BENLYSTA® Special Drug Use Investigation
不适用
已完成
NCT03370263
| 适应症 | Systemic Lupus Erythematosus |
|---|
| 分期 | 不适用 |
|---|
| 申办方 | GlaxoSmithKline |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 1,514 人 |
|---|
| 干预（药物） | Benlysta |
|---|
| 开始日期 | 2018年1月15日 |
|---|
| 完成日期 | 2025年7月31日 |
|---|
| 结果公布日 | 2026年5月18日 |
|---|
摘要
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Number of Participants With Adverse Drug Reactions (ADRs)
From the start of the study intervention (Day 1) up to maximum of 3 years · Participants
| Benlysta IV | 107 Participants |
|---|
| Benlysta SC | 110 Participants |
|---|
| Benlysta Switched From IV to SC or SC to IV | 47 Participants |
|---|
| Benlysta IV or SC (Initial Route of Administration Unknown) | 0 Participants |
|---|
Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
From the start of the study intervention (Day 1) up to maximum of 3 years · Participants
| Benlysta IV | 3 Participants |
|---|
| Benlysta SC | 0 Participants |
|---|
| Benlysta Switched From IV to SC or SC to IV | 0 Participants |
|---|
| Benlysta IV or SC (Initial Route of Administration Unknown) | 0 Participants |
|---|
| Benlysta IV | 27 Participants |
|---|
| Benlysta SC | 24 Participants |
|---|
Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
Baseline (Day 0) and Week 24 · Scores on a Scale
| Benlysta IV | -2.5 ± 4.8 Scores on a Scale |
|---|
| Benlysta SC | -2.8 ± 4.3 Scores on a Scale |
|---|
| Benlysta Switched From IV to SC or SC to IV | -2.8 ± 4.3 Scores on a Scale |
|---|
| Benlysta IV or SC (Initial Route of Administration Unknown) | -4.0 ± NA Scores on a Scale |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
同一适应症的其他试验
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。