Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
Public ClinicalTrials.gov record NCT01729455. 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 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults With Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated With or Without BENLYSTA™ (Belimumab)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Study identification
- NCT ID
- NCT01729455
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3,138 participants
Conditions and interventions
Conditions
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
- Feb 21, 2013 (Actual)
- Primary completion
- Feb 28, 2025 (Actual)
- Completion
- Feb 28, 2025 (Actual)
- Last update posted
- Mar 20, 2026
2013 – 2025
United States locations
- U.S. sites
- 102
- U.S. states
- 30
- U.S. cities
- 88
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | — |
| GSK Investigational Site | Glendale | Arizona | 85304 | — |
| GSK Investigational Site | Goodyear | Arizona | 85395 | — |
| GSK Investigational Site | Phoenix | Arizona | 85032 | — |
| GSK Investigational Site | Phoenix | Arizona | 85037 | — |
| GSK Investigational Site | Prescott | Arizona | 86305 | — |
| GSK Investigational Site | Sun City | Arizona | 85351 | — |
| GSK Investigational Site | Tucson | Arizona | 85704 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Bakersfield | California | 93301 | — |
| GSK Investigational Site | La Mesa | California | 92020 | — |
| GSK Investigational Site | Lakewood | California | 90712 | — |
| GSK Investigational Site | Loma Linda | California | 92354 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Los Angeles | California | 90048 | — |
| GSK Investigational Site | Los Angeles | California | 90095 | — |
| GSK Investigational Site | Murrieta | California | 92563 | — |
| GSK Investigational Site | Pomona | California | 91767 | — |
| GSK Investigational Site | Upland | California | 91786 | — |
| GSK Investigational Site | West Hills | California | 91307 | — |
| GSK Investigational Site | Danbury | Connecticut | 06810 | — |
| GSK Investigational Site | New Haven | Connecticut | 06520 | — |
| GSK Investigational Site | Orangeburg | Connecticut | 06518 | — |
| GSK Investigational Site | Brandon | Florida | 33511 | — |
| GSK Investigational Site | Clearwater | Florida | 33759 | — |
| GSK Investigational Site | Fort Lauderdale | Florida | 33309 | — |
| GSK Investigational Site | Jupiter | Florida | 33458 | — |
| GSK Investigational Site | Largo | Florida | 33770 | — |
| GSK Investigational Site | Miami | Florida | 33126 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Palm Harbor | Florida | 34684 | — |
| GSK Investigational Site | Pembroke Pines | Florida | 33026 | — |
| GSK Investigational Site | Pensacola | Florida | 32514 | — |
| GSK Investigational Site | Plantation | Florida | 33324 | — |
| GSK Investigational Site | Atlanta | Georgia | 30303 | — |
| GSK Investigational Site | Gainesville | Georgia | 30501 | — |
| GSK Investigational Site | Meridian | Idaho | 83642 | — |
| GSK Investigational Site | Chicago | Illinois | 60611 | — |
| GSK Investigational Site | Chicago | Illinois | 60612 | — |
| GSK Investigational Site | Morton Grove | Illinois | 60053 | — |
| GSK Investigational Site | South Bend | Indiana | 46601 | — |
| GSK Investigational Site | Baton Rouge | Louisiana | 70809 | — |
| GSK Investigational Site | Shreveport | Louisiana | 71103 | — |
| GSK Investigational Site | Baltimore | Maryland | 21286 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01107 | — |
| GSK Investigational Site | Ann Arbor | Michigan | 48109-5542 | — |
| GSK Investigational Site | Ann Arbor | Michigan | 48917 | — |
| GSK Investigational Site | Detroit | Michigan | 48202 | — |
| GSK Investigational Site | Eagan | Minnesota | 55121 | — |
| GSK Investigational Site | Edina | Minnesota | 55435 | — |
| GSK Investigational Site | Jackson | Mississippi | 39216 | — |
| GSK Investigational Site | Tupelo | Mississippi | 38801 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | St Louis | Missouri | 63117 | — |
| GSK Investigational Site | St Louis | Missouri | 63132 | — |
| GSK Investigational Site | Omaha | Nebraska | 68198-7680 | — |
| GSK Investigational Site | Henderson | Nevada | 89052 | — |
| GSK Investigational Site | Summit | New Jersey | 07901 | — |
| GSK Investigational Site | Teaneck | New Jersey | 07666 | — |
| GSK Investigational Site | Voorhees Township | New Jersey | 08103 | — |
| GSK Investigational Site | Manhasset | New York | 11030 | — |
| GSK Investigational Site | Mineola | New York | 11501 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | New York | New York | 10021 | — |
| GSK Investigational Site | Roslyn | New York | 11576 | — |
| GSK Investigational Site | Smithtown | New York | 11787 | — |
| GSK Investigational Site | The Bronx | New York | 10461 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Greensboro | North Carolina | 27405 | — |
| GSK Investigational Site | New Bern | North Carolina | 28562 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27617 | — |
| GSK Investigational Site | Rocky Mount | North Carolina | 27804 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27157 | — |
| GSK Investigational Site | Columbus | Ohio | 43203 | — |
| GSK Investigational Site | Toledo | Ohio | 43614 | — |
| GSK Investigational Site | Edmond | Oklahoma | 73013 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73103 | — |
| GSK Investigational Site | Oklahoma City | Oklahoma | 73104 | — |
| GSK Investigational Site | Oklahoma City6 | Oklahoma | 73103 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74104 | — |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425 | — |
| GSK Investigational Site | Hixson | Tennessee | 37343-7908 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
| GSK Investigational Site | Allen | Texas | 75013 | — |
| GSK Investigational Site | Arlington | Texas | 22205-3606 | — |
| GSK Investigational Site | Houston | Texas | 77004 | — |
| GSK Investigational Site | Houston | Texas | 77034 | — |
| GSK Investigational Site | Nassau Bay | Texas | 77058 | — |
| GSK Investigational Site | Round Rock | Texas | 78665 | — |
| GSK Investigational Site | San Marcos | Texas | 78666 | — |
| GSK Investigational Site | The Woodlands | Texas | 77382 | — |
| GSK Investigational Site | Danville | Virginia | 24541 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Roanoke | Virginia | 24016 | — |
| GSK Investigational Site | Seattle | Washington | 98133 | — |
| GSK Investigational Site | Glendale | Wisconsin | 91204 | — |
| GSK Investigational Site | Manitowoc | Wisconsin | 54221-1450 | — |
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 77 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01729455, 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 Mar 20, 2026 · Synced Oct 28, 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 NCT01729455 live on ClinicalTrials.gov.