Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal

Pfizer

Overview

This study aims to characterize the Portuguese population of patients with moderate-to-severe UC receiving advanced therapies, by describing clinical and sociodemographic characteristics, and remission outcomes . The clinical, biochemical, endoscopic, and histological outcomes will also be described, as well as frequency of selected EIM, comorbidities and the uptake of preventive care measures and hospitalizations .

Study Type

OBSERVATIONAL

Conditions

Ulcerative Colitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged at least 18 years old * Diagnosed with Ulcerative Colitis, confirmed by a gastroenterologist * Treated with anti-TNF or anti-integrin or JAK inhibitors drugs for at least 16 weeks * Followed at one of the participating centers when initiating and during the current treatment * Signed informed consent Exclusion Criteria: * Treated with anti-TNF or anti-integrin or JAK inhibitors drugs at induction phase * Enrolled in randomized clinical trials or other experimental studies in the last 12 months prior to initiation of advanced therapy

Outcomes

Primary Outcomes

Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission

\- percentage of participants with both a Mayo stool frequency subscore of 0 or 1 and Mayo rectal bleeding subscore of 0 , and a Faecal Calprotectin concentrations \< to the cut-off concentration of 150-200 μg/g

Time frame: at baseline

Demographics and clinical characteristics of Ulcerative Colitis participants

* percentage of gender distribution, age distribution, smoking status distribution, height and weight distribution, BMI distribution * percentage of Ulcerative Colitis extend and severity (Montreal criteria) distribution, percentage of prior acute severe Ulcerative Colitis, percentage of clinical relapses

Time frame: till baseline

Secondary Outcomes

Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration

Time frame: at baseline

Proportion of Ulcerative Colitis participants with symptomatic remission

Time frame: at baseline

Duration of symptomatic remission

Time frame: since initiation symptomatic remission till baseline

Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g

Time frame: at baseline

Proportion of participants with steroid use

Time frame: at baseline

Total time without steroids since initiation of current advanced therapy

Data from ClinicalTrials.gov

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