Trial · NCT01632241
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
NCT01632241, Phase 4, Completed, Human Genome Sciences Inc., a GSK Company; results first posted 2019-07-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE). Trials, record NCT01632241. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01632241
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
- NCT number
- NCT01632241
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 503 participants, actual
- Lead sponsor
- Human Genome Sciences Inc., a GSK Company
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
- First posted
- 2012-07-02
- Last updated
- 2021-09-08
- Other registries' IDs
- eudract:2011-005672-42
- Results first posted
- 2019-07-05
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase] | Week 52 | SRI response is defined as \>=4 point reduction, from Baseline in safety of estrogen in Lupus National Assessment(SELENA)SLEDAI\[SS\] score (with modified SLEDAI-2K scoring for proteinuria \[PU\]), 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 \[ODS\] or 2 new BILAG B ODS compared with Baseline. Drop-outs and treatment failures were set to non-responders. Analysis performed using a logistic regression model for comparison between belimumab and placebo with covariates treatment group, Baseline SS score (with modified SLEDAI-2K scoring for PU) (\<=9 versus \[vs.\] \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (United States \[US\]/Canada vs. Rest of World). The Modified Intention-To-Treat (mITT) population comprised of safety population excluding participants who had any assessment at 3 sites (202196, 202513 or 107286). |
| Primary | Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase | Week 24 of OL phase (Week 76) | SRI response is defined as \>=4 point reduction, from OL Baseline in SS score (with the modified SLEDAI-2K scoring for PU), no worsening (increase of \<0.30 points from OL Baseline) in PGA and no new BILAG A ODS or 2 new BILAG B ODS compared with OL Baseline. For participants switching from placebo to belimumab 10 mg/kg IV in the OL phase, Baseline was defined as the last assessment at the end of the double-blind phase (i.e. Week 52) pre-OL treatment. For participants that received belimumab 10 mg/kg IV during the double-blind phase and continued to receive belimumab 10 mg/kg IV during the OL phase, Baseline was defined as Day 1 of the double-blind phase. |
| Primary | Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] | Week 52 to Week 84 | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. Number of participants who had common nSAEs (\>=5%) and any SAEs are presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Primary | Number of Participants With Severe AEs [OL Phase] | Week 52 to Week 84 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Primary | Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase] | Week 52 to Week 84 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AEs leading to treatment discontinuation have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Primary | Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] | Week 52 to Week 84 | Blood samples were collected for the assessment of hematology parameters. The parameters assessed were activated partial thromboplastin time (APTT), hemoglobin, leukocytes, neutrophils, platelets and prothrombin time. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to Division of Microbiology and Infectious Diseases (DMID \[Modified from DMID Adult Toxicity Tables, 2001\]) AE Severity Grading. Number of participants with worst toxicity Grade 3 or 4 for hematology parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Primary | Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] | Week 52 to Week 84 | Blood samples were collected for the assessment of liver function and other chemistry parameters. The parameters assessed were alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), bilirubin, albumin, creatinine, hyperglycemia, hypoglycemia and urate. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity Grade of 3 or 4 for liver function and other chemistry parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Primary | Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] | Week 52 to Week 84 | Urinalysis parameters assessed were urine protein and protein/creatinine. Urine samples were collected for the measurement of urinalysis parameters by dipstick method. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life-threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 for urinalysis parameters have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Primary | Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase] | Week 52 to Week 84 | Serum samples were obtained for the measurement of immunoglobulin G. Grading was assigned as mild (Grade 1), moderate (grade 2), severe (Grade 3) and potentially life threatening (Grade 4) according to DMID AE Severity Grading. Number of participants with worst toxicity grade of 3 or 4 of immunoglobulin G have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84). |
| Secondary | Percentage of Participants Achieving SRI-SS Response Rate at Week 52 [DB Phase] | Week 52 | SRI is defined as \>=4 point reduction, from Baseline in SS score, 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. Drop-outs and Treatment failures were set to non-responders. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SS score (\<=9 vs. \>=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and region (US/Canada vs. Rest of World). |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase] | Week 52 | mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase | Week 24 of OL phase (Week 76) | mITT OL population comprised of Intent-to-Treat (ITT) OL population (all randomized participants who received at least one dose of OL treatment) excluding participants who had any assessment at 3 sites (202196, 202513 or 107286). Only those participants with data available at the specified data points were analyzed. | Percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] | Week 52 to Week 84 | Intent-to-Treat (ITT) OL Population comprised of all randomized participants who received atleast one dose of open label treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Severe AEs [OL Phase] | Week 52 to Week 84 | ITT OL Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase] | Week 52 to Week 84 | ITT OL Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Worst Toxicity