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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026330
Receipt No. R000030245
Scientific Title Efficacy and safety of the biosimilar Infliximab in the patients with Crohn's disease
Date of disclosure of the study information 2017/02/28
Last modified on 2020/09/01

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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 No longer recruiting
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
2020 Year 09 Month 01 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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