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

Withdrawn

• Conditions: Ulcerative Colitis

• Registration Number: NCT04156672
• Lead Sponsor: Pfizer

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 .

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Study Start: 2020-10-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of participants with steroid use	at baseline
Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations	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
Total time without steroids since initiation of current advanced therapy	since initiation current advanced 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 comorbidities	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
Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g	at baseline
Frequency and incidence of hospitalizations and emergency visits	since initiation current adavnced therapy till baseline
Duration of symptomatic remission	since initiation symptomatic remission till baseline