UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease
Acronym	Efficacy and safety of IFX-BS in CD patients
Scientific Title	Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease
Scientific Title:Acronym	Efficacy and safety of IFX-BS in CD patients
Region	Japan

Condition
Condition	Crohn disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To show the efficacy and safety of biosimilar Infliximab in the patients with Crohn disease in the remission state by the maintenance therapy of Infliximab.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The remission rate and the adverse events 24 and 48 weeks after the switch from infliximab to its biosimilar
Key secondary outcomes	The value of clinical disease activity index The value of serum CRP The value of serum albumin The value of hemoglobin The increase of Infliximab or biosimilar Infliximab

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
Interventions/Control_2	Biosimilar Infliximab (5 or 10mg/kg, every 8 weeks, for 12 months)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with Crohn disease treated with Infliximab 2) Being in the clinical remission state (CDAI <150, and CRP < 0.5mg/dl)
Key exclusion criteria	1) Patients younger than 20 years old 2) Patients keeping in the clinical remission state for more than 10 years
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Sohachi Middle name Last name Nanjo
Organization	University of Toyama
Division name	Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences
Zip code	930-0194
Address	Sugitani 2630, Toyama City, Toyama Prefecture, Japan
TEL	076-434-7301
Email	snanjo@med.u-toyama.ac.jp

Public contact
Name of contact person	1st name Sohachi Middle name Last name Nanjo
Organization	University of Toyama
Division name	Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc
Zip code	930-0194
Address	Sugitani 2630, Toyama City, Toyama Prefecture, Japan
TEL	076-434-7301
Homepage URL
Email	snanjo@med.u-toyama.ac.jp

Sponsor
Institute	University of Toyama
Institute
Department

Funding Source
Organization	plural commercial corporations
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Clinical Research, Toyama University Hospital
Address	Sugitani 2630, Toyama city, Toyama Prefecture, Japan
Tel	076-434-2281
Email	yuka@adm.u-toyama.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	2017 Year 02 Month 28 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	18
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The delay of the data analysis
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	Completed
Date of protocol fixation	2017 Year 02 Month 27 Day
Date of IRB	2017 Year 02 Month 27 Day
Anticipated trial start date	2017 Year 02 Month 27 Day
Last follow-up date	2018 Year 07 Month 30 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 28 Day
Last modified on	2022 Year 09 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030245