Active — Not RecruitingNot Applicable

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

Japan586 participantsStarted 2020-05-27

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of adverse drug reactions (ADRs)

Timeframe: up to 3 years and 9 months

Trial details

NCT IDNCT04325217

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Lung Diseases, Interstitial trials