UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063313 |
|---|---|
| Receipt number | R000072468 |
| Scientific Title | Study of Historical changes in treatment for patients with Inflammatory Bowel Disease: SHIFT-IBD |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 13:23:17 |
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Basic information
Public title
Study of Historical changes in treatment for patients with Inflammatory Bowel Disease: SHIFT-IBD
Acronym
Study of Historical changes in treatment for patients with Inflammatory Bowel Disease: SHIFT-IBD
Scientific Title
Study of Historical changes in treatment for patients with Inflammatory Bowel Disease: SHIFT-IBD
Scientific Title:Acronym
Study of Historical changes in treatment for patients with Inflammatory Bowel Disease: SHIFT-IBD
Region
| Japan |
Condition
Condition
Crohn's disease, Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify changes in the use of IBD treatments, with a focus on Advanced Therapies (AT), in Japan.
Basic objectives2
Others
Basic objectives -Others
To determine whether there have been changes in IBD outcomes, such as hospitalization rates, intestinal resection rates, and the incidence of IBD-related cancers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual Rates of Medication Use, Hospitalization, and Intestinal Resection, and Changes Over Time
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) between 2005 and 2025 in the JMDC (Japan Medical Data Center) Social Insurance Claims Database
Key exclusion criteria
None
Target sample size
48000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Suzuki |
Organization
EA Pharma Co., Ltd.
Division name
Medical Department, Medical Science Group
Zip code
104-0042
Address
2-1-1 Irifune, Chuo-ku, Tokyo
TEL
080-1060-3254
takahirob_suzuki@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Suzuki |
Organization
EA Pharma Co., Ltd.
Division name
Medical Department, Medical Science Group
Zip code
104-0042
Address
2-1-1 Irifune, Chuo-ku, Tokyo
TEL
080-1060-3254
Homepage URL
takahirob_suzuki@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic Research Ethics Committee
Address
1-15-9 Jiyugaoka, Meguro-ku, Tokyo
Tel
03-6777-1490
c-irb_ug@neues.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
| 2026 | Year | 10 | Month | 16 | 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
| 2026 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072468
