UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053935 |
|---|---|
| Receipt number | R000061560 |
| Scientific Title | Exploring of factors contributing to the efficacy of adhesion molecule inhibitors for ulcerative colitis: a multi-center study in Japan |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2025/04/10 09:04:00 |
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Basic information
Public title
Exploring factors contributing to the efficacy of adhesion molecule inhibitors for ulcerative colitis: a multi-center study in Japan
Acronym
FAMILIA Study
Scientific Title
Exploring of factors contributing to the efficacy of adhesion molecule inhibitors for ulcerative colitis: a multi-center study in Japan
Scientific Title:Acronym
FAMILIA Study
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore factors contributing to the clinical efficacy of adhesion molecule inhibitors for ulcerative colitis by analyzing the impacts of those medications on immune cells in the blood and intestine and prospectively investigating the relations between these immunological influence and clinical course of ulcerative colitis.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exploring the factors related to the endoscopic improvement at 6 months after starting the remission induction therapy.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Subjects diagnosed with ulcerative colitis.
(2)Subjects who are naive to molecular-targeted medications and plan to start adhesion molecule inhibitors.
(3)Subjects who are 16 years old or older when providing written consent.
(4)Subjects who understand, decide to take part in this study and provide written consent by themselves. Minors need consent from themselves as well as their guardians.
Key exclusion criteria
(1)Subjects who don't provide written consent by themselves or their guardians.
(2)Subjects who had total or partial colectomy.
(3)Subjects diagnosed with proctitis or an undetermined disease type.
(4)Subjects suspected concomitant colitis due to other reasons.
(5)Subjects with an emergent, critical condition of ulcerative colitis (e.g., fulminant UC, toxic megacolon, uncontrollable bleeding).
Target sample size
10
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
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Miyoshi |
Organization
Kyorin University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
jmiyoshi@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding
EA Pharma Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sapporo Medical University, Dept. Gastroenterology and Hepatology
Toho University Sakura Medical Center, Dept. Gastroenterology and Hepatology
Kitasato University Kitasato Institute Hospital, Dept. Gastroenterology and Hepatology
Name of secondary funder(s)
EA Pharma Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Kyorin University School of Medicine Research Ethics Committee
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-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
杏林大学医学部（東京都）、札幌医科大学（北海道）、東邦大学医療センター佐倉病院（千葉県）、北里大学北里研究所病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 01 | 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 | 01 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
This observational study aims to explore factors contributing to the clinical efficacy of adhesion molecule inhibitors for ulcerative colitis by analyzing the impacts of those medications on immune cells in the blood and intestine and prospectively investigating the relations between these immunological influence and clinical course of ulcerative colitis.
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061560
