Paricipant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe

NCT ID: NCT04597905

Last Updated: 2021-02-11

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

COMPLETED

Total Enrollment

686 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-21

Study Completion Date

2021-01-31

Brief Summary

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The purpose of this survey is to describe Crohn's disease (CD) participants' as well as ulcerative colitis (UC) participants' preferences towards the attributes of treatment with advanced therapies for IBD, including safety and efficacy profiles, frequency and route of administration (RoA) in a real-world setting.

Detailed Description

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This is a descriptive, observational, cross-sectional survey of participants with IBD. The survey will look into the preferences of participants towards the attributes of treatment with advanced therapies for IBD based on DCE (experimentally designed survey), including safety and efficacy profiles, frequency and RoA in a real-world setting, in European participants living with CD or UC.

The survey will involve data collection in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international participant community.

The survey will enroll approximately 600 participants. Participants will be enrolled in two observational cohorts:

* CD Participants
* UC Participants

This multi-center trial will be conducted in France, the United Kingdom, Italy, Spain, Belgium, Switzerland, the Netherlands.

Conditions

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Crohn Disease Colitis, Ulcerative Inflammatory Bowel Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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CD Participants

Participants diagnosed with CD from the 7 participating countries will take part in survey to collect data regarding their preferences towards the attributes of treatments based on DCE survey with advanced therapies for IBD, including safety and efficacy profiles, frequency and RoA in a real-world setting and data collection will be conducted in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international patient community.

No interventions assigned to this group

UC Participants

Participants diagnosed with UC from the 7 participating countries will take part in survey to collect data regarding theirpreferences towards the attributes of treatments based on DCE survey with advanced therapies for IBD, including safety and efficacy profiles, frequency and RoA in a real-world setting and data collection will be conducted in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international patient community.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1\. Self-reported suffering from CD or UC.

Exclusion Criteria

1\. Have never been ever treated with prescription medications for CD or UC.

* Should be included in the study only once.
* Data collected from participants who subsequently withdraw their consent will not be included in or will be deleted from the database.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Carenity

Paris, , France

Site Status

Countries

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France

Other Identifiers

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U1111-1259-3241

Identifier Type: REGISTRY

Identifier Source: secondary_id

IBD-5013

Identifier Type: -

Identifier Source: org_study_id

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