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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597905
• Other study ID #: IBD-5013
• Secondary ID: U1111-1259-3241
• Status: Completed
• Start date: October 21, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 686
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
France	Carenity	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partworth Utilities for Participants With CD and UC	Partworth utilities (attribute importance scores and level values) will be evaluated separately for UC and CD in discrete choice experiment's (DCE) conditional logit (CL) models.DCEs:an attribute-based measure of benefit. CL model analyses DCEs.All DCE attributes will be included in CL models.For CD:remission after one year,occurrence of serious adverse effects or events,mild adverse effects or events, long-term remission on maintenance treatment and administration of medication.For UC: corticosteroid-free remission,healing of intestinal mucosa of bowel after one year,long-term remission on continuous treatment and administration of medication.All attributes will be coded as categorical variables;attribute levels will be dummy-coded,whereby omitted categories will be coded:0,omitted category for each attribute will be reference level of partworth utility.Negative partworth utility indicates less desired levels and positive partworth utility indicates more desired levels of attributes.	20 minutes after one time-survey start
Secondary	Partworth Utilities for Subgroup Participants With CD and UC	Partworth utilities for each pathology, by computing CL models on subgroup of participants based on demographic and medical profiles as well as quality of life criteria. Those subgroups will be created by using the clustering method available within the CL model, which will be conducted for each separated group and then compared using their estimated coefficients.	20 minutes after one time-survey start
Secondary	Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute		20 minutes after one time-survey start
Secondary	Assessment of Latent Classes and Respective Partworth Utilities	Latent classes and respective partworth utilities will be assessed by latent-class multinomial logit (LC-MNL) models. LC-MNL models will identify groups with similar preferences (latent classes), and estimate the probability that each respondent belongs to each class. Logistic regression models will then be applied to determine the association between latent class membership and participant characteristics.	20 minutes after one time-survey start
Secondary	Percentage of CD and UC Participants who Switched Their Treatment		20 minutes after one time-survey start
Secondary	Percentage of CD and UC Participants who Switched Their Treatment due to Pain		20 minutes after one time-survey start
Secondary	Mean Evaluation of Preference Rating for Intravenous Infusion	Rating for intravenous infusion will be evaluated from 0 to 100 range which signifies least to most preferred.	20 minutes after one time-survey start
Secondary	Mean Evaluation of Preference Rating for Subcutaneous (SC) Injection With Needle and Without Needle	Rating for SC injection will be evaluated from 0 to 100 range which signifies least to most preferred.	20 minutes after one time-survey start
Secondary	Mean Evaluation of Preference Rating For Oral Tablet or Pill	Rating for tablet/pills will be evaluated from 0 to 100 range which signifies least to most preferred.	20 minutes after one time-survey start