This study will be conducted to evaluate the safety, efficacy and pharmacokinetics of belimumab administered in combination with background standard therapy in pediatric participants with active SLE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Belimumab will be administered.
Standard therapy will be continued.
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changchun, China
GSK Investigational Site
Changsha, China
GSK Investigational Site
Chongqing, China
Number of Participants With Adverse Events of Special Interest (AESIs) Through Week 52
An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AESIs included malignancies, post-infusion systemic or hypersensitivity reactions, infections (including serious infections of special interest), and depression, suicide, or self-injury. Infections of special interest included opportunistic infections (OI), herpes zoster (HZ), tuberculosis (TB), and sepsis. Number of participants with AESIs as identified by custom Medical Dictionary for Regulatory Activities (MedDRA) query has been reported.
Time frame: Up to Week 52
Number of Participants With Greater Than Equal to (>=) 4 Points Reduction From Baseline to Week 52 in Safety of Estrogen in Lupus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) Score
The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Number of participants with a decrease of 4 points or more in the score at Week 52 compared to their Baseline score is presented.
Time frame: Baseline (Day 0) and Week 52
Number of Participants With AEs and Serious Adverse Events (SAEs) Through Week 52
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly, or other situations as per the medical or scientific judgment of the investigator. Number of participants with AEs and SAEs has been reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Hangzhou, China
GSK Investigational Site
Nanjing, China
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Suzhou, China
GSK Investigational Site
Xi'an, China
Time frame: Up to Week 52
Percentage of Participants With >=4 Points Reduction From Baseline in SELENA-SLEDAI Score by Each Visit
The SELENA-SLEDAI score is a cumulative and weighted index for assessing SLE disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Percentage of participants with a decrease of 4 points or more in the score at each visit compared to their Baseline score is presented.
Time frame: Baseline (Day 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline to Week 52 in Physician Global Assessment (PGA)
The PGA is used to assess the participant's current disease activity by investigator. It is collected on a 10 centimeter (cm) visual analogue scale. The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 0) and Week 52
Change From Baseline to Week 52 in Parent Global Assessment (ParentGA)
The ParentGA is used to assess the participant's overall well-being at the moment rated on a 21-numbered circle visual analog scale by the parent. The score ranges from 0 (very well) to 10 (very poorly). Higher score indicates worse effect of the illness on the child. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: Baseline (Day 0) and Week 52
Change From Baseline in Average Daily Prednisone Equivalent Dose at Week 52
The average daily prednisone equivalent dose accounted for all steroids taken IV, intramuscularly (IM), subcutaneously (SC), intradermally, and orally for both SLE and non-SLE reasons. All steroid dosages were converted to a prednisone equivalent in mg at each visit. The daily prednisone equivalent dose for a steroid was calculated as follows: collected dose of the steroid in mg multiplied by (\*) conversion factor \* frequency factor. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. At Baseline, the average daily prednisone equivalent dose was the sum of all prednisone doses over 7 consecutive days up to but not including Day 0, divided by 7. The average daily prednisone dose at Week 52 visit was the sum of all prednisone doses over 7 consecutive days up to and including the Week 52 visit, divided by 7. Average daily prednisone equivalent dose was expressed in milligrams per day.
Time frame: Baseline (Day 0) and Week 52
Time to First Flare Over 52 Weeks
The SLE flare index (SFI) is used to categorize SLE flares as mild/moderate or severe. A mild/moderate SFI flare involves: a SELENA-SLEDAI score increase of 3 to 12 points (higher score means greater disease activity); SLE symptom development; prednisone dose increase (but not above 0.5 milligrams per kilogram per day \[mg/kg/day\]); non-steroidal anti-inflammatory drugs (NSAIDs)/hydroxychloroquine addition; or PGA score increase by 1 or more, but not to more than 2.5 (higher score means greater disease activity). A severe SFI flare involves: SELENA-SLEDAI score increase over 12 points; onset or worsening of severe SLE symptoms; prednisone dose increase above 0.5 mg/kg/day; introduction of potent immunosuppressants; hospitalization; or PGA score reaching 2.5 or higher. Time to first SLE flare (mild/moderate or severe) was the number of days from treatment start date until the participant met an event. Time to first flare was defined as event date minus treatment start date plus 1.
Time frame: Up to Week 52
Time to First Severe Flare Over 52 Weeks
The SFI is used to categorize SLE flares as mild/moderate or severe. A severe SFI flare involves SELENA-SLEDAI score increase over 12 points (higher score means greater disease activity), onset or worsening of severe SLE symptoms, prednisone dose increase above 0.5 mg/kg/day, introduction of potent immunosuppressants, hospitalization, or PGA score reaching 2.5 or higher (higher score means higher disease activity). Time to first severe SLE flare was the number of days from treatment start date until the participant met an event. Time to first severe flare was defined as event date minus treatment start date plus 1.
Time frame: Up to Week 52
Median Belimumab Concentration Levels at Day 0, 7, and 14 Days Post First Dose, and Pre-infusion and Post-infusion at Day 84
Blood samples were collected at indicated time points for measurement of plasma concentrations of belimumab.
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Apparent Total Clearance of Belimumab
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Volume of Distribution of Belimumab
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Terminal Half-life (t1/2) of Belimumab
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Estimated Maximum Concentration (Cmax) of Belimumab at Steady State
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Estimated Minimum Concentration (Cmin) of Belimumab at Steady State
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Estimated Average Concentration (Cavg) of Belimumab at Steady State
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84
Area Under Plasma Concentration-time Curve (AUC) of Belimumab at Steady State
Time frame: Days 0, 7, and 14 days post first dose, and pre-infusion and post-infusion at Day 84