NCT04325217Completed
Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 586 (actual)
- First submitted
- 26 Mar 2020
- Start date
- 27 May 2020
- Primary completion date
- 13 Jul 2026
- Lead sponsor
- Boehringer Ingelheim
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT04325217
What you commit to
- Study type: Observational
- Participants enrolled: 586
- From 27 May 2020 to the primary completion date, 13 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- None.
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.