Response at Week 52.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population. Only those participants available at the specified time point were analyzed.
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Overall Number of Participants Analyzed 183 367
Measure Type: Number
Unit of Measure: Percentage of participants
23.5 32.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0116
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.13 to 2.74
Estimation Comments Odds 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).
4.Secondary Outcome
Title Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks.
Hide 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 compaired 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Overall Number of Participants Analyzed 184 352
Median (Inter-Quartile Range)
Unit of Measure: Days
0.0
(0.0 to 172.0)
0.0
(0.0 to 213.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0288
Comments [Not Specified]
Method Rank ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
MITT Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
Overall Number of Participants Analyzed 226 451
Median (Inter-Quartile Range)
Unit of Measure: Days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Due to low event rates of participants in both treatment groups having severe SFI flares, the median time and interquartile range could not be estimated.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.50
Confidence Interval (2-Sided) 95%
0.34 to 0.73
Estimation Comments [Not Specified]
Time Frame On-treatment serious adverse events(SAEs)and non-serious adverse events(AEs)were collected from study treatment start and until the EXIT visit or follow-up contact which could be up to 16 weeks after the last infusion for participants withdrawing early.
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs were reported for the Safety Population consisted of all participants who received at least one dose of study drug.
 
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period. Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
All-Cause Mortality
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   43/235 (18.30%)   58/470 (12.34%) 
Blood and lymphatic system disorders     
Pancytopenia  1  1/235 (0.43%)  1/470 (0.21%) 
Histiocytosis haematophagic  1  1/235 (0.43%)  0/470 (0.00%) 
Leukopenia  1  1/235 (0.43%)  0/470 (0.00%) 
Cardiac disorders     
Cardiomyopathy  1  0/235 (0.00%)  1/470 (0.21%) 
Eye disorders     
Cataract  1  0/235 (0.00%)  1/470 (0.21%) 
Glaucoma  1  0/235 (0.00%)  1/470 (0.21%) 
Retinal detachment  1  0/235 (0.00%)  1/470 (0.21%) 
Gastrointestinal disorders     
Abdominal pain  1  0/235 (0.00%)  2/470 (0.43%) 
Allergic colitis  1  1/235 (0.43%)  0/470 (0.00%) 
Haemorrhoidal haemorrhage  1  0/235 (0.00%)  1/470 (0.21%) 
Lupus pancreatitis  1  0/235 (0.00%)  1/470 (0.21%) 
Oesophageal varices haemorrhage  1  1/235 (0.43%)  0/470 (0.00%) 
Pancreatitis chronic  1  0/235 (0.00%)  1/470 (0.21%) 
General disorders     
Pyrexia  1  4/235 (1.70%)  2/470 (0.43%) 
Generalised oedema  1  1/235 (0.43%)  0/470 (0.00%) 
