Trial · NCT01705977
Belimumab Assessment of Safety in SLE
NCT01705977, Phase 4, Completed, GlaxoSmithKline; results first posted 2019-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Belimumab Assessment of Safety in SLE. Trials, record NCT01705977. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01705977
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Belimumab Assessment of Safety in SLE
- NCT number
- NCT01705977
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 4,019 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
- First posted
- 2012-10-15
- Last updated
- 2024-07-15
- Other registries' IDs
- eudract:2011-005667-25
- Results first posted
- 2019-11-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Deaths - On Treatment Period (Week 52) | Up to Week 52 (On-treatment period) | Number of participants who died during on-treatment period (Week 52) is reported. The on-treatment period was defined as first dose to last dose + 28 days (or death). The As-Treated Population was defined as all participants who were randomized and received at least one dose of study agent,grouped according to the actual treatment administered for the majority (greater than \[\>\]50 percent \[%\]) of the time. The on-treatment period was the primary analysis period for safety analyses. |
| Primary | Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Up to Week 52 (On-treatment period) | A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), non-melanoma skin cancer (NMSC), malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using Columbia-Suicide Severity Rating Scale \[C-SSRS\]) and serious infusion and hypersensitivity reactions (SIHR) is reported. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death). The on-treatment period was the primary analysis period for safety analyses. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52) | Up to Week 52 (On-treatment period) | An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses. |
| Secondary | Number of Deaths Reported - On-study Period (Week 52) | Up to Week 52 (On-study period) | Number of participants who died during on-study period (Week 52) is reported. The on-study period (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis. |
| Secondary | Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52) | Up to Week 52 (On-study period) | A summary of protocol defined AESIs including serious infections, opportunistic infections and other infections of interest (serious and non-serious), NMSC, malignancies (excluding NMSC), psychiatric events suggesting serious mood disorders and anxiety (serious depression), suicidality (using C-SSRS) and SIHR is reported. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death). The on-study period was a supportive analysis period for safety analysis. |
| Secondary | Number of Participants With SAEs Reported During On-study Period (Week 52) | Up to Week 52 (On-study period) | A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-study period (Week 52) (which includes on and off treatment data) was defined as first dose to the end of the Week 52 study follow-up (or death) and was a supportive analysis period for safety analyses. |
| Secondary | Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 | Week 40 to Week 52 | The average daily prednisone dose during Weeks 40 to 52 is the sum of all prednisone doses to treat SLE from the day following the Week 40 visit date up to but not including the Week 52 study completion date divided by the number of days between Week 40 visit date and study completion date (study completion date - Week 40 visit date). Percentage of participants whose average prednisone dose has been reduced by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52 in participants with average prednisone use greater than 7.5 mg/day at Baseline was compared between belimumab and placebo using a logistic regression model including treatment group, Baseline prednisone dose, screening safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score (\<=9 versus \>=10) and region. Baseline is defined as the last available value measured prior to dosing on or before the date of first dose (Day 1). |
| Secondary | Number of Participants With All-cause Mortality During Years 2 to 5 | From 2 years to 5 years | Number of participants with all-cause mortality during years 2 to 5 has been presented. |
| Secondary | Number of Participants With New Primary Malignancies During Years 2 to 5 | From 2 years to 5 years | Number of participants with new primary malignancies during years 2 to 5 has been presented. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Deaths - On Treatment Period (Week 52) | Up to Week 52 (On-treatment period) | As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Up to Week 52 (On-treatment period) | As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52) | Up to Week 52 (On-treatment period) | As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Deaths Reported - On-study Period (Week 52) | Up to Week 52 (On-study period) | As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Reported Protocol Defined AESI: On-study Period (Week 52) | Up to Week 52 (On-study period) | As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With SAEs Reported During On-study Period (Week 52) | Up to Week 52 (On-study period) | As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Whose Average Prednisone (or Equivalent) Dose to Treat SLE Has Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 | Week 40 to Week 52 | ITT Population. Only those participants with Baseline prednisone\>7.5 mg/day were analyzed. The ITT population is defined as all participants who were randomized and received at least one dose of study agent and the analysis was performed per the treatment that a participant was randomized to receive, regardless of the actual treatment received. