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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS106792 | Registry Identifier | EMA RWD catalogue |
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This post-approval registry study is planned to generate data to address remaining questions on long-term effectiveness and to better characterize longer term beneficial effects of Nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) in terms of survival, quality of life, pattern of disease progression as well as effectiveness and safety in the subgroup of patients with pulmonary hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | Individuals that initiate Ofev® including either:
|
| |
| Unexposed group | Individuals that do not initiate Ofev® during the study period and can include the following:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ofev® | Drug | Ofev® |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to absolute Forced Vital Capacity (FVC) decline (% predicted) ≥5%, lung transplantation (indicating end stage ILD), or death | up to 10 years | |
| Time to absolute FVC decline (% predicted) ≥10%, lung transplantation (indicating end-stage ILD), or deat | up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to absolute (% predicted) FVC decline ≥5% | up to 10 years | |
| Time to absolute (% predicted) FVC decline ≥10% | up to 10 years | |
| Time to relative (ml) FVC decline ≥5% |
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Inclusion Criteria:
Exclusion Criteria:
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The study cohort will constitute patients with Systemic Sclerosis (SSc) and Interstitial Lung Disease (ILD) (based on radiological evidence) enrolled in the European Scleroderma Trials and Research (EUSTAR) registry.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EUSTAR Registry | Basel | 4051 | Switzerland |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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| up to 10 years |
| Time to relative (ml) FVC decline ≥10% | up to 10 years |
| Time to lung transplantation (indicating end-stage ILD) | up to 10 years |
| Time to death | up to 10 years |
| Change from baseline in FVC (% predicted) | at baseline, up to 10 years |
| Change from baseline in FVC (ml) | at baseline, up to 10 years |
| Lung specific Quality of Life (QoL) measured as change from baseline of total, impact, and symptom scores using the Living with Pulmonary Fibrosis (L-PF) questionnaire, measured as change of baseline at years 1, 2, 3,….10 | The L-PF patient reported outcome measure (PROM) is a questionnaire designed for patients with fibrosing ILDs and developed with those patients to investigate their level of symptoms and QoL. The L-PF consists of two modules, symptoms and impacts, and five scales: symptoms total, dyspnea, cough, fatigue, impacts total, and Total L-PF score. Items in both modules have response options on a five-option numeric rating score with an anchor of 0 "Not at all" to 4 "Extremely". Overall scores range from 0 to 100, with higher numbers indicating a greater impairment. | at baseline, up to 10 years |
| Time to worsening of Pulmonary Hypertension (PH) in the sub-population of patients with PH at baseline | Worsening of PH is defined as a composite outcome of the following:
| up to 10 years |
| Incidence rate of major bleeding (defined as those requiring intervention or hospitalization) in exposed vs unexposed treatment groups | up to 10 years |
| Final outcome for the major bleeding events (i.e., recovered or fatal) overall | up to 10 years |
| Proportion of patients with major bleeding that had a pre-existing risk for bleeding | up to 10 years |
| Incidence rate of gastrointestinal perforations in exposed vs unexposed treatment groups | up to 10 years |
| Final outcome (i.e., recovered or fatal) for gastrointestinal perforation events overall | up to 10 years |
| Proportion of patients with gastrointestinal perforations that had a pre-existing risk for gastrointestinal perforations | up to 10 years |
| Incidence rate of thromboembolism (arterial or venous) in exposed vs unexposed treatment groups | up to 10 years |
| Final outcome (i.e., recovered or fatal) for thromboembolic events overall | up to 10 years |
| Proportion of patients with thromboembolism that had a pre-existing risk for thromboembolism | up to 10 years |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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