UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043165 |
|---|---|
| Receipt number | R000049209 |
| Scientific Title | Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2021/01/28 14:53:45 |
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Basic information
Public title
Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease
Acronym
Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease
Scientific Title
Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease
Scientific Title:Acronym
Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease
Region
| Japan |
Condition
Condition
Crohn's disease, Ulcerative colitis, IBDU
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse events
Key secondary outcomes
efficacy, cumulative continuation rate, risk factors for relapse, risk factors for adverse events, questionnaire survey, efficacy of infliximab biosimilar CT-P13 by trough of originator infliximab before switch
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
| Medicine |
Interventions/Control_1
witching from originator infliximab to infliximab biosimilar CT-P13
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
1. Patients who will switch from originator infliximab to infliximab biosimilar CT-P13
2. Patients with consent to participate
Key exclusion criteria
1. Patients who don't consent
2. Patients who are judged not suitable for this trial by the doctor
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Hisabe |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin Chikushino Fukuoka, Japan
TEL
092-921-1011
hisabe@cis.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Teruyuki |
| Middle name | |
| Last name | Takeda |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Gastroenterology
Zip code
8188502
Address
1-1-1 Zokumyoin Chikushino Fukuoka, Japan
TEL
092-921-1011
Homepage URL
take5times@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Fukuoka University Facility of Medicine, Fukuoka
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
Fukuoka University Chikushi Hospital
Address
1-1-1 Zokumyoin, Chikushino City, Fukuoka, Japan
Tel
092-921-1011
chikushirinsho@adm.fukuoka-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
| 2021 | Year | 01 | Month | 31 | 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
| 2021 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | 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
| 2021 | Year | 01 | Month | 28 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049209
