PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms

Boehringer Ingelheim52 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Generalized Pustular Psoriasis

Interventions

SpesolimabDRUG

Spesolimab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * GPP patients with acute symptoms who are administered Spesolimab Intravenous (I.V.) Infusion in Japan * Patients who have never been treated with Spesolimab I.V. Infusion before enrolment Exclusion Criteria: * None

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

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.

Time frame: Up to 36 weeks

Data from ClinicalTrials.gov

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