UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044286 |
|---|---|
| Receipt number | R000050582 |
| Scientific Title | Evaluation of persistence and safety in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with ulcerative colitis |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/12/20 18:19:31 |
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Basic information
Public title
Evaluation of persistence and safety in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with ulcerative colitis
Acronym
UC-EXTEND Study
Scientific Title
Evaluation of persistence and safety in extending of injection period of ustekinumab from every 8 to 12 weeks in patients with ulcerative colitis
Scientific Title:Acronym
UC-EXTEND Study
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Persistence and safety of switching ustekinumab maintenance therapy every 8 to 12 weeks in UC patients with clinical remission 26weeks and more.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Persistence rate until 1 year
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
UC patients with clinical remission treated by ustekinumab 90mg subcutaneous every 8 weeks
Key exclusion criteria
Patients of contraindication of ustekinumab
Patients with pregnancy or lactating
Patients without informed consent
Patients with previous or ongoing malignancy
Patients with colectomy
Patients who is not appropriate for this study
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
3508550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
0492283564
katoshin007@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kato |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
3508550
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
TEL
0492283564
Homepage URL
skato@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical 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
IRB of Saitama Medical Center
Address
1981, Kamoda, Kawagoe City, Saitama, Japan
Tel
049-228-3902
smcrinri@saitama-med.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
| 2021 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Intermediate analysis will be performed at the timing of entry of 10 and more patients. Finally this study will be continued until 3 years. However, we will make presentations in scientific meetings and/or published paper about the data until 1 year.
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2021 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050582
