Clinical trial

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

Name

1199-0387

Description

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.

Trial arms

Trial start

2020-04-15

Estimated PCD

2026-06-30

Trial end

2026-09-30

Status

Active (not recruiting)

Treatment

Nintedanib

Capsules

Arms:

Patients newly initiating Ofev®/Nintedanib Capsules

Other names:

Ofev®

Size

585

Primary endpoint

Incidence of adverse drug reactions (ADRs)

up to 3 years and 9 months

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 585, 'type': 'ACTUAL'}}

Updated at

2024-04-23

1 organization

1 product

2 indications

Product

Indication

Indication

Organization