Clinical trial NCT04597905: Paricipant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe
Official title: Observational Study to Define Patient Preferences Toward the Attributes of Treatment Used for Inflammatory Bowel Disease, Including Efficacy Profile, Safety Profile, Frequency and Route of Administration, in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Diseases
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 686
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants living with CD or UC, currently or previously treated for their condition.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Partworth Utilities for Participants With CD and UC
timeFrame: 20 minutes after one time-survey start
Secondary outcomes:
measure: Partworth Utilities for Subgroup Participants With CD and UC
timeFrame: 20 minutes after one time-survey start
measure: Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute
timeFrame: 20 minutes after one time-survey start
measure: Assessment of Latent Classes and Respective Partworth Utilities
timeFrame: 20 minutes after one time-survey start
measure: Percentage of CD and UC Participants who Switched Their Treatment
timeFrame: 20 minutes after one time-survey start
measure: Percentage of CD and UC Participants who Switched Their Treatment due to Pain
timeFrame: 20 minutes after one time-survey start
measure: Mean Evaluation of Preference Rating for Intravenous Infusion
timeFrame: 20 minutes after one time-survey start
measure: Mean Evaluation of Preference Rating for Subcutaneous (SC) Injection With Needle and Without Needle
timeFrame: 20 minutes after one time-survey start
measure: Mean Evaluation of Preference Rating For Oral Tablet or Pill
timeFrame: 20 minutes after one time-survey start
Other outcomes:
Locations:
city: Paris
country: France
facility: Carenity
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: