UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059341 |
|---|---|
| Receipt number | R000067805 |
| Scientific Title | A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP) |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/09 12:10:42 |
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Basic information
Public title
A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)
Acronym
RISE UP study
Scientific Title
A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)
Scientific Title:Acronym
RISE UP study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The clinical effectiveness of risankizumab in patients with moderate to severe ulcerative colitis in real-world clinical practice
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement of clinical remission per Partial Adapted Mayo Score at Week 52
Key secondary outcomes
-Achievement of no BU, AP, NBM, FI, SI, tenesmus.
-Achievement of clinical response and clinical remission per Partial Adapted Mayo Score.
-Achievement of endoscopic improvement and remission.
-Achievement of clinical remission per Adapted Mayo Score.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Male or female patients 15 years of age or older.
-Participants with a diagnosis of moderate to severe UC commenced on Risankizumab treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations/guidelines.
-The decision to prescribe RZB is made prior to and independently of study participation.
-Participants able to provide voluntary informed consent before any study-related activities or procedures. If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent.
-Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone).
-Participants without previous exposure to RZB.
-Participants who are not currently participating in interventional research.
Key exclusion criteria
No formal Exclusion criteria exist
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tadakazu |
| Middle name | |
| Last name | Hisamatsu |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
Shinkawa 6-20-2, Mitaka-shi, Tokyo, Japan
TEL
0422-47-5511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | AbbVie GK Clinical Trial Registration Desk |
| Middle name | |
| Last name | - |
Organization
AbbVie GK
Division name
Medical Affairs
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-4577-1111
Homepage URL
abbvie_jpn_info_clingov@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital IRB
Address
5-9-1, Shirokane, Minato-ku, Tokyo, Japan
Tel
03-3444-6161
jaken1013@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT07136116
Org. issuing International ID_1
ClinicalTraial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a real-world, prospective, single country, post-marking observational study. The population of this study is adult patients with diagnosis of UC commenced on RZB treatment prescribed as part of their routine clinical care at their clinician's discretion according to locally approved label and local treatment prescription recommendations/guidelines.
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067805
