Crohn DiseaseNCT04597905
Paricipant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe
An observational study of Crohn Disease and Colitis, Ulcerative, run by Takeda at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
- How many people
- 686 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2020to 31 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants living with CD or UC, currently or previously treated for their condition.
Who may be able to join
- 1. Self-reported suffering from CD or UC.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Keywords
- Drug Therapy
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes after one time-survey start
Secondary outcomes (8)
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.
Measured: 20 minutes after one time-survey start
Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute
Measured: 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.
Measured: 20 minutes after one time-survey start
Percentage of CD and UC Participants who Switched Their Treatment
Measured: 20 minutes after one time-survey start
Percentage of CD and UC Participants who Switched Their Treatment due to Pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 20 minutes after one time-survey start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Oct 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597905
- Sponsor's protocol ID
- IBD-5013
- Other IDs
- U1111-1259-3241
- Status last verified
- Feb 2021
- First submitted
- 19 Oct 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04597905
- Acronym / sponsor ID
- IBD-5013
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants living with CD or UC, currently or previously treated for their condition.
Key inclusion criteria (1 listed)
- 1. Self-reported suffering from CD or UC.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Partworth Utilities for Subgroup Participants With CD and UC
Time frame: 20 minutes after one time-survey start
Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute
Time frame: 20 minutes after one time-survey start
Assessment of Latent Classes and Respective Partworth Utilities
Time frame: 20 minutes after one time-survey start
Percentage of CD and UC Participants who Switched Their Treatment
Time frame: 20 minutes after one time-survey start
Percentage of CD and UC Participants who Switched Their Treatment due to Pain
Time frame: 20 minutes after one time-survey start
Mean Evaluation of Preference Rating for Intravenous Infusion
Time frame: 20 minutes after one time-survey start
Mean Evaluation of Preference Rating for Subcutaneous (SC) Injection With Needle and Without Needle
Time frame: 20 minutes after one time-survey start
Mean Evaluation of Preference Rating For Oral Tablet or Pill
Time frame: 20 minutes after one time-survey start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Colitis, Ulcerative, run by Takeda at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partworth Utilities for Participants With CD and UC (time frame: 20 minutes after one time-survey start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.