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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04325217

Enrollment

586

Registered

2020-03-27

Start date

2020-05-27

Completion date

2026-07-13

Last updated

2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases, Interstitial

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 data generated in patients with SSc-ILD.

Interventions

DRUGNintedanib

Capsules

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse drug reactions (ADRs)	up to 3 years and 9 months	Focus on gastrointestinal symptoms including diarrhea and nausea

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026