UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027465
Receipt number R000031466
Scientific Title Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis
Date of disclosure of the study information 2017/05/24
Last modified on 2018/05/23 13:03:11

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Basic information

Public title

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis

Acronym

Efficacy and safety of IFX-BS in UC patients

Scientific Title

Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis

Scientific Title:Acronym

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

1st name
Middle name
Last name Sohachi Nanjo

Organization

University of Toyama

Division name

Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences

Zip code


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
Middle name
Last name Sohachi Nanjo

Organization

University of Toyama

Division name

Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc

Zip code


Address

Sugitani 2630, Toyama City, Toyama Prefecture, Japan

TEL

076-434-7301

Homepage URL


Email

snanjo@med.u-toyama.ac.jp


Sponsor or person

Institute

University of Toyama

Institute

Department

Personal name



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


Address


Tel


Email



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


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

Terminated

Date of protocol fixation

2017 Year 05 Month 01 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name