Arthritis, Rheumatoid
Conditions
Keywords
RA
Brief summary
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).
Detailed description
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.
Interventions
DRUGPlacebo
Placebo IV plus standard therapy (SOC) for RA; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an additional 24 weeks.
Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA; belimumab 4 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate either continued on the same dose of belimumab or may have been switched to belimumab 10 mg/kg at the investigator's discretion for an additional 24 weeks.
Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 24 weeks in the double-blind period. In the open-label extension period, patients who opted to participate continued on the same dose of belimumab (10 mg/kg) for an additional 24 weeks.
Sponsors
Human Genome Sciences Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * Diagnosis of RA for at least 1 year * Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab) * Active RA disease of at least moderate disease activity * Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days Primary
Exclusion criteria
* Received a non-FDA approved investigational agent within the last 28 days * Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra) * Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide * Steroid injection into any joint within the last 30 days * History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency * History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days * Human immunodeficiency virus (HIV), Hepatitis-B, Hepatitis-C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) | Baseline, 24 weeks | An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First ACR70 Response, Based on ESR | 0 to 24 weeks | Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study. |
| Percentage of Patients With an ACR50 Response at Week 24, Based on ESR | Baseline, 24 weeks | An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]). |
| Percentage of Patients With an ACR70 Response at Week 24, Based on ESR | Baseline, 24 weeks | An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]). |
| Time to First ACR20 Response, Based on ESR | 0 to 24 weeks | The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24. |
| Mean Change in Disease Activity Score 28 (DAS28) at Week 24 | Baseline, 24 weeks | DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (\>5.1=active disease; \<3.2=well controlled disease; \<2.6=remission). Change from baseline \>1.2 = good response and ≤0.6 = non-response. |
| Time to First DAS28 Response | 0 to 24 weeks | DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a good or a moderate improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as \>1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and \> 0.6 with a DAS28 score of \> 5.1. |
| Mean Change in Modified Total Sharp Score at Week 24 | Baseline, 24 weeks | The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage. |
| Time to First ACR50 Response, Based on ESR | 0 to 24 weeks | Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) Overview | Up to 56 weeks | Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 48/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBRA99/NCT00583557). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Plus SOC Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study | 69 |
| Belimumab 1 mg/kg Plus SOC Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study | 72 |
| Belimumab 4 mg/kg Plus SOC Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study | 71 |
| Belimumab 10 mg/kg Plus SOC Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study | 71 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 24-Week Double-Blind Period | Adverse Event | 2 | 3 | 4 | 4 |
| 24-Week Double-Blind Period | Lack of Efficacy | 3 | 1 | 2 | 1 |
| 24-Week Double-Blind Period | Lost to Follow-up | 0 | 1 | 1 | 0 |
| 24-Week Double-Blind Period | Protocol Violation | 0 | 0 | 0 | 1 |
| 24-Week Double-Blind Period | Withdrawal by Subject | 5 | 1 | 1 | 5 |
| 24-Week Open-Label Extension Period | Adverse Event | 0 | 0 | 0 | 7 |
| 24-Week Open-Label Extension Period | Lack of Compliance | 0 | 0 | 1 | 2 |
| 24-Week Open-Label Extension Period | Lack of Efficacy | 0 | 0 | 0 | 17 |
| 24-Week Open-Label Extension Period | Lost to Follow-up | 0 | 0 | 0 | 2 |
| 24-Week Open-Label Extension Period | Withdrawal by Subject | 0 | 0 | 0 | 12 |
Baseline characteristics
| Characteristic | Belimumab 1 mg/kg Plus SOC | Placebo Plus SOC | Belimumab 4 mg/kg Plus SOC | Belimumab 10 mg/kg Plus SOC | Total |
|---|---|---|---|---|---|
| Age Continuous | 50.6 years STANDARD_DEVIATION 8.3 | 50.7 years STANDARD_DEVIATION 8.8 | 50.7 years STANDARD_DEVIATION 10.2 | 49.5 years STANDARD_DEVIATION 9.3 | 50.4 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment Poland | 11 participants | 14 participants | 12 participants | 12 participants | 49 participants |
| Region of Enrollment United States | 61 participants | 55 participants | 59 participants | 59 participants | 234 participants |
| Sex: Female, Male Female | 56 Participants | 56 Participants | 60 Participants | 54 Participants | 226 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 11 Participants | 17 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 50 / 69 | 47 / 72 | 48 / 71 | 54 / 71 | 165 / 237 |
| serious Total, serious adverse events | 5 / 69 | 5 / 72 | 5 / 71 | 6 / 71 | 26 / 237 |
Outcome results
Primary
Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)
An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]).
Time frame: Baseline, 24 weeks
Population: Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Plus SOC | Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) | 15.9 percentage of participants |
| Belimumab 1 mg/kg Plus SOC | Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) | 34.7 percentage of participants |
| Belimumab 4 mg/kg Plus SOC | Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) | 25.4 percentage of participants |
| Belimumab 10 mg/kg Plus SOC | Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR) | 28.2 percentage of participants |
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.009795% CI: [4.8, 32.8]Likelihood ratio chi-squared
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.167795% CI: [-3.9, 22.7]Likelihood ratio chi-squared
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.079695% CI: [-1.3, 25.8]Likelihood ratio chi-squared
Secondary
Mean Change in Disease Activity Score 28 (DAS28) at Week 24
DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (\>5.1=active disease; \<3.2=well controlled disease; \<2.6=remission). Change from baseline \>1.2 = good response and ≤0.6 = non-response.
Time frame: Baseline, 24 weeks
Population: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a baseline and a Week 24 DAS28 score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus SOC | Mean Change in Disease Activity Score 28 (DAS28) at Week 24 | -0.9 scores on a scale | Standard Error 0.15 |
| Belimumab 1 mg/kg Plus SOC | Mean Change in Disease Activity Score 28 (DAS28) at Week 24 | -1.3 scores on a scale | Standard Error 0.18 |
| Belimumab 4 mg/kg Plus SOC | Mean Change in Disease Activity Score 28 (DAS28) at Week 24 | -0.9 scores on a scale | Standard Error 0.14 |
| Belimumab 10 mg/kg Plus SOC | Mean Change in Disease Activity Score 28 (DAS28) at Week 24 | -1.5 scores on a scale | Standard Error 0.15 |
Comparison: Missing data was handled by using last observation carried forward (LOCF) imputation.p-value: 0.0958t-test, 2 sided
Comparison: Missing data was handled by using LOCF imputation.p-value: 0.7864t-test, 2 sided
Comparison: Missing data was handled by using LOCF imputation.p-value: 0.0051t-test, 2 sided
Secondary
Mean Change in Modified Total Sharp Score at Week 24
The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.
Time frame: Baseline, 24 weeks
Population: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a modified total Sharp score at baseline and at Week 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Plus SOC | Mean Change in Modified Total Sharp Score at Week 24 | 0.7 scores on a scale | Standard Error 0.2 |
| Belimumab 1 mg/kg Plus SOC | Mean Change in Modified Total Sharp Score at Week 24 | 0.3 scores on a scale | Standard Error 0.2 |
| Belimumab 4 mg/kg Plus SOC | Mean Change in Modified Total Sharp Score at Week 24 | 0.3 scores on a scale | Standard Error 0.2 |
| Belimumab 10 mg/kg Plus SOC | Mean Change in Modified Total Sharp Score at Week 24 | 0.6 scores on a scale | Standard Error 0.2 |
Comparison: Missing data was handled by using LOCF imputation.p-value: 0.194t-test, 2 sided
Comparison: Missing data was handled by using LOCF imputation.p-value: 0.2561t-test, 2 sided
Comparison: Missing data was handled by using LOCF imputation.p-value: 0.8707t-test, 2 sided
Secondary
Percentage of Patients With an ACR50 Response at Week 24, Based on ESR
An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]).
Time frame: Baseline, 24 weeks
Population: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Plus SOC | Percentage of Patients With an ACR50 Response at Week 24, Based on ESR | 4.3 percentage of participants |
| Belimumab 1 mg/kg Plus SOC | Percentage of Patients With an ACR50 Response at Week 24, Based on ESR | 9.7 percentage of participants |
| Belimumab 4 mg/kg Plus SOC | Percentage of Patients With an ACR50 Response at Week 24, Based on ESR | 8.5 percentage of participants |
| Belimumab 10 mg/kg Plus SOC | Percentage of Patients With an ACR50 Response at Week 24, Based on ESR | 14.1 percentage of participants |
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.207495% CI: [-3, 13.7]Likelihood ratio chi-squared
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.317795% CI: [-4, 12.2]Likelihood ratio chi-squared
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.041895% CI: [0.3, 19.2]Likelihood ratio chi-squared
Secondary
Percentage of Patients With an ACR70 Response at Week 24, Based on ESR
An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate \[ESR\]).
