UMIN-CTR Clinical Trial

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
Email	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
Email	take5times@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Chikushi Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049209