UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052327 |
|---|---|
| Receipt number | R000059675 |
| Scientific Title | Relationship between patient decision-making on advanced therapies and patient background in patients with ulcerative colitis |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2024/11/13 17:18:47 |
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Basic information
Public title
Relationship between patient decision-making on advanced therapies and patient background in patients with ulcerative colitis
Acronym
Relationship between patient decision-making on advanced therapies and patient background in patients with ulcerative colitis
Scientific Title
Relationship between patient decision-making on advanced therapies and patient background in patients with ulcerative colitis
Scientific Title:Acronym
Relationship between patient decision-making on advanced therapies and patient background in patients with ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis (UC)
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A web-based questionnaire survey is conducted in patients with ulcerative colitis and a conjoint analysis is performed to clarify the relationship between important drug profiles on patient decision-making of advanced therapies and patients background.
Basic objectives2
Others
Basic objectives -Others
The results of this study are expected to support shared decision making in selecting the optimal treatment tailored to individual work status and life events.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Importance of drug profiles (mode of administration, efficacy, adverse events, and timing of launches) by patient background (demographics, disease activity, treatment of UC, employment status, status of employees, status of students, and other life events)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants are recruited from the inflammatory bowel disease (IBD) patient panel (IBD+) developed and maintained by QLife, Inc.
All of the following inclusion criteria 1-4
1) age 18 years or older
2) diagnosis of UC
3) history of oral 5-aminosalicylates
4) agreement to participate and informed consent provision on the survey study website
Key exclusion criteria
No matching the key inclusion criteria
Participants who expressed nonparticipation in the study prior to data fixation
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Mizuno |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Development & Medical Affairs Division
Zip code
100-8205
Address
1-1-1 Marunouchi, Chiyoda-ku, Tokyo
TEL
03-6748-7700
rpp_mtpc@cc.mt-pharma.co.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Kitahara |
Organization
QLife, Inc.
Division name
Strategic Solution Planning & Development Dept
Zip code
105-0001
Address
Toranomon 33 Mori Bldg. 10F, 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
03-6860-5020
Homepage URL
office_2@qlife.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharma Corporation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Janssen Pharmaceutical K. K.
IRB Contact (For public release)
Organization
Ethical Review Committee for Human Tissue Research, etc. of Mitsubishi Chemical Group Corporation
Address
1-1-1 Marunouchi, Chiyoda-ku, Tokyo
Tel
080-1068-8472
mitubishi-tanabe-pharma_erb@ml.mt-pharma.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000059675
Publication of results
Published
Result
URL related to results and publications
https://irjournal.org/journal/view.php?doi=10.5217/ir.2024.00101
Number of participants that the trial has enrolled
365
Results
This study examined UC patients' preferences for advanced therapy drug profiles using a web-based survey.
The survey involved 365 patients who had previously used oral 5-ASA.
The most important profile for patients was the route/frequency of administration, especially in mild symptom scenarios where oral administration was preferred.
In severe symptom scenarios, the speed of onset of action became more important.
Preferences did not significantly differ between employed and unemployed patients.
Results date posted
| 2024 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of the patients was 42.9 years, and 66.6% were women. The mean disease duration was 9.2 years, and 55.9% had pancolitis. Prior medications included topical 5-ASA/steroid (77.8%), oral/injectable steroids (66.3%), thiopurines (37.0%), and advanced therapies (46.3%). 73.2% of patients were employed, of whom 58.8% were permanent employees.
Participant flow
Participants were recruited from the IBD patient panel of QLife, Inc. The inclusion criteria were UC patients aged 18 years and over who were previously treated with oral 5-ASA and willing to provide informed consent to participate in this survey. In the screening survey, age, disease name, and experience with drugs for UC treatment were investigated, and the respondents who met the inclusion criteria proceeded to this survey.
Adverse events
Not collected
Outcome measures
Conjoint analysis:
-The most important drug profile was the route/frequency of administration in both mild and severe symptom scenarios.
-Although oral administration was preferred in the mild symptom scenario, there was no trend toward specific route/frequency of administration in the severe symptom scenario.
-In severe symptom scenarios, the speed of onset of action became more important.
-Preferences did not significantly differ between employed and unemployed patients.
Multiple regression analysis:
-It was suggested that patient preferences were varied among individual patients.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 07 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 07 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 17 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 28 | Day |
Other
Other related information
None in particular
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059675