Polyserositis  1  1/235 (0.43%)  0/470 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal  1  0/235 (0.00%)  2/470 (0.43%) 
Infections and infestations     
Herpes zoster  1  2/235 (0.85%)  6/470 (1.28%) 
Pneumonia  1  1/235 (0.43%)  2/470 (0.43%) 
Appendicitis  1  0/235 (0.00%)  2/470 (0.43%) 
Lung infection  1  2/235 (0.85%)  0/470 (0.00%) 
Pyelonephritis acute  1  0/235 (0.00%)  2/470 (0.43%) 
Salmonella sepsis  1  2/235 (0.85%)  0/470 (0.00%) 
Skin infection  1  1/235 (0.43%)  1/470 (0.21%) 
Arthritis salmonella  1  0/235 (0.00%)  1/470 (0.21%) 
Bacterial pyelonephritis  1  0/235 (0.00%)  1/470 (0.21%) 
Cellulitis  1  0/235 (0.00%)  1/470 (0.21%) 
Cellulitis streptococcal  1  1/235 (0.43%)  0/470 (0.00%) 
Cystitis  1  1/235 (0.43%)  0/470 (0.00%) 
Cytomegalovirus infection  1  0/235 (0.00%)  1/470 (0.21%) 
Disseminated tuberculosis  1  0/235 (0.00%)  1/470 (0.21%) 
Enteritis infectious  1  1/235 (0.43%)  0/470 (0.00%) 
Escherichia urinary tract infection  1  0/235 (0.00%)  1/470 (0.21%) 
Gastroenteritis  1  0/235 (0.00%)  1/470 (0.21%) 
Gastrointestinal fungal infection  1  1/235 (0.43%)  0/470 (0.00%) 
Infectious colitis  1  0/235 (0.00%)  1/470 (0.21%) 
Lymph node tuberculosis  1  1/235 (0.43%)  0/470 (0.00%) 
Meningitis tuberculous  1  0/235 (0.00%)  1/470 (0.21%) 
Otitis media acute  1  0/235 (0.00%)  1/470 (0.21%) 
Pneumonia bacterial  1  1/235 (0.43%)  0/470 (0.00%) 
Pneumonia mycoplasmal  1  0/235 (0.00%)  1/470 (0.21%) 
Pneumonia streptococcal  1  0/235 (0.00%)  1/470 (0.21%) 
Sepsis  1  0/235 (0.00%)  1/470 (0.21%) 
Spleen tuberculosis  1  1/235 (0.43%)  0/470 (0.00%) 
Tuberculosis liver  1  1/235 (0.43%)  0/470 (0.00%) 
Tuberculous pleurisy  1  0/235 (0.00%)  1/470 (0.21%) 
Upper respiratory tract infection bacterial  1  1/235 (0.43%)  0/470 (0.00%) 
Urinary tract infection enterococcal  1  1/235 (0.43%)  0/470 (0.00%) 
Viral upper respiratory tract infection  1  0/235 (0.00%)  1/470 (0.21%) 
Injury, poisoning and procedural complications     
Contusion  1  0/235 (0.00%)  1/470 (0.21%) 
Femoral neck fracture  1  1/235 (0.43%)  0/470 (0.00%) 
Fractured sacrum  1  0/235 (0.00%)  1/470 (0.21%) 
Humerus fracture  1  0/235 (0.00%)  1/470 (0.21%) 
Jaw fracture  1  0/235 (0.00%)  1/470 (0.21%) 
Ligament rupture  1  0/235 (0.00%)  1/470 (0.21%) 
Patella fracture  1  1/235 (0.43%)  0/470 (0.00%) 
Road traffic accident  1  0/235 (0.00%)  1/470 (0.21%) 
Scapula fracture  1  0/235 (0.00%)  1/470 (0.21%) 
Investigations     
Blood creatinine increased  1  1/235 (0.43%)  0/470 (0.00%) 
Metabolism and nutrition disorders     
Hyperkalaemia  1  0/235 (0.00%)  1/470 (0.21%) 
Hypoproteinaemia  1  1/235 (0.43%)  0/470 (0.00%) 
Musculoskeletal and connective tissue disorders     
SLE arthritis  1  2/235 (0.85%)  0/470 (0.00%) 
Intervertebral disc protrusion  1  1/235 (0.43%)  0/470 (0.00%) 
Synovial cyst  1  0/235 (0.00%)  1/470 (0.21%) 
Tenosynovitis  1  1/235 (0.43%)  0/470 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine leiomyoma  1  0/235 (0.00%)  2/470 (0.43%) 
Anogenital warts  1  1/235 (0.43%)  0/470 (0.00%) 
