Trial · NCT01484496
A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
NCT01484496, Phase 3, Completed, Human Genome Sciences Inc., a GSK Company; results first posted 2017-07-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE). Trials, record NCT01484496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01484496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
- NCT number
- NCT01484496
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 839 participants, actual
- Lead sponsor
- Human Genome Sciences Inc., a GSK Company
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo, Belimumab 200 mg SC, Standard therapy
- First posted
- 2011-12-02
- Last updated
- 2018-06-06
- Results first posted
- 2017-07-25
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 | Week 52 | 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 (\<=9 vs. \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other). |
| Secondary | Time to First Severe Flare (as Measured by the Modified SLE Flare Index) | Baseline (Day 0, prior to dosing) to Week 52 | Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to \>12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered. |
| Secondary | Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline | Baseline (Day 0, prior to dosing), Weeks 40 through Week 52 | For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by \>=25% from Baseline to \<=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (\<=9 vs \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 | Week 52 | Intention-To-Treat (ITT) Population: comprised of all par. who were randomized and treated with at least one dose of study treatment. Three par. did not have a Baseline PGA assessment; therefore, were not included. | Percentage of par. | NUMBER |
| SECONDARY | Time to First Severe Flare (as Measured by the Modified SLE Flare Index) | Baseline (Day 0, prior to dosing) to Week 52 | ITT population. Only those participants available at that particular timepoints were analyzed. | Days | MEDIAN |
| SECONDARY | Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline | Baseline (Day 0, prior to dosing), Weeks 40 through Week 52 | ITT population. Only par. with Baseline prednisone dose \>7.5 mg/day were included. | Percentage of par. | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 | Placebo SC | 48.4 | Percentage of par. | ||
| Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52 | Belimumab 200 mg SC | 61.4 | Percentage of par. | ||
| Time to First Severe Flare (as Measured by the Modified SLE Flare Index) | Placebo SC | 118 | Full Range 2 to 364 | Days | |
| Time to First Severe Flare (as Measured by the Modified SLE Flare Index) | Belimumab 200 mg SC | 171 | Full Range 5 to 358 | Days | |
| Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline | Placebo SC | 11.9 | Percentage of par. | ||
| Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline | Belimumab 200 mg SC | 18.2 | Percentage of par. |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Placebo SC | 280 | |
| Period 1 | STARTED | Belimumab 200 mg SC | 556 | |
| Period 1 | STARTED | Open-Label - Placebo SC to Belimumab 200 mg SC | 0 | |
| Period 1 | STARTED | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC | 0 | |
| Period 1 | COMPLETED | Placebo SC | 214 | |
| Period 1 | COMPLETED | Belimumab 200 mg SC | 463 | |
| Period 1 | COMPLETED | Open-Label - Placebo SC to Belimumab 200 mg SC | 0 | |
| Period 1 | COMPLETED | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC | 0 | |
| Period 1 | NOT COMPLETED | Placebo SC | 66 | |
| Period 1 | NOT COMPLETED | Belimumab 200 mg SC | 93 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events672
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 | Viral upper respiratory tract infection | Infections and infestations | Placebo SC | 24 | 280 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Belimumab 200 mg SC | 48 | 556 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Open-Label - Placebo SC to Belimumab 200 mg SC | 9 | 206 | |
| other | Viral upper respiratory tract infection | Infections and infestations | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC | 17 | 456 | |
| other | Nasopharyngitis | Infections and infestations | Placebo SC | 22 | 280 | |
| other | Nasopharyngitis | Infections and infestations | Belimumab 200 mg SC | 38 | 556 | |
| other | Nasopharyngitis | Infections and infestations | Open-Label - Placebo SC to Belimumab 200 mg SC | 9 | 206 | |
| other | Nasopharyngitis | Infections and infestations | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC | 7 | 456 | |
| other | Urinary tract infection bacterial | Infections and infestations | Placebo SC | 18 | 280 | |
| other | Urinary tract infection bacterial | Infections and infestations | Belimumab 200 mg SC | 41 | 556 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo SC | 2 | 280 |
| Total, all-cause mortality | Belimumab 200 mg SC | 3 | 556 |
| Total, all-cause mortality | Open-Label - Placebo SC to Belimumab 200 mg SC | 0 | 206 |
| Total, all-cause mortality | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC | 0 | 456 |
| Total, other adverse events | Placebo SC | 218 | 280 |
| Total, other adverse events | Belimumab 200 mg SC | 403 | 556 |
| Total, other adverse events | Open-Label - Placebo SC to Belimumab 200 mg SC | 42 | 206 |
| Total, other adverse events | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC | 78 | 456 |
| Total, serious adverse events | Placebo SC | 44 | 280 |
| Total, serious adverse events | Belimumab 200 mg SC | 60 | 556 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers13
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01484496
GET https://conductscience.org/api/trials/v1/NCT01484496/flow?page=2