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

NCT ID: NCT04156672

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-06

Study Completion Date

2021-04-30

Brief Summary

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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 .

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Other Identifiers

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READ UC

Identifier Type: OTHER

Identifier Source: secondary_id

A3921353

Identifier Type: -

Identifier Source: org_study_id

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