Systemic sclerosis
Conditions
Interventions
None listed
Sponsors
NPO Japan PH Registry
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who give written consent (provide opportunity to refuse, to the patients who had been registered in EUSTAR database and with difficulty in written consent) 2)20 years or older at the time of consent 3)Patients who are diagnosed as having SSc and meet the 2013 American college of Rheumatology (ACR)/ European League against Rheumatism (EULAR) classification criteria for SSc; 4)Patients with or without ILD. In case of SSc-ILD patients, ILD has been confirmed by high-resolution computed tomography (HRCT) at the time of baseline or follow-up. 5)Accepted whether registered in EUSTAR database or not. In patients who have been registered in EUSTAR database, the data recorded in EUSTAR database may be collected retrospectively.
Exclusion criteria
Exclusion criteria: 1)Participation in clinical trials for NDA concurrently or scheduled during this registry, excluding studies other than clinical trials for NDA (e.g., specified clinical trial defined in Clinical Trials Act) 2)Unsuitable for enrolment into this study by the investigator's or sub-investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of SSc organ involvement defined by previous studies A)ILD B)PH C)Renal crisis D)Upper gastrointestinal involvement E)Lower gastrointestinal involvement F)Myocardial involvement G)Digital ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| A)Time to onset of organ failure event B)Time to death C)Rate of patients who meet the criteria of low disease activity advocated by World Scleroderma Foundation: WSF (at 1, 2, 3 years) D)Rate of patients with progressive pulmonary fibrosis (at 1, 3 years) E)Predictive factor for progression of pulmonary fibrosis in patients with SSc-ILD | — |
Countries
Japan
Contacts
Public ContactAki Mandokoro
SRD Co., Ltd. Clinical Research Department
Outcome results
None listed