A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)
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| ClinicalTrials.gov Identifier: NCT01484496 |
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Recruitment Status :
Completed
First Posted : December 2, 2011
Results First Posted : July 25, 2017
Last Update Posted : June 6, 2018
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Sponsor:
Human Genome Sciences Inc., a GSK Company
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Systemic Lupus Erythematosus |
| Interventions |
Biological: Placebo Biological: Belimumab 200 mg SC Drug: Standard therapy |
| Enrollment | 839 |
Participant Flow
| Recruitment Details | Participants (Par.) with active systemic lupus erythematosus (SLE) and who were on appropriate stable standard SLE therapy for a period of at least 30 days prior to Day 0 before entering the study were eligible for participation in the study. |
| Pre-assignment Details | A total of 1427 par. were screened, out of these 588 par. were screen failures and 839 par. were randomized, of which 836 par. received at least one dose of study treatment. Par. who successfully completed the initial 52-week Double-blind Phase had a choice to enter into a 6-month Open-label Extension Phase of this study. |
| Arm/Group Title | Placebo SC | Belimumab 200 mg SC | Open-Label - Placebo SC to Belimumab 200 mg SC | Open-Label - Belimumab 200 SC to Belimumab 200 mg SC |
|---|---|---|---|---|
 Arm/Group Description |
Par. received placebo administered subcutaneously (SC) once weekly through 51 weeks of thetreatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. | Par. received belimumab 200 milligrams (mg) administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. | Par. received placebo administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly. | Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. Par. who completed the Double-Blind phase with active SLE were assessed for eligibility to participate in a 6-month extension phase during which they received open label belimumab 200 mg SC weekly |
| Period Title: Period 1 | ||||
| Started | 280 | 556 | 0 | 0 |
| Completed | 214 | 463 | 0 | 0 |
| Not Completed | 66 | 93 | 0 | 0 |
| Reason Not Completed | ||||
| Protocol Violation | 3 | 4 | 0 | 0 |
| Physician Decision | 5 | 1 | 0 | 0 |
| Lack of Efficacy | 10 | 15 | 0 | 0 |
| Adverse Event | 25 | 40 | 0 | 0 |
| Withdrawal by Subject | 15 | 12 | 0 | 0 |
| Lost to Follow-up | 2 | 6 | 0 | 0 |
| Positive Pregnancy | 1 | 6 | 0 | 0 |
| Treatment Failure | 3 | 6 | 0 | 0 |
| Lack of Compliance | 2 | 1 | 0 | 0 |
| Unable to Visit Site | 0 | 2 | 0 | 0 |
| Period Title: Period 2 | ||||
| Started | 0 | 0 | 206 | 456 |
| Completed | 0 | 0 | 191 | 434 |
| Not Completed | 0 | 0 | 15 | 22 |
| Reason Not Completed | ||||
| Lack of Efficacy | 0 | 0 | 1 | 3 |
| Adverse Event | 0 | 0 | 5 | 13 |
| Other | 0 | 0 | 9 | 6 |
Baseline Characteristics
| Arm/Group Title | Placebo SC | Belimumab 200 mg SC | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Par. received placebo administered SC, once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. | Par. received belimumab 200 mg administered SC once weekly through 51 weeks of the treatment period. Par. continued with the stable standard therapy they were receiving during the Screening Period. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 280 | 556 | 836 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 280 participants | 556 participants | 836 participants | |
| 39.6 (12.61) | 38.1 (12.10) | 38.6 (12.29) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 280 participants | 556 participants | 836 participants | |
| Female |
268 95.7%
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521 93.7%
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789 94.4%
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| Male |
12 4.3%
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35 6.3%
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47 5.6%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 280 participants | 556 participants | 836 participants |
| White/Caucasian/European Heritage | 160 | 326 | 486 | |
| Middle East/North African Heritage | 6 | 10 | 16 | |
| Central Asian Heritage | 0 | 2 | 2 | |
| East Asian Heritage | 15 | 29 | 44 | |
| Japanese Heritage | 16 | 13 | 29 | |
| South Asian Heritage | 0 | 2 | 2 | |
| Southeast Asian Heritage | 32 | 73 | 105 | |
| African American/African Heritage | 30 | 56 | 86 | |
| American Indian or Alaska Native | 21 | 43 | 64 | |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title: | GSK Response Center |
| Organization: | GlaxoSmithKline |
| Phone: | 866-435-7343 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline ( Human Genome Sciences Inc., a GSK Company ) |
| ClinicalTrials.gov Identifier: | NCT01484496 |
| Other Study ID Numbers: |
112341 2011-003814-18 HGS1006-C1115 |
| First Submitted: | November 28, 2011 |
| First Posted: | December 2, 2011 |
| Results First Submitted: | January 30, 2017 |
| Results First Posted: | July 25, 2017 |
| Last Update Posted: | June 6, 2018 |