Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal (READ-UC)

REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC

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 Overview

• Status: Withdrawn
• Conditions: Ulcerative Colitis

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients followed at Portuguese gastroenterology services, presenting moderate-to-severe Ulcerative Colitis and receiving advanced therapies (i.e., anti-TNF or anti-integrin or JAK inhibitors drugs) for at least 16 weeks.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
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 Ulcerative Colitis participants with symptomatic remission	at baseline
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
Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay	since initiation current advanced therapy till 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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start (Anticipated): October 6, 2020
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A3921353; READ UC (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.