Clinical trial NCT04156672: Real World Study Of The Clinical Profile And Treatment Outcomes Of Advanced Therapies For Ulcerative Colitis In Portugal
Official title: REal-world Study of the Clinical Profile and Treatment Outcomes of Advanced Therapies for Ulcerative Colitis in Portugal-READ UC
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ulcerative Colitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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 .


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission
timeFrame: at baseline
measure: Demographics and clinical characteristics of Ulcerative Colitis participants
timeFrame: till baseline
Secondary outcomes:
measure: Proportion of participants achieving remission at study appointment, defined as both symptomatic and faecal biomarker remission, by previous treatment line and by treatment duration
timeFrame: at baseline
measure: Proportion of Ulcerative Colitis participants with symptomatic remission
timeFrame: at baseline
measure: Duration of symptomatic remission
timeFrame: since initiation symptomatic remission till baseline
measure: Proportion of participants with faecal biomarker <150-200 μg/g and >150-200 μg/g
timeFrame: at baseline
measure: Proportion of participants with steroid use
timeFrame: at baseline
measure: Total time without steroids since initiation of current advanced therapy
timeFrame: since initiation current advanced therapy till baseline
measure: Proportion of participants in steroid-free remission
timeFrame: at baseline
measure: Time spent in hospital, including all Inflammatory Bowel Disease-related admissions requiring an overnight stay
timeFrame: since initiation current advanced therapy till baseline
measure: Frequency and incidence of hospitalizations and emergency visits
timeFrame: since initiation current adavnced therapy till baseline
measure: Frequency of registered preventive care measures
timeFrame: in the 12 months prior initiation current advanced therapy till baseline
measure: Proportion of Ulcerative Colitis participants with history or current evidence of Extra Intestinal Manifestations
timeFrame: till baseline
measure: Proportion of Ulcerative Colitis participants with history or current evidence of comorbidities
timeFrame: till baseline
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: