Status:
ACTIVE_NOT_RECRUITING
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lung Diseases, Interstitial
Eligibility:
All Genders
Brief Summary
The primary objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhoea and nausea) to Ofev Capsules seen in clinical trials with real world...
Eligibility Criteria
Inclusion
- Patients in Japan with SSc-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.
Exclusion
- None.
Key Trial Info
Start Date :
May 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2026
Estimated Enrollment :
586 Patients enrolled
Trial Details
Trial ID
NCT04325217
Start Date
May 27 2020
End Date
September 30 2026
Last Update
December 2 2025
Active Locations (1)
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1
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, Japan, 1416017