Trial · NCT00424476
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00424476, Phase 3, Completed, Human Genome Sciences Inc.; results first posted 2011-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE). Trials, record NCT00424476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424476
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
- NCT number
- NCT00424476
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 865 participants, actual
- Lead sponsor
- Human Genome Sciences Inc.
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo, Belimumab 1 mg/kg, Belimumab 10 mg/kg
- First posted
- 2007-01-19
- Last updated
- 2016-12-12
- Results first posted
- 2011-05-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | SLE Responder Index (SRI) Response Rate at Week 52 | Baseline, 52 weeks | Percentage of subjects with a ≥ 4 point reduction from baseline in SELENA SLEDAI score, and no worsening (increase of \< 0.30 points from baseline) in PGA, and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with baseline. SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores \> 20 are rare. PGA is a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe). BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). |
| Secondary | Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. | Baseline, 52 weeks | |
| Secondary | Mean Change in Physician's Global Assessment (PGA) at Wk 24. | Baseline, 24 weeks | The PGA is a visual analog scale scored from 0 to 3. A score of 1 corresponds to mild lupus disease activity. A score of 2 correlates with moderate disease activity and a score of 3 with severe disease activity. |
| Secondary | Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24. | Baseline, 24 weeks | The SF-36 is a generic health related quality of life (HRQOL) measurement. The survey includes 36 questions grouped to 8 domains and 2 summary measures (physical and mental health component, PCS and MCS, respectively) assessing HRQOL. Responses are scored according to the SF-36v2™ manual. A score is calculated for each SF-36 domain based on the patient's response to each question within it. This is then transformed to a scale ranging from 0 (worst) to 100 (best) points. The PCS is norm-based where the mean=50 and standard deviation (SD)=10. Higher scores represent better physical health. |
| Secondary | Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 | Baseline, Weeks 40 through 52 | |
| Other | Adverse Events (AE) Overview | Up to 56 Weeks | SEE ALSO ADVERSE EVENTS RESULTS SECTION |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | SLE Responder Index (SRI) Response Rate at Week 52 | Baseline, 52 weeks | Analysis was performed on a modified intention-to-treat (MITT) population, defined as all subjects who were randomized and received at least 1 dose of study agent. Subjects who required rescue SLE medications were declared nonresponders, as were subjects who dropped out or were missing Week 52 data. | Percentage of participants | NUMBER |
| SECONDARY | Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. | Baseline, 52 weeks | Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. | Percentage of participants | NUMBER |
| SECONDARY | Mean Change in Physician's Global Assessment (PGA) at Wk 24. | Baseline, 24 weeks | Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. | Scores on a 3-point scale | MEAN |
| SECONDARY | Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24. | Baseline, 24 weeks | Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. | Scores on a scale | MEAN |
| SECONDARY | Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 | Baseline, Weeks 40 through 52 | Analysis was performed on a MITT population, defined as all subjects who were randomized and received at least 1 dose of study agent. Includes only subjects with baseline prednisone dose \> 7.5 mg/day | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Adverse Events (AE) Overview | Up to 56 Weeks | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| SLE Responder Index (SRI) Response Rate at Week 52 | Placebo | 43.6 | Percentage of participants | ||
| SLE Responder Index (SRI) Response Rate at Week 52 | Belimumab 1 mg/kg | 51.4 | Percentage of participants | ||
| SLE Responder Index (SRI) Response Rate at Week 52 | Belimumab 10 mg/kg | 57.6 | Percentage of participants | ||
| Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. | Placebo | 46.0 | Percentage of participants | ||
| Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. | Belimumab 1 mg/kg | 53.1 | Percentage of participants | ||
| Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Wk 52. | Belimumab 10 mg/kg | 58.3 | Percentage of participants | ||
| Mean Change in Physician's Global Assessment (PGA) at Wk 24. | Placebo | -0.39 | Standard Error 0.03 | Scores on a 3-point scale | |
| Mean Change in Physician's Global Assessment (PGA) at Wk 24. | Belimumab 1 mg/kg | -0.44 | Standard Error 0.03 | Scores on a 3-point scale | |
| Mean Change in Physician's Global Assessment (PGA) at Wk 24. | Belimumab 10 mg/kg | -0.54 | Standard Error 0.03 | Scores on a 3-point scale | |
| Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Wk 24. | Placebo | 3.64 | Standard Error 0.42 | Scores on a scale |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 287 | |
| Overall Study | STARTED | Belimumab 1 mg/kg | 288 | |
| Overall Study | STARTED | Belimumab 10 mg/kg | 290 | |
| Overall Study | COMPLETED | Placebo | 226 | |
| Overall Study | COMPLETED | Belimumab 1 mg/kg | 240 | |
| Overall Study | COMPLETED | Belimumab 10 mg/kg | 241 | |
| Overall Study | NOT COMPLETED | Placebo | 61 | |
| Overall Study | NOT COMPLETED | Belimumab 1 mg/kg | 48 | |
| Overall Study | NOT COMPLETED | Belimumab 10 mg/kg | 49 |
Source ClinicalTrials.gov
Adverse events495
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 | Anaemia | Blood and lymphatic system disorders | Placebo | 13 | 287 | |
| other | Anaemia | Blood and lymphatic system disorders | Belimumab 1 mg/kg | 13 | 288 | |
| other | Anaemia | Blood and lymphatic system disorders | Belimumab 10 mg/kg | 15 | 290 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 18 | 287 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Belimumab 1 mg/kg | 8 | 288 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Belimumab 10 mg/kg | 13 | 290 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 19 | 287 | |
| other | Diarrhoea | Gastrointestinal disorders | Belimumab 1 mg/kg | 28 | 288 | |
| other | Diarrhoea | Gastrointestinal disorders | Belimumab 10 mg/kg | 30 | 290 | |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 15 | 287 |
1 to 10 of 495Source ClinicalTrials.gov
See all 495 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Belimumab 1 mg/kg | ||
| Total, all-cause mortality | Belimumab 10 mg/kg | ||
| Total, other adverse events | Placebo | 222 | 287 |
| Total, other adverse events | Belimumab 1 mg/kg | 219 | 288 |
| Total, other adverse events | Belimumab 10 mg/kg | 223 | 290 |
| Total, serious adverse events | Placebo | 36 | 287 |
| Total, serious adverse events | Belimumab 1 mg/kg | 47 | 288 |
| Total, serious adverse events | Belimumab 10 mg/kg | 41 | 290 |
Source ClinicalTrials.gov
Papers21
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/NCT00424476
GET https://conductscience.org/api/trials/v1/NCT00424476/results?page=2