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Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO)

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ClinicalTrials.gov Identifier: NCT01649765
Recruitment Status : Active, not recruiting
First Posted : July 25, 2012
Results First Posted : August 15, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
Human Genome Sciences Inc., a GSK Company
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 10mg/kg
Other: placebo
Enrollment 93
Recruitment Details A total of 93 pediatric participants with Systemic Lupus Erythematosus (SLE) were enrolled at 29 study centers in 10 different countries. This was a multi-center study to evaluate the safety, efficacy and pharmacokinetics of belimumab plus background standard therapy. The results presented are based on Part A (double blind).
Pre-assignment Details The study consisted of three separate phases: Randomized, placebo-controlled, double-blind 52-week treatment phase (Part A), Long term belimumab open label safety follow up for participants who completed Part A (Part B) and Long term safety follow-up phase for participants who were withdrawn from Part A or Part B at any time (Part C).
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care. Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Period Title: Overall Study
Started 40 53
Completed 31 45
Not Completed 9 8
Reason Not Completed
Adverse Event             5             3
Lack of Efficacy             1             1
Physician Decision             0             3
Protocol Violation             1             0
Withdrawal by Subject             2             1
Arm/Group Title Placebo Belimumab 10 mg/kg Total
Hide Arm/Group Description Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care. Total of all reporting groups
Overall Number of Baseline Participants 40 53 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 53 participants 93 participants
14.8  (2.17) 13.5  (2.59) 14.0  (2.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 53 participants 93 participants
Female
39
  97.5%
49
  92.5%
88
  94.6%
Male
1
   2.5%
4
   7.5%
5
   5.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race customized Number Analyzed 40 participants 53 participants 93 participants
White - White/Caucasian/European Heritage
21
  52.5%
27
  50.9%
48
  51.6%
Asian
6
  15.0%
8
  15.1%
14
  15.1%
African American/African Heritage
2
   5.0%
3
   5.7%
5
   5.4%
American Indian or Alaskan Native
11
  27.5%
15
  28.3%
26
  28.0%
1.Primary Outcome
Title Percentage of Participants With SLE Responder Index (SRI) Response at Week 52
Hide Description SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=12 vs. >=13). Percentage of participants with SRI response at Week 52 of Part A were reported. Intent-to-Treat Population comprised of all participants who were randomized and treated with at least one dose of study agent in Part A. One participant had missing data at Baseline and therefore, could not be included in the analysis.
Time Frame Week 52
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Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 39 53
Measure Type: Number
Unit of Measure: Percentage of participants
43.6 52.8
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
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
0.64 to 3.46
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Meeting Pediatric Rheumatology International Trials Organization (PRINTO)/ American College of Rheumatology (ACR) Juvenile SLE Response Evaluation Criteria for Improvement in Juvenile SLE at Week 52 Using Definition 1 and 2
Hide Description Percentage of participants meeting PRINTO/ACR Juvenile SLE Response Evaluation criteria for improvement in juvenile SLE using two different PRINTO/ACR Juvenile SLE Response Evaluation definitions of improvement that is Definition 1: At least 50% improvement in any 2 of 5 endpoints below and no more than 1 of the remaining worsening by more than 30% and Definition 2: At least 30% improvement in 3 of 5 endpoints below and no more than 1 of the remaining worsening more than 30%. Endpoints were: 1. Percent change in Parent’s Global Assessment (ParentGA) at Week 52, 2. Percent change in PGA at Week 52, 3. Percent change in SELENA SLEDAI score at Week 52, 4. Percent change in Pediatric Quality of Life Inventory (PedsQL) physical functioning domain at Week 52, 5. Percent change in 24 hour proteinuria at Week 52 (gram/24hour equivalent by spot urine protein to creatinine ratio).
