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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04156672
Other study ID # A3921353
Secondary ID READ UC
Status Withdrawn
Phase
First received
Last updated
Start date October 6, 2020
Est. completion date April 30, 2021

Study information

Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 .


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at baseline
Primary 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
till baseline
Secondary 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
Secondary Proportion of Ulcerative Colitis participants with symptomatic remission at baseline
Secondary Duration of symptomatic remission since initiation symptomatic remission till baseline
Secondary Proportion of participants with faecal biomarker <150-200 µg/g and >150-200 µg/g at baseline
Secondary Proportion of participants with steroid use at baseline
Secondary Total time without steroids since initiation of current advanced therapy since initiation current advanced therapy till baseline
Secondary Proportion of participants in steroid-free remission at baseline
Secondary Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay since initiation current advanced therapy till baseline
Secondary Frequency and incidence of hospitalizations and emergency visits since initiation current adavnced therapy till baseline
Secondary Frequency of registered preventive care measures in the 12 months prior initiation current advanced therapy till baseline
Secondary Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations till baseline
Secondary Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities till baseline
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