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

Overview

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 .

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: September 30, 2020

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration
    • Time Frame: at baseline
  • Proportion of Ulcerative Colitis participants with symptomatic remission
    • Time Frame: at baseline
  • Duration of symptomatic remission
    • Time Frame: since initiation symptomatic remission till baseline
  • Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g
    • Time Frame: at baseline
  • Proportion of participants with steroid use
    • Time Frame: at baseline
  • Total time without steroids since initiation of current advanced therapy
    • Time Frame: since initiation current advanced therapy till baseline
  • Proportion of participants in steroid-free remission
    • Time Frame: at baseline
  • Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay
    • Time Frame: since initiation current advanced therapy till baseline
  • Frequency and incidence of hospitalizations and emergency visits
    • Time Frame: since initiation current adavnced therapy till baseline
  • Frequency of registered preventive care measures
    • Time Frame: 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
    • Time Frame: till baseline
  • Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities
    • Time Frame: till baseline

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer
  • Overall Contact(s)
    • Pfizer CT.gov Call Center, 1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

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