Time Frame Week 52
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Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 40 53
Measure Type: Number
Unit of Measure: Percentage of participants
Definition 1 35.0 60.4
Definition 2 27.5 52.8
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
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
1.15 to 6.54
Estimation Comments Definition 1
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Belimumab 10 mg/kg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.92
Confidence Interval (2-Sided) 95%
1.19 to 7.17
Estimation Comments Definition 2
3.Secondary Outcome
Title Percent Change From Baseline in ParentGA at Week 52
Hide Description ParentGA assesses the participant’s overall well-being at the moment rated on a 21-numbered circle visual analog scale (VAS; 0 - very well, 10 - very poorly). Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. Last Observation Carried Forward (LOCF) was used. Eight participants had a score of zero at Baseline and therefore, could not be included in the analysis.
Time Frame Baseline (Day 0) and Week 52
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Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 38 47
Median (Full Range)
Unit of Measure: Percent change
-23.61
(-95.0 to 600.0)
-53.85
(-100.0 to 900.0)
4.Secondary Outcome
Title Percent Change From Baseline in PGA at Week 52
Hide Description The PGA is a 10 centimeter (cm) visual analogue scale (VAS), anchored at 0 (none) and 3 (severe), designed for the physician to indicate the participant's overall disease activity at a particular visit as part of the validated SELENA SLEDAI index. Primary investigator or a subinvestigator scored the PGA for the participant, and same person evaluated the participant each time. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. LOCF was used.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 40 53
Mean (Standard Deviation)
Unit of Measure: Percent change
-48.802  (42.0423) -56.525  (43.7939)
5.Secondary Outcome
Title Percent Change From Baseline in SELENA SLEDAI 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. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline value X 100. One participant had missing data at Baseline and therefore, could not be included in the analysis.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 39 53
Mean (Standard Deviation)
Unit of Measure: Percent change
-38.0  (39.50) -43.3  (43.73)
6.Secondary Outcome
Title Percent Change From Baseline in PedsQL Physical Functioning Domain Score at Week 52
Hide Description The PedsQL is a generic quality of life scale validated for the pediatric population which consists of 23 items, encompassing 4 health domains: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). From the raw scores of the 23 items, a total summary score and individual domain scores can be calculated. The total and domain scores are each transformed on a 0 to 100 score with higher scores indicating higher quality of life. For Physical Functioning Domain scale, score was from 0 to 100 where, 0 indicates lower quality of life and 100 indicates greater quality of life. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 40 53
Median (Full Range)
Unit of Measure: Percent change
12.5
(-53 to 575)
10.5
(-100 to 280)
7.Secondary Outcome
Title Percent Change From Baseline in Proteinuria at Week 52
Hide Description Percent change from Baseline in proteinuria was calculated. The percent change from baseline to Week 52 in 24 hour proteinuria was analyzed using summary statistics and 95% confidence intervals, without any adjustment for covariates. Baseline was defined as measurements at Day 0. Percent change from Baseline was calculated by subtracting the Baseline value from value at Week 52 divided by the Baseline Value X 100. LOCF was used.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 40 53
Median (Full Range)
Unit of Measure: Percent Change
7.0920
(-90.568 to 570.149)
-2.1277
(-85.073 to 1681.884)
8.Secondary Outcome
Title Percentage of Participants With a Sustained SRI Response
Hide Description Sustained SRI response was defined as having a response on the primary efficacy endpoint at Weeks 44, 48, and 52. Data for percentage of participants with a sustained SRI response was presented. Drop Outs and Treatment Failures were considered Non-Responders. Only those participants with data available at specific time point were analyzed.
Time Frame Up to 52 weeks
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Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 39 53
Measure Type: Number
Unit of Measure: Percentage of participants
41.0 43.4
9.Secondary Outcome
Title Percentage of Participants With a Sustained ParentGA Response
Hide Description Sustained ParentGA response was defined as having >0.7 improvement at Weeks 44, 48, and 52 compared at Baseline. Data for percentage of participants with a sustained ParentGA response was presented. Thirteen participants had a score of <=0.7 at Baseline and therefore, could not be included in the analysis.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 36 44
Measure Type: Number
Unit of Measure: Percentage of Participants
33.3 59.1
10.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation participant, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Number of participants with AEs and SAEs have been reported.