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants With All-cause Mortality During Years 2 to 5 | From 2 years to 5 years | As-Treated Any Year 2-5 Follow-up Population consisted of all participants in the As-Treated population who completed at least one post-treatment follow-up visit for Year 2 to 5. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New Primary Malignancies During Years 2 to 5 | From 2 years to 5 years | As-Treated Any Year 2-5 Follow-up Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Deaths - On Treatment Period (Week 52) | Placebo | 8 | Participants | ||
| Number of Deaths - On Treatment Period (Week 52) | Belimumab 10 mg/kg | 10 | Participants | ||
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Placebo | Serious Infections, n=2001, 2002 | 82 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Belimumab 10 mg/kg | Serious Infections, n=2001, 2002 | 75 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Placebo | Opportunistic Infections and Other Infections of Interest, n=2001, 2002 | 50 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Belimumab 10 mg/kg | Opportunistic Infections and Other Infections of Interest, n=2001, 2002 | 36 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Placebo | Malignancies (Excluding NMSC), n=2001, 2002 | 5 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Belimumab 10 mg/kg | Malignancies (Excluding NMSC), n=2001, 2002 | 5 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Placebo | NMSC, n=2001, 2002 | 3 | Participants | |
| Number of Participants Who Reported Protocol Defined Adverse Events of Special Interest (AESI): On-treatment Period (Week 52) | Belimumab 10 mg/kg | NMSC, n=2001, 2002 | 4 | Participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (Year 1) | STARTED | Placebo | 2,009 | |
| Treatment Period (Year 1) | STARTED | Belimumab 10 mg/kg | 2,010 | |
| Treatment Period (Year 1) | Intent-to-Treat Population | Placebo | 2,002 | |
| Treatment Period (Year 1) | Intent-to-Treat Population | Belimumab 10 mg/kg | 2,001 | |
| Treatment Period (Year 1) | COMPLETED | Placebo | 1,729 | |
| Treatment Period (Year 1) | COMPLETED | Belimumab 10 mg/kg | 1,741 | |
| Treatment Period (Year 1) | NOT COMPLETED | Placebo | 280 | |
| Treatment Period (Year 1) | NOT COMPLETED | Belimumab 10 mg/kg | 269 | |
| Follow-up Period (Years 2 to 5) | STARTED | Placebo | 1,670 | |
| Follow-up Period (Years 2 to 5) | STARTED | Belimumab 10 mg/kg | 1,695 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events660
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Herpes zoster | Infections and infestations | Placebo | 31 | 2,001 | 33 |
| other | Herpes zoster | Infections and infestations | Belimumab 10 mg/kg | 17 | 2,002 | 17 |
| serious | Pneumonia | Infections and infestations | Placebo | 27 | 2,001 | 28 |
| serious | Pneumonia | Infections and infestations | Belimumab 10 mg/kg | 18 | 2,002 | 18 |
| serious | Urinary tract infection | Infections and infestations | Placebo | 8 | 2,001 | 9 |
| serious | Urinary tract infection | Infections and infestations | Belimumab 10 mg/kg | 16 | 2,002 | 17 |
| serious | Lupus nephritis | Renal and urinary disorders | Placebo | 11 | 2,001 | 11 |
| serious | Lupus nephritis | Renal and urinary disorders | Belimumab 10 mg/kg | 6 | 2,002 | 6 |
| serious | Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | Placebo | 11 | 2,001 | 12 |
| serious | Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | Belimumab 10 mg/kg | 5 | 2,002 | 6 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 80 | 2,001 |
| Total, all-cause mortality | Belimumab 10 mg/kg | 51 | 2,002 |
| Total, other adverse events | Placebo | 31 | 2,001 |
| Total, other adverse events | Belimumab 10 mg/kg | 17 | 2,002 |
| Total, serious adverse events | Placebo | 241 | 2,001 |
| Total, serious adverse events | Belimumab 10 mg/kg | 233 | 2,002 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38279368 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Belimumab 10 mg/kg vs Placebo: Number of Deaths - On Treatment Period (Week 52) | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: Number of Participants With All-cause Mortality During Years 2 to 5 | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: Number of Participants With New Primary Malignancies During Years 2 to 5 | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52) | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: Number of Deaths Reported - On-study Period (Week 52) | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: Number of Participants With SAEs Reported During On-study Period (Week 52) | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: deaths from any cause | Trial comparisons |
| Belimumab 10 mg/kg vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01705977
GET https://conductscience.org/api/trials/v1/NCT01705977/results?page=2