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OpenTrials
Completed

NCT Number: NCT04325217

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

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.

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Key information

Conditions

Lung Diseases, Interstitial Lung Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nintedanib

Drug

Capsules

Other names: Ofev®

Primary outcomes

  1. Incidence of adverse drug reactions (ADRs)

    Time frame: up to 3 years and 9 months

    Focus on gastrointestinal symptoms including diarrhea and nausea

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2020
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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