Time Frame Up to 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care.
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 40 53
Measure Type: Count of Participants
Unit of Measure: Participants
AEs
33
  82.5%
42
  79.2%
SAEs
14
  35.0%
9
  17.0%
11.Secondary Outcome
Title Maximum Concentration at Steady State (Cmax, ss) and Minimum Concentration at Steady State (Cmin, ss)
Hide Description The pharmacokinetic (PK) population comprised all participants included in the As- Treated population for whom at least one post belimumab treatment PK sample was obtained and analyzed. The PK model was fitted to the observed serum concentration-time data. The maximum (Cmax) and minimum (Cmin) concentrations reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.
Time Frame 28-days dosing interval at steady state
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Hide Analysis Population Description
PK Population
Arm/Group Title Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
Cmax, ss
315
(31.2%)
Cmin, ss
50
(68.3%)
12.Secondary Outcome
Title Area Under Curve of Belimumab at Steady State (AUC, ss)
Hide Description The PK model was fitted to the observed serum concentration-time data. The AUC values reported in this table are model derived values at ss, assuming a 10 mg/kg dose administered once every 28 days.
Time Frame 28-days dosing interval at steady state
Hide Outcome Measure Data
Hide Analysis Population Description
PK Population
Arm/Group Title Belimumab 10 mg/kg
Hide Arm/Group Description:
Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
Overall Number of Participants Analyzed 53
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Micrograms per milliliter
3012
(43.2%)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from start of the study to the follow up visit (Up to 60 weeks).
Adverse Event Reporting Description Intent-to-Treat Population was used to collect adverse events.
 
Arm/Group Title Placebo Belimumab 10 mg/kg
Hide Arm/Group Description Participants received saline infusion (placebo) intravenously monthly for 48 weeks on a background of standard of care Participants received 10 milligrams per kilograms (mg/kg) reconstituted solution intravenously monthly for 48 weeks on a background of standard of care.
All-Cause Mortality
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/40 (2.50%)      0/53 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Belimumab 10 mg/kg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/40 (35.00%)      9/53 (16.98%)    
Blood and lymphatic system disorders     
Anaemia  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Thrombocytopenia  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Cardiac disorders     
Pericardial effusion  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Eye disorders     
Eye swelling  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Retinal vasculitis  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Gastrointestinal disorders     
Pancreatitis acute  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Vasculitis gastrointestinal  1  0/40 (0.00%)  0 1/53 (1.89%)  2
Vomiting  1  1/40 (2.50%)  1 0/53 (0.00%)  0
General disorders     
Chest pain  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Pyrexia  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Hepatobiliary disorders     
Hypertransaminasaemia  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Infections and infestations     
Herpes zoster  1  1/40 (2.50%)  1 1/53 (1.89%)  1
Abscess limb  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Epiglottitis  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Gastroenteritis  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Hepatitis A  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Influenza  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Pneumonia  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Vulval abscess  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Injury, poisoning and procedural complications     
