UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055475 |
|---|---|
| Receipt number | R000063372 |
| Scientific Title | Multicenter Registry Study on the Efficacy and Safety of Anti-IL-23p19 Antibodies for Ulcerative Colitis |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2024/09/10 21:50:15 |
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Basic information
Public title
Multicenter Registry Study on the Efficacy and Safety of Anti-IL-23p19 Antibodies for Ulcerative Colitis
Acronym
QUALT19 Registry
Scientific Title
Multicenter Registry Study on the Efficacy and Safety of Anti-IL-23p19 Antibodies for Ulcerative Colitis
Scientific Title:Acronym
QUALT19 Registry
Region
| Japan |
Condition
Condition
Ulcerative Colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ulcerative colitis (UC), a subset of inflammatory bowel disease (IBD), is characterized by chronic recurrent intestinal inflammation. UC is thought to develop as a result of interactions between genetic susceptibility and environmental factors. Once diagnosed, long-term management of disease activity through continuous medical treatment is crucial.
While treatment guidelines for UC have been established by the Intractable Intestinal Disorder Research Group in Japan, clinicians often face challenges in drug selection. The recent introduction of various biological agents and small molecule compounds has further complicated this process. Given the high cost of these medications, appropriate patient selection is imperative from a health economics perspective. Randomized controlled trials and meta-analyses have reported on the efficacy of biologics and small molecule compounds for IBD, as well as predictors of treatment response. However, these studies often involve patients with specific clinical profiles, potentially leading to discrepancies between trial results and real-world clinical outcomes. Consequently, there has been renewed interest in analyses based on real-world clinical data. In Europe, IBD patient registries have been established, facilitating rapid reporting on the effectiveness and safety of biologics and small molecule compounds in real-world settings, significantly contributing to clinical decision-making. This study focuses specifically on UC within the broader context of IBD. Our primary objective is to evaluate the efficacy of anti-IL-23p19 antibodies and identify predictors of treatment response in UC patients treated at Saga University's division of Gastroenterology and participating institutions across Kyushu in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical remission at 4 weeks, 12 weeks, 28 weeks, and 52 weeks after initiation of treatment
Key secondary outcomes
Rates of clinical improvement, achievement of steroid-free remission, changes in quality of life (QOL), rates of biomarker remission, and incidence of adverse events at 4 weeks, 12 weeks, 28 weeks, and 52 weeks after treatment initiation
Rate of endoscopic remission at 52 weeks
Analysis of factors contributing to successful induction and maintenance of remission
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
Patients diagnosed with ulcerative colitis (UC) and receiving treatment with anti-IL-23p19 antibodies at Saga University Hospital and affiliated research institutions from the date of approval notification issuance to March 31, 2027.
Patients aged 18 years or older.
Patients under 18 years of age with consent obtained from their legal representatives.
Key exclusion criteria
Individuals who do not consent to the purpose of this observational study.
Cases where the attending physician determines that participation in the research is inappropriate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Esaki |
| Middle name | |
| Last name | Motohiro |
Organization
Saga University
Division name
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine
Zip code
8498501
Address
Nabeshima5-1-1, Saga-City, Saga-Prefecture, Japan.
TEL
0952-31-6511
mesaki01@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Sadashima |
| Middle name | |
| Last name | Kento |
Organization
Saga University
Division name
Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine
Zip code
8498501
Address
Nabeshima5-1-1, Saga-City, Saga-Prefecture, Japan.
TEL
0952-31-6511
Homepage URL
s_kent66@yahoo.co.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Esaki Motohiro
Funding Source
Organization
Saga University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University Clinical Research Review Board
Address
Nabeshima5-1-1, Saga-City, Saga-Prefecture, Japan.
Tel
0952-34-3357
crb@mail.admin.saga-u.ac.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
| 2024 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter prospective registry focused on evaluating the treatment effectiveness and safety of molecular-targeted drugs and small molecules in patients with ulcerative colitis (UC). Data will be collected from various facilities, including detailed patient information, clinical outcomes, and quality of life (QOL) metrics using the IBDQ score. This study involves collaboration between several university hospitals and clinics across Kyushu, Japan. Additionally, this research aims to investigate treatment predictors and explore differences in treatment response among various drugs, specifically focusing on Mirikizumab and Risankizumab.
The study also adheres to ethical guidelines such as the Helsinki Declaration and Japan's Ethical Guidelines for Medical and Health Research Involving Human Subjects. All personal data will be pseudonymized and stored securely, and no identifiable information will be shared between institutions without proper consent. Research results will be disseminated through academic journals and conferences, contributing to the ongoing development of clinical strategies for UC.
Management information
Registered date
| 2024 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063372
