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NCT01729455 · ClinicalTrials.gov registry record
Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
A clinical trial, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 3,138
- Enrollment target
NCT01729455 is a clinical trial that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,138 participants.
The verdict
NCT01729455 has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 3,138 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Benlysta
- OTHER Standard of Care (SoC) Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,138 participants |
| Start Date | 2013-02-21 |
| Est. Completion | 2025-02-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01729455
The ClinicalTrials.gov registry entry for NCT01729455 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 3,138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Benlysta is the first listed.
NCT01729455 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01729455 about?
NCT01729455 is a clinical study titled "Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry". 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 coho...
What is the current status of trial NCT01729455?
This trial is currently completed. The enrollment target is 3,138 participants. The study started on 2013-02-21. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT01729455?
The interventions under investigation include: Benlysta (BIOLOGICAL), Standard of Care (SoC) Therapy (OTHER).
Who is sponsoring clinical trial NCT01729455?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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