Grade 3 or 4 for Hematology Parameters [OL Phase] | Week 52 to Week 84 | ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Worst Toxicity Grade of 3 or 4 for Clinical Chemistry Parameters [OL Phase] | Week 52 to Week 84 | ITT OL Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Worst Toxicity Grade of 3 or 4 for Urinalysis Parameters [OL Phase] | Week 52 to Week 84 | ITT OL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Worst Toxicity Grade of 3 or 4 of Immunoglobulins [OL Phase] | Week 52 to Week 84 | ITT OL Population. Only those participants with data available at the specified data points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving SRI-SS Response Rate at Week 52 [DB Phase] | Week 52 | mITT Population. One participant in the mITT population Belimumab 10 mg/kg arm did not have a screening or Baseline PGA assessment; therefore, this participant did not contribute to the SRI/component analysis. | Percentage of participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group158
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase] | Placebo (DB Phase) | 41.6 | Percentage of participants | ||
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index (SRI) Response Rate With the Modified Systemic Lupus Erythematosus Disease Activity Index- 2K (SLEDAI-2K) Scoring for Proteinuria at Week 52 [DB Phase] | Belimumab 10 mg/kg (DB Phase) | 48.7 | Percentage of participants | ||
| Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase | Placebo to Belimumab 10 mg/kg (OL Phase) | 18.8 | Percentage of participants | ||
| Percentage of Participants Achieving a SRI Response Rate With the Modified SLEDAI-2K Scoring for Proteinuria at Week 24 of OL Phase | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | 73.6 | Percentage of participants | ||
| Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] | Placebo to Belimumab 10 mg/kg (OL Phase) | nSAEs | 23 | Participants | |
| Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | nSAEs | 49 | Participants | |
| Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] | Placebo to Belimumab 10 mg/kg (OL Phase) | SAEs | 6 | Participants | |
| Number of Participants With Non-serious Adverse Events (nSAEs) and Serious Adverse Event (SAEs) [OL Phase] | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | SAEs | 13 | Participants | |
| Number of Participants With Severe AEs [OL Phase] | Placebo to Belimumab 10 mg/kg (OL Phase) | 10 | Participants | ||
| Number of Participants With Severe AEs [OL Phase] | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | 9 | Participants |
1 to 10 of 158Source ClinicalTrials.gov
See all 158 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blinded (Up to Week 52) | STARTED | Placebo to Belimumab 10 mg/kg | 165 | |
| Double-blinded (Up to Week 52) | STARTED | Belimumab 10 mg/kg to Belimumab 10 mg/kg | 331 | |
| Double-blinded (Up to Week 52) | COMPLETED | Placebo to Belimumab 10 mg/kg | 121 | |
| Double-blinded (Up to Week 52) | COMPLETED | Belimumab 10 mg/kg to Belimumab 10 mg/kg | 252 | |
| Double-blinded (Up to Week 52) | NOT COMPLETED | Placebo to Belimumab 10 mg/kg | 44 | |
| Double-blinded (Up to Week 52) | NOT COMPLETED | Belimumab 10 mg/kg to Belimumab 10 mg/kg | 79 | |
| Open-label (Week 52 to Week 76) | STARTED | Placebo to Belimumab 10 mg/kg | 117 | |
| Open-label (Week 52 to Week 76) | STARTED | Belimumab 10 mg/kg to Belimumab 10 mg/kg | 242 | |
| Open-label (Week 52 to Week 76) | COMPLETED | Placebo to Belimumab 10 mg/kg | 107 | |
| Open-label (Week 52 to Week 76) | COMPLETED | Belimumab 10 mg/kg to Belimumab 10 mg/kg | 220 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events480
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 | Upper respiratory tract infection | Infections and infestations | Placebo (DB Phase) | 14 | 165 | 20 |
| other | Upper respiratory tract infection | Infections and infestations | Belimumab 10 mg/kg (DB Phase) | 48 | 331 | 58 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo to Belimumab 10 mg/kg (OL Phase) | 4 | 117 | 6 |
| other | Upper respiratory tract infection | Infections and infestations | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | 20 | 242 | 21 |
| other | Urinary tract infection | Infections and infestations | Placebo (DB Phase) | 19 | 165 | 24 |
| other | Urinary tract infection | Infections and infestations | Belimumab 10 mg/kg (DB Phase) | 43 | 331 | 57 |
| other | Urinary tract infection | Infections and infestations | Placebo to Belimumab 10 mg/kg (OL Phase) | 7 | 117 | 7 |
| other | Urinary tract infection | Infections and infestations | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | 13 | 242 | 15 |
| other | Headache | Nervous system disorders | Placebo (DB Phase) | 18 | 165 | 25 |
| other | Headache | Nervous system disorders | Belimumab 10 mg/kg (DB Phase) | 39 | 331 | 47 |
1 to 10 of 480Source ClinicalTrials.gov
See all 480 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo (DB Phase) | 0 | 165 |
| Total, all-cause mortality | Belimumab 10 mg/kg (DB Phase) | 2 | 331 |
| Total, all-cause mortality | Placebo to Belimumab 10 mg/kg (OL Phase) | 0 | 117 |
| Total, all-cause mortality | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | 0 | 242 |
| Total, other adverse events | Placebo (DB Phase) | 77 | 165 |
| Total, other adverse events | Belimumab 10 mg/kg (DB Phase) | 196 | 331 |
| Total, other adverse events | Placebo to Belimumab 10 mg/kg (OL Phase) | 23 | 117 |
| Total, other adverse events | Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) | 49 | 242 |
| Total, serious adverse events | Placebo (DB Phase) | 31 | 165 |
| Total, serious adverse events | Belimumab 10 mg/kg (DB Phase) | 36 | 331 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers6
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) vs Placebo to Belimumab 10 mg/kg (OL Phase): Number of Participants With Severe AEs [OL Phase] | Trial comparisons |
| Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) vs Placebo to Belimumab 10 mg/kg (OL Phase): Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase] | Trial comparisons |
| Belimumab 10 mg/kg (DB Phase) vs Placebo (DB Phase): Number of Participants With Severe AEs [DB Phase] | Trial comparisons |
| Belimumab 10 mg/kg (DB Phase) vs Placebo (DB Phase): Number of Participants With AEs Leading to Treatment Discontinuation [DB Phase] | 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/NCT01632241
GET https://conductscience.org/api/trials/v1/NCT01632241/registered?page=2