All-Case Surveillance of Ofev in Patients With IPF in Japan
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
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.