PMS Registry
Company Name
Janssen, Jahnson & Johnson
Protocol Number
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
Period of Study
From:05/05/2021 to:04/30/2025
Number of Patients
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