Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan

Boehringer Ingelheim

Status: Active, not recruiting

Conditions: Lung Diseases, Interstitial

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT04325217

1199-0387

Details and patient eligibility

About

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 data generated in patients with SSc-ILD.

Enrollment: 586 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• None.

Trial design

586 participants in 1 patient group

Patients newly initiating Ofev®/Nintedanib Capsules

Treatment:

Drug: Nintedanib