UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056622 |
|---|---|
| Receipt number | R000064690 |
| Scientific Title | Switching from originator adalimumab to biosimilar (CT-P17) in patients with inflammatory bowel disease (SORATOBI study) |
| Date of disclosure of the study information | 2025/01/04 |
| Last modified on | 2025/01/03 19:36:14 |
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Basic information
Public title
Switching from originator adalimumab to biosimilar (CT-P17) in patients with inflammatory bowel disease (SORATOBI study)
Acronym
SORATOBI study
Scientific Title
Switching from originator adalimumab to biosimilar (CT-P17) in patients with inflammatory bowel disease (SORATOBI study)
Scientific Title:Acronym
SORATOBI study
Region
| Japan |
Condition
Condition
Inflammatory bowel disease (Ulcerative colitis, Crohn's disease)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of switching from the adalimumab originator to the biosimilar (CT-P17) in patients with inflammatory bowel disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The continuation rate of adalimumab biosimilar (CT-P17) at 56 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with inflammatory bowel disease (ulcerative colitis, Crohn's disease) undergoing maintenance treatment with adalimumab originator
2) Patients who have been definitively diagnosed with inflammatory bowel disease (ulcerative colitis or Crohn's disease) according to the Japanese diagnostic criteria
3) Patients aged 18 years or older (if under 20 years old, consent from a legal representative must also be obtained)
4) Patients scheduled to switch to adalimumab biosimilar (CT-P17)
5) Patients who have obtained written consent for this study
Key exclusion criteria
No regulations
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo IBD Clinic
Division name
Director
Zip code
064-0919
Address
Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN
TEL
+81-11-213-0397
hirokit@mtc.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Tanaka |
Organization
Sapporo IBD Clinic
Division name
Director
Zip code
064-0919
Address
Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN
TEL
+81-11-213-0397
Homepage URL
hirokit@mtc.biglobe.ne.jp
Sponsor or person
Institute
Sapporo IBD Clinic
Institute
Department
Personal name
Funding Source
Organization
Sapporo IBD Clinic
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
Sapporo IBD Clinic Ethics Committee
Address
Yamahana Doctor Town F2, 1-18, Minami-19, Nishi-8, Chuo-ku, Sapporo, HOKKAIDO, 064-0919, JAPAN
Tel
011-231-0397
hirokit@mtc.biglobe.ne.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
| 2025 | Year | 01 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064690
