UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis
Title of the study (Brief title)	Efficacy and safety of IFX-BS in UC patients
Region	Japan

Condition
Condition	ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To show the efficacy and safety of biosimilar Infliximab in the patients with ulcerative colitis 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 partial Mayo's score 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 (5mg/kg, every 8 weeks, for 12 months)
Interventions/Control_2	Biosimilar Infliximab (5mg/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 ulcerative colitis treated with Infliximab 2) Being in the clinical remission state (partial Mayo's score <2, 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	20

Research contact person
Name of lead principal investigator	Sohachi Nanjo
Organization	University of Toyama
Division name	Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences
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	Sohachi Nanjo
Organization	University of Toyama
Division name	Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc
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)

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 05 Month 24 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 29 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 23 Day
Last modified on	2018 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031466