UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046650 |
|---|---|
| Receipt number | R000053213 |
| Scientific Title | exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis |
| Date of disclosure of the study information | 2022/01/18 |
| Last modified on | 2022/01/16 09:57:20 |
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Basic information
Public title
exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Acronym
exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Scientific Title
exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Scientific Title:Acronym
exploratory study of optimizing ustekinumab dosing interval in ulcerative colitis
Region
| Japan |
Condition
Condition
ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether endoscopic mucosal healing can be used to determine the optimization of ustekinumab dosing intervals in patients with ulcerative colitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
endoscopic therapeutic effects and clinical findings after UST administration at week 28 to 32.
Key secondary outcomes
Lichtiger index, white blood cells, platelets, albumin, C-reactive protein, erythrocyte sedimentation rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopy was performed 28 to 32 weeks after the administration of ustekinumab
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 20 years or older at the time of obtaining the consent form.
2. Patients with ulcerative colitis who received ustekinumab.
3. Ulcers that have already started treatment with ustekinumab but have not undergone endoscopy after treatment within 24 weeks
Key exclusion criteria
1.Patients judged by the principal investigator to be inappropriate as subjects
2.Patients without discernment
3.Patients who cannot obtain written consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUKA |
| Middle name | |
| Last name | FUKUO |
Organization
JUNTENDO UNIVERSITY NERIMA HOSPITAL
Division name
Gastroenterology
Zip code
1778521
Address
3-1-10 Takanodai Nerima-ku Tokyo
TEL
03-5923-3111
yfukuo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | YUKA |
| Middle name | |
| Last name | FUKUO |
Organization
JUNTENDO UNIVERSITY NERIMA HOSPITAL
Division name
Gastroenterology
Zip code
1778521
Address
3-1-10 Takanodai Nerima-ku Tokyo
TEL
03-5923-3111
Homepage URL
yfukuo@juntendo.ac.jp
Sponsor or person
Institute
JUNTENDO UNIVERSITY NERIMA HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
nothing
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
JUNTENDO UNIVERSITY NERIMA HOSPITAL
Address
3-1-10 Takanodai Nerima-ku Tokyo
Tel
0359233111
yfukuo@juntendo.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
| 2022 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2020 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 16 | Day |
Last modified on
| 2022 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053213
