Idiopathic Pulmonary Fibrosis
Conditions
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.
Interventions
DRUGNintedanib
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Any Suspected Adverse Drug Reactions (ADRs) | Up to 104 weeks | Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104 | At baseline and at week 104 | Absolute change from baseline in Forced Vital Capacity (FVC) at Week 104 is presented. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured in Milliliter by spirometry. |
Countries
Japan
Participant flow
Recruitment details
This non-interventional study based on newly collected data aimed to evaluate safety and effectiveness of Ofev Capsules treatment in patients with Idiopathic Pulmonary Fibrosis (IPF) who newly initiated Ofev capsules under a real-world setting.
Pre-assignment details
Only subjects that met all inclusion and none of the exclusion criteria were included. Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st).
Participants by arm
| Arm | Count |
|---|---|
| IPF Patients Receiving Nintedanib Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023, following enrollment in August 31st). | 5,734 |
| Total | 5,734 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2,553 |
| Overall Study | Improved | 22 |
| Overall Study | Lack of Efficacy | 316 |
| Overall Study | Lost to Follow-up | 312 |
| Overall Study | missing info in CRF | 13 |
| Overall Study | No CRF collected | 138 |
| Overall Study | No data reliability | 1 |
| Overall Study | no patient visit | 18 |
| Overall Study | Not treated | 1 |
| Overall Study | Physician Decision | 367 |
| Overall Study | Withdrawal by Subject | 616 |
| Overall Study | without CRF | 4,225 |
Baseline characteristics
| Characteristic | IPF Patients Receiving Nintedanib | — |
|---|---|---|
| Age, Continuous | 71.7 Years STANDARD_DEVIATION 8.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 1256 Participants | — |
| Sex: Female, Male Male | 4478 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1,137 / 5,734 |
| other Total, other adverse events | 3,239 / 5,734 |
| serious Total, serious adverse events | 2,326 / 5,734 |
Outcome results
Primary
Number of Patients With Any Suspected Adverse Drug Reactions (ADRs)
Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented.
Time frame: Up to 104 weeks
Population: Safety set: This patient set included all patients who didn't have any predefined important protocol deviations (IPDs) leading to exclusion from this analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IPF Patients Receiving Nintedanib | Number of Patients With Any Suspected Adverse Drug Reactions (ADRs) | 3852 Participants |
Secondary
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104
Absolute change from baseline in Forced Vital Capacity (FVC) at Week 104 is presented. Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured in Milliliter by spirometry.
Time frame: At baseline and at week 104
Population: Effectiveness set: This patient set included all patients with Ofev Capsules in the safety set who were suffering from the approved indication. Further important protocol deviations (IPDs) leading to exclusion from this analysis set were predefined. Only patients with FVC and %FVC value at baseline and post treatment in effectiveness set were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IPF Patients Receiving Nintedanib | Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104 | -152.5 MilliLiter (mL) | Standard Deviation 323 |