UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053025 |
|---|---|
| Receipt number | R000060488 |
| Scientific Title | Efficacy and Safety of biosimilar to Crohn's disease and ulcerative colitis: prospective cohort observational study |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/01/05 09:03:00 |
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Basic information
Public title
Efficacy and Safety of biosimilar to Crohn's disease and ulcerative colitis: prospective cohort observational study
Acronym
IBD biosimilar study
Scientific Title
Efficacy and Safety of biosimilar to Crohn's disease and ulcerative colitis: prospective cohort observational study
Scientific Title:Acronym
IBD biosimilar study
Region
| Japan |
Condition
Condition
Crohn's disease and ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of biosimilar for inflammatory bowel disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical remission rate after 1 year and 3 years
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
Crohn's disease or ulcerative colitis patients treated or scheduled to start Infliximab or Adalimumab
Key exclusion criteria
1. Patients without definite diagnosis of Crohn's disease or ulcerative colitis.
2. Patients who have previously received either Infliximab BS or Adalimumab BS.
3. Patients who are judged by the researchers to be unsuitable as research subjects.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimodate |
Organization
Kurashiki Central Hospital
Division name
Center for IBD
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
ys13544@kchnet.or.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimodate |
Organization
Kurashiki Central Hospital
Division name
Center for IBD
Zip code
710-8602
Address
Miwa 1-1-1, Kurashiki, Okayama
TEL
086-422-0210
Homepage URL
ys13544@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Clinical Research Institute, Kurashiki Central Hospital
Address
Miwa 1-1-1, Kurashiki, Okayama
Tel
086-422-0210
kurari-net@kchnet.or.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
| 2023 | Year | 12 | Month | 07 | 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
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Survey will be conducted at the visit to the hospital 2 months, 6 months, 1 year, 2 years, and 3 years after starting treatment or switching.
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060488
