| Company Name | Janssen, Jahnson & Johnson |
|---|---|
| Protocol Number | 67896062PUH4002 |
| Title of Study | Multicenter observational drug registry of Opsumit® (macitentan) in connective tissue disease associated pulmonary arterial hypertension (CTD-PAH) in real world Taiwan clinical setting |
| Primary Objective | 1. To describe demographic and clinical characteristics of CTD-PAH patients treated with Opsumit® at enrollment and during the observation period in Taiwan 2. To understand the clinical impact of the Opsumit® usage restrictions as set forth by Taiwan’s National Health Insurance Administration 3. To understand how underlying CTD disease treatment affects PAH management and vice versa |
| Number of Sites | 6 |
| Period of Study | From：05/05/2021 to：04/30/2025 |
| Number of Patients | 60人 |
| IRB Approval Date | NTUH: 2020/11/25 KSCGMH: 2021/01/19 TCVGH: 2021/01/21 LKCGMH: 2021/01/197 TPVGH: 2021/02/04 TSGH: 2022/05/30 |
| Publication Plan / Date | 2025 Q4 |
