Post-marketing Surveillance on Long Term Use of Ofev Capsules in Systemic Scleroderma Associated Interstitial Lung Disease (SSc-ILD) in Japan
1 other identifier
observational
586
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
March 17, 2026
March 1, 2026
6.1 years
March 26, 2020
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse drug reactions (ADRs)
Focus on gastrointestinal symptoms including diarrhea and nausea
up to 3 years and 9 months
Study Arms (1)
Patients newly initiating Ofev®/Nintedanib Capsules
Interventions
Eligibility Criteria
As this is a non-interventional study, no specific treatment is mandated or withheld from the patients. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.
You may qualify if:
- 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, 1416017, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 27, 2020
Study Start
May 27, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
- Access Criteria
- For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.