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

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT04597905

U1111-1259-3241 (Registry Identifier)

IBD-5013

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 686 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

686 participants in 2 patient groups

CD Participants

Description:

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.

UC Participants

Description:

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.