All-Case Surveillance of Ofev in Patients With IPF in Japan
Study Details
Study Description
Brief Summary
This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment.
The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment.
As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed).
All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed.
Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Nintedanib Patients with IPF |
Drug: Nintedanib
|
Outcome Measures
Primary Outcome Measures
- The primary endpoint of this study is the frequency of patients with any suspected Adverse Drug Reactions (ADRs) [Week 104]
Secondary Outcome Measures
- The secondary endpoint of this study is absolute change from baseline in Forced Vital Capacity (FVC) [mL] at Week 104 [Week 104]
Eligibility Criteria
Criteria
Inclusion criteria:
Essentially, patients are diagnosed with IPF based upon the most recent the American Thoracic Society (ATS), the European Respiratory Society (ERS), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Association (ALAT) guideline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Multiple Locations | Japan |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 1199.202