UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041774 |
|---|---|
| Receipt number | R000047680 |
| Scientific Title | Efficacy of STELARA (ustekinumab) with ulcerative colitis: multicenter prospective observational study -KDOG UC-UST STUDY- |
| Date of disclosure of the study information | 2020/09/13 |
| Last modified on | 2024/10/06 00:57:43 |
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Basic information
Public title
Efficacy of STELARA (ustekinumab) with ulcerative colitis: multicenter prospective observational study -KDOG UC-UST STUDY-
Acronym
KDOG UC-UST STUDY
Scientific Title
Efficacy of STELARA (ustekinumab) with ulcerative colitis: multicenter prospective observational study -KDOG UC-UST STUDY-
Scientific Title:Acronym
KDOG UC-UST STUDY
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of ustekinumab in patients with ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical remission rate at 1 year (56 weeks) after starting treatment with ustekinumab
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) Patients who met the criteria for ulcerative colitis, outpatients and inpatients
2) Active patients who are inadequate for existing treatments
3) Patients over 16 years old
4) Patients who have consent for this study
Key exclusion criteria
1) Patients participating in clinical trials of other new drugs
2) Patients with a history of ustekinumab
3) Patients with previous colorectal surgery
4) Patients with serious infections
5) Patients with active tuberculosis
6) Patients with a history of hypersensitivity to any of the ingredients in ustekinumab
7) Patients undergoing treatment for malignancy
8) Patients who are pregnant at the start of treatment
9) Patients deemed ineligible by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Yokoyama |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami, Sagamihara Kanagawa
TEL
042-778-8111
kaoru.y@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Yokoyama |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami, Sagamihara Kanagawa
TEL
042-778-8111
Homepage URL
kaoru.y@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine
Address
1-15-1 Kitasato Minami, Sagamihara Kanagawa
Tel
042-778-8111
rinrib@med.kitasato-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
| 2020 | Year | 09 | Month | 13 | 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
31
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the extended case registration period.
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
prospective observational study
Patients with ulcerative colitis started on ustekinumab at Kitasato University Hospital and related hospitals
Management information
Registered date
| 2020 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047680