Benign breast neoplasm  1  1/235 (0.43%)  0/470 (0.00%) 
Cervix carcinoma  1  0/235 (0.00%)  1/470 (0.21%) 
Ovarian adenoma  1  1/235 (0.43%)  0/470 (0.00%) 
Thyroid adenoma  1  0/235 (0.00%)  1/470 (0.21%) 
Nervous system disorders     
Lupus encephalitis  1  1/235 (0.43%)  1/470 (0.21%) 
Brain stem infarction  1  0/235 (0.00%)  1/470 (0.21%) 
Cerebral infarction  1  0/235 (0.00%)  1/470 (0.21%) 
Dysarthria  1  1/235 (0.43%)  0/470 (0.00%) 
Epilepsy  1  1/235 (0.43%)  0/470 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Ectopic pregnancy  1  0/235 (0.00%)  1/470 (0.21%) 
Psychiatric disorders     
Acute psychosis  1  0/235 (0.00%)  1/470 (0.21%) 
Suicidal ideation  1  0/235 (0.00%)  1/470 (0.21%) 
Suicide attempt  1  1/235 (0.43%)  0/470 (0.00%) 
Renal and urinary disorders     
Lupus nephritis  1  5/235 (2.13%)  5/470 (1.06%) 
Proteinuria  1  2/235 (0.85%)  0/470 (0.00%) 
Renal failure  1  0/235 (0.00%)  2/470 (0.43%) 
Haematuria  1  0/235 (0.00%)  1/470 (0.21%) 
Hydronephrosis  1  1/235 (0.43%)  0/470 (0.00%) 
Lupus cystitis  1  0/235 (0.00%)  1/470 (0.21%) 
Ureteric stenosis  1  1/235 (0.43%)  0/470 (0.00%) 
Reproductive system and breast disorders     
Metrorrhagia  1  0/235 (0.00%)  1/470 (0.21%) 
Respiratory, thoracic and mediastinal disorders     
Interstitial lung disease  1  1/235 (0.43%)  0/470 (0.00%) 
Lupus pleurisy  1  1/235 (0.43%)  0/470 (0.00%) 
Lupus pneumonitis  1  0/235 (0.00%)  1/470 (0.21%) 
Pulmonary hypertension  1  0/235 (0.00%)  1/470 (0.21%) 
Respiratory failure  1  1/235 (0.43%)  0/470 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic  1  0/235 (0.00%)  1/470 (0.21%) 
Erythema multiforme  1  1/235 (0.43%)  0/470 (0.00%) 
Systemic lupus erythematosus rash  1  1/235 (0.43%)  0/470 (0.00%) 
Vascular disorders     
Arterial rupture  1  1/235 (0.43%)  0/470 (0.00%) 
Deep vein thrombosis  1  0/235 (0.00%)  1/470 (0.21%) 
Lupus vasculitis  1  0/235 (0.00%)  1/470 (0.21%) 
Necrosis ischaemic  1  0/235 (0.00%)  1/470 (0.21%) 
Phlebitis  1  1/235 (0.43%)  0/470 (0.00%) 
Varicose vein  1  1/235 (0.43%)  0/470 (0.00%) 
Vasculitis  1  1/235 (0.43%)  0/470 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   108/235 (45.96%)   207/470 (44.04%) 
Gastrointestinal disorders     
Diarrhoea  1  14/235 (5.96%)  28/470 (5.96%) 
General disorders     
Pyrexia  1  17/235 (7.23%)  28/470 (5.96%) 
Infections and infestations     
Upper respiratory tract infection  1  39/235 (16.60%)  65/470 (13.83%) 
Nasopharyngitis  1  26/235 (11.06%)  56/470 (11.91%) 
Viral upper respiratory tract infection  1  15/235 (6.38%)  33/470 (7.02%) 
Upper respiratory tract infection bacterial  1  12/235 (5.11%)  16/470 (3.40%) 
Nervous system disorders     
Headache  1  16/235 (6.81%)  23/470 (4.89%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  16/235 (6.81%)  30/470 (6.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01345253     History of Changes
Other Study ID Numbers: 113750
First Submitted: April 28, 2011
First Posted: May 2, 2011
Results First Submitted: June 9, 2016
Results First Posted: December 2, 2016
Last Update Posted: November 8, 2018