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

NCT04156672 | Withdrawn

• 2 other identifiers: A3921353READ UC
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: November 7, 2019
• Study Start: October 6, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share