Ulcerative Colitis
Conditions
Brief summary
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 .
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission | at baseline | \- 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 |
| Demographics and clinical characteristics of Ulcerative Colitis participants | till baseline | * 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 |
Secondary
| Measure | Time frame |
|---|---|
| Duration of symptomatic remission | since initiation symptomatic remission till baseline |
| Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g | at baseline |
| Proportion of participants with steroid use | at baseline |
| Total time without steroids since initiation of current advanced therapy | since initiation current advanced therapy till baseline |
| Proportion of participants in steroid-free remission | at baseline |
| Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration | at baseline |
| Frequency and incidence of hospitalizations and emergency visits | since initiation current adavnced therapy till baseline |
| Frequency of registered preventive care measures | in the 12 months prior initiation current advanced therapy till baseline |
| Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations | till baseline |
| Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities | till baseline |
| Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay | since initiation current advanced therapy till baseline |
| Proportion of Ulcerative Colitis participants with symptomatic remission | at baseline |
Outcome results
None listed