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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1259-3241 | Registry Identifier | WHO |
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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.
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:
This multi-center trial will be conducted in France, the United Kingdom, Italy, Spain, Belgium, Switzerland, the Netherlands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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Participants living with CD or UC, currently or previously treated for their condition.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carenity | Paris | 75008 | France |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| 20 minutes after one time-survey start |
| Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute | 20 minutes after one time-survey start |
| 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 |
| Percentage of CD and UC Participants who Switched Their Treatment | 20 minutes after one time-survey start |
| Percentage of CD and UC Participants who Switched Their Treatment due to Pain | 20 minutes after one time-survey start |
| 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 |
| 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 |
| 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 |
| D003092 | Colitis |
| D003108 | Colonic Diseases |