Time frame: Baseline, 24 weeks
Population: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Plus SOC | Percentage of Patients With an ACR70 Response at Week 24, Based on ESR | 2.9 percentage of participants |
| Belimumab 1 mg/kg Plus SOC | Percentage of Patients With an ACR70 Response at Week 24, Based on ESR | 5.6 percentage of participants |
| Belimumab 4 mg/kg Plus SOC | Percentage of Patients With an ACR70 Response at Week 24, Based on ESR | 1.4 percentage of participants |
| Belimumab 10 mg/kg Plus SOC | Percentage of Patients With an ACR70 Response at Week 24, Based on ESR | 2.8 percentage of participants |
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.429995% CI: [-4, 9.3]Likelihood ratio chi-squared
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.539395% CI: [-6.3, 3.3]Likelihood ratio chi-squared
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data.p-value: 0.976995% CI: [-5.6, 5.4]Likelihood ratio chi-squared
Secondary
Time to First ACR20 Response, Based on ESR
The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.
Time frame: 0 to 24 weeks
Population: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Plus SOC | Time to First ACR20 Response, Based on ESR | 112 days |
| Belimumab 1 mg/kg Plus SOC | Time to First ACR20 Response, Based on ESR | 109 days |
| Belimumab 4 mg/kg Plus SOC | Time to First ACR20 Response, Based on ESR | 112 days |
| Belimumab 10 mg/kg Plus SOC | Time to First ACR20 Response, Based on ESR | 111 days |
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.p-value: 0.1752Log Rank
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.p-value: 0.344Log Rank
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have any ACR response were censored at the last visit or exit visit, whichever occurred first. Patients who did not have an ACR response and discontinued from the study prior to study completion were censored at the last date on study.p-value: 0.4308Log Rank
Secondary
Time to First ACR50 Response, Based on ESR
Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.
Time frame: 0 to 24 weeks
Secondary
Time to First ACR70 Response, Based on ESR
Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.
Time frame: 0 to 24 weeks
Secondary
Time to First DAS28 Response
DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a good or a moderate improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as \>1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and \> 0.6 with a DAS28 score of \> 5.1.
Time frame: 0 to 24 weeks
Population: Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo Plus SOC | Time to First DAS28 Response | 111 days |
| Belimumab 1 mg/kg Plus SOC | Time to First DAS28 Response | 82 days |
| Belimumab 4 mg/kg Plus SOC | Time to First DAS28 Response | 84 days |
| Belimumab 10 mg/kg Plus SOC | Time to First DAS28 Response | 57 days |
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.p-value: 0.096Log Rank
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.p-value: 0.2859Log Rank
Comparison: Patients who required rescue RA medications were declared nonresponders, as were patients who dropped out or were missing Week 24 data. Patients who did not have good or moderate improvement in DAS28 were censored at the last visit or exit visit, whichever occurred first. Patients who did not have good or moderate improvement in DAS28 and discontinued from the study prior to study completion were censored at the last date on study.p-value: 0.0109Log Rank
Other Pre-specified
Adverse Events (AE) Overview
Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 48/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBRA99/NCT00583557).
Time frame: Up to 56 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 SAE | 7.2 percentage of participants |
| Placebo Plus SOC | Adverse Events (AE) Overview | Percent of patients with an AE resulting in death | 1.5 percentage of participants |
| Placebo Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 AE | 89.9 percentage of participants |
| Belimumab 1 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with an AE resulting in death | 0 percentage of participants |
| Belimumab 1 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 SAE | 6.9 percentage of participants |
| Belimumab 1 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 AE | 84.7 percentage of participants |
| Belimumab 4 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 AE | 90.1 percentage of participants |
| Belimumab 4 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 SAE | 7.0 percentage of participants |
| Belimumab 4 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with an AE resulting in death | 0 percentage of participants |
| Belimumab 10 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 SAE | 8.5 percentage of participants |
| Belimumab 10 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with at least 1 AE | 93.0 percentage of participants |
| Belimumab 10 mg/kg Plus SOC | Adverse Events (AE) Overview | Percent of patients with an AE resulting in death | 1.4 percentage of participants |
| Open-label Extension Period: All Active | Adverse Events (AE) Overview | Percent of patients with at least 1 SAE | 11.0 percentage of participants |
| Open-label Extension Period: All Active | Adverse Events (AE) Overview | Percent of patients with an AE resulting in death | 0 percentage of participants |
| Open-label Extension Period: All Active | Adverse Events (AE) Overview | Percent of patients with at least 1 AE | 91.6 percentage of participants |