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Completed

NCT Number: NCT04597905

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

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.

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Key information

Conditions

Crohn Disease Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Carenity

Paris, 75008, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-reported suffering from CD or UC.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Partworth Utilities for Participants With CD and UC

    Time frame: 20 minutes after one time-survey start

    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.

Secondary outcomes

  1. Partworth Utilities for Subgroup Participants With CD and UC

    Time frame: 20 minutes after one time-survey start

    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.

  2. Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute

    Time frame: 20 minutes after one time-survey start

  3. Assessment of Latent Classes and Respective Partworth Utilities

    Time frame: 20 minutes after one time-survey start

    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.

  4. Percentage of CD and UC Participants who Switched Their Treatment

    Time frame: 20 minutes after one time-survey start

  5. Percentage of CD and UC Participants who Switched Their Treatment due to Pain

    Time frame: 20 minutes after one time-survey start

  6. Mean Evaluation of Preference Rating for Intravenous Infusion

    Time frame: 20 minutes after one time-survey start

    Rating for intravenous infusion will be evaluated from 0 to 100 range which signifies least to most preferred.

  7. Mean Evaluation of Preference Rating for Subcutaneous (SC) Injection With Needle and Without Needle

    Time frame: 20 minutes after one time-survey start

    Rating for SC injection will be evaluated from 0 to 100 range which signifies least to most preferred.

  8. Mean Evaluation of Preference Rating For Oral Tablet or Pill

    Time frame: 20 minutes after one time-survey start

    Rating for tablet/pills will be evaluated from 0 to 100 range which signifies least to most preferred.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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