Ligament sprain  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Metabolism and nutrition disorders     
Fluid overload  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteochondrosis  1  1/40 (2.50%)  1 0/53 (0.00%)  0
SLE arthritis  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Systemic lupus erythematosus  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Nervous system disorders     
Headache  1  2/40 (5.00%)  2 0/53 (0.00%)  0
Idiopathic intracranial hypertension  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Post herpetic neuralgia  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Psychiatric disorders     
Major depression  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Suicidal ideation  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Suicide attempt  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Renal and urinary disorders     
Lupus nephritis  1  2/40 (5.00%)  2 2/53 (3.77%)  2
Glomerulonephritis  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  1  1/40 (2.50%)  1 0/53 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  0/40 (0.00%)  0 1/53 (1.89%)  1
Skin lesion  1  0/40 (0.00%)  0 1/53 (1.89%)  1
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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 (%) # Events Affected / at Risk (%) # Events
Total   27/40 (67.50%)      36/53 (67.92%)    
Blood and lymphatic system disorders     
Leukopenia  1  3/40 (7.50%)  3 2/53 (3.77%)  2
Neutropenia  1  1/40 (2.50%)  1 3/53 (5.66%)  4
Anaemia  1  3/40 (7.50%)  3 0/53 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea  1  3/40 (7.50%)  5 7/53 (13.21%)  9
Nausea  1  3/40 (7.50%)  4 5/53 (9.43%)  6
Abdominal pain  1  3/40 (7.50%)  3 3/53 (5.66%)  4
Vomiting  1  3/40 (7.50%)  4 2/53 (3.77%)  2
Dyspepsia  1  3/40 (7.50%)  4 1/53 (1.89%)  1
General disorders     
Chest pain  1  4/40 (10.00%)  5 4/53 (7.55%)  4
Pyrexia  1  3/40 (7.50%)  10 2/53 (3.77%)  2
Fatigue  1  2/40 (5.00%)  4 1/53 (1.89%)  2
Infections and infestations     
Nasopharyngitis  1  8/40 (20.00%)  11 9/53 (16.98%)  14
Upper respiratory tract infection  1  8/40 (20.00%)  8 6/53 (11.32%)  8
Herpes zoster  1  2/40 (5.00%)  2 4/53 (7.55%)  6
Pharyngitis  1  3/40 (7.50%)  3 3/53 (5.66%)  4
Gastroenteritis  1  3/40 (7.50%)  3 2/53 (3.77%)  3
Urinary tract infection  1  4/40 (10.00%)  8 1/53 (1.89%)  2
Bronchitis  1  2/40 (5.00%)  2 1/53 (1.89%)  1
Conjunctivitis  1  2/40 (5.00%)  4 0/53 (0.00%)  0
Influenza  1  2/40 (5.00%)  2 0/53 (0.00%)  0
Investigations     
Transaminases increased  1  1/40 (2.50%)  1 3/53 (5.66%)  3
Blood immunoglobulin G decreased  1  2/40 (5.00%)  2 1/53 (1.89%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/40 (10.00%)  10 3/53 (5.66%)  4
Back pain  1  3/40 (7.50%)  4 2/53 (3.77%)  3
Pain in extremity  1  2/40 (5.00%)  2 2/53 (3.77%)  3
Joint swelling  1  2/40 (5.00%)  2 0/53 (0.00%)  0
Nervous system disorders     
Headache  1  10/40 (25.00%)  17 7/53 (13.21%)  9
Psychiatric disorders     
Insomnia  1  3/40 (7.50%)  3 0/53 (0.00%)  0
Suicidal ideation  1  2/40 (5.00%)  3 0/53 (0.00%)  0
Renal and urinary disorders     
Lupus nephritis  1  2/40 (5.00%)  2 1/53 (1.89%)  1
Reproductive system and breast disorders     
Menorrhagia  1  2/40 (5.00%)  2 1/53 (1.89%)  1
Dysmenorrhoea  1  2/40 (5.00%)  5 0/53 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  3/40 (7.50%)  3 4/53 (7.55%)  4
Cough  1  3/40 (7.50%)  3 3/53 (5.66%)  4
Oropharyngeal pain  1  2/40 (5.00%)  2 3/53 (5.66%)  3
Dyspnoea  1  2/40 (5.00%)  2 0/53 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  1/40 (2.50%)  1 3/53 (5.66%)  3
Vascular disorders     
Hypertension  1  2/40 (5.00%)  2 0/53 (0.00%)  0
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01649765     History of Changes
Other Study ID Numbers: 114055
First Submitted: July 23, 2012
First Posted: July 25, 2012
Results First Submitted: July 23, 2018
Results First Posted: August 15, 2018
Last Update Posted: September 3, 2018