UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015297
Receipt number R000017799
Scientific Title The feasibility study of accelated infliximab infusion from initial administration
Date of disclosure of the study information 2014/10/01
Last modified on 2020/04/06 22:21:58

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Basic information

Public title

The feasibility study of accelated infliximab infusion from initial administration

Acronym

The feasibility study of accelated infliximab infusion from initial administration

Scientific Title

The feasibility study of accelated infliximab infusion from initial administration

Scientific Title:Acronym

The feasibility study of accelated infliximab infusion from initial administration

Region

Japan


Condition

Condition

patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)

Classification by specialty

Medicine in general Gastroenterology Hematology and clinical oncology
Clinical immunology Dermatology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate feasibility of accelated infliximab infusion from the initial administration of infliximab

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The incidence of infusion reaction with 60min infliximab accelated infusion

Key secondary outcomes

discontinuous rate due to infusion reaction
success rate of rescue by usual 2hrs infusion after occurrence of infusion reaction
evaluation of premedication


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 Other

Interventions/Control_1

Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1)infliximab-initial administration case
2)Adequate organ fanction, no hematological disorder
3)Written informed consent

Key exclusion criteria

1)active serious infection
2)active tuberuculosis infection
3)allergy and/or hypersensitivity for mouse-derived protein
4)demyelinating disease(MS)
5)congestive heart failure
6)pregnant, nursing or likelihood of pregnancy woman
7)unