Belimumab Assessment of Safety in SLE
Public ClinicalTrials.gov record NCT01705977. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.
Study identification
- NCT ID
- NCT01705977
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 4,019 participants
Conditions and interventions
Conditions
Interventions
- Placebo plus standard therapy Biological
- Belimumab 10 mg/kg plus standard therapy Biological
- Standard therapy Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2012 (Actual)
- Primary completion
- Jul 30, 2018 (Actual)
- Completion
- Aug 10, 2022 (Actual)
- Last update posted
- Jul 15, 2024
2012 – 2022
United States locations
- U.S. sites
- 49
- U.S. states
- 19
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | — |
| GSK Investigational Site | Birmingham | Alabama | 35216 | — |
| GSK Investigational Site | Huntsville | Alabama | 35801 | — |
| GSK Investigational Site | Glendale | Arizona | 85304 | — |
| GSK Investigational Site | Mesa | Arizona | 85202 | — |
| GSK Investigational Site | Phoenix | Arizona | 85032 | — |
| GSK Investigational Site | Phoenix | Arizona | 85037 | — |
| GSK Investigational Site | Covina | California | 91722 | — |
| GSK Investigational Site | Huntington Beach | California | 92646 | — |
| GSK Investigational Site | La Mesa | California | 92020 | — |
| GSK Investigational Site | Long Beach | California | 90808 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Murrieta | California | 92563 | — |
| GSK Investigational Site | Sacramento | California | 95816 | — |
| GSK Investigational Site | San Leandro | California | 94578 | — |
| GSK Investigational Site | Clearwater | Florida | 33756 | — |
| GSK Investigational Site | Hialeah | Florida | 33012 | — |
| GSK Investigational Site | Tampa | Florida | 33614 | — |
| GSK Investigational Site | Cedar Rapids | Iowa | 52403 | — |
| GSK Investigational Site | Saint Clair Shores | Michigan | 48081 | — |
| GSK Investigational Site | West Bloomfield | Michigan | 48322 | — |
| GSK Investigational Site | Jackson | Mississippi | 39216 | — |
| GSK Investigational Site | Kalispell | Montana | 59901 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89128 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45229 | — |
| GSK Investigational Site | Columbus | Ohio | 43203 | — |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | — |
| GSK Investigational Site | Wyomissing | Pennsylvania | 19610 | — |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | — |
| GSK Investigational Site | Rock Hill | South Carolina | 29732 | — |
| GSK Investigational Site | Summerville | South Carolina | 29486 | — |
| GSK Investigational Site | Hixson | Tennessee | 37343-7908 | — |
| GSK Investigational Site | Memphis | Tennessee | 38119 | — |
| GSK Investigational Site | Cypress | Texas | 77429 | — |
| GSK Investigational Site | Dallas | Texas | 75246 | — |
| GSK Investigational Site | Houston | Texas | 77004 | — |
| GSK Investigational Site | Houston | Texas | 77034 | — |
| GSK Investigational Site | Houston | Texas | 77084 | — |
| GSK Investigational Site | McKinney | Texas | 75071 | — |
| GSK Investigational Site | Webster | Texas | 77450 | — |
| GSK Investigational Site | Arlington | Virginia | 22205-3606 | — |
| GSK Investigational Site | Spokane | Washington | 99204 | — |
| GSK Investigational Site | Beckley | West Virginia | 25801 | — |
| GSK Investigational Site | Clarksburg | West Virginia | 26301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 201 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01705977, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 15, 2024 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01705977 live on ClinicalTrials.gov.