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Non-interventional cohort study in patients with newly initiated Spesolimab to evaluate the incidence of adverse drug reactions and to understand generalized pustular psoriasis (GPP) disease activities in the real world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with generalized pustular psoriasis (GPP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spesolimab | Drug | Spesolimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADRs) | Incidence of adverse drug reactions (ADRs). An ADR is defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors. | Up to 36 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with generalized pustular psoriasis (GPP).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | 1416017 | Japan |
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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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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000712973 | spesolimab |
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