UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043165
Receipt number R000049209
Scientific Title Safety and efficacy of non-medical switching from originator infliximab to infliximab biosimilar CT-P13 in patients with inflammatory bowel disease
Date of disclosure of the study information 2021/01/31
Last modified on 2021/01/28 14:53:45

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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 or person

Institute

Fukuoka University Chikushi Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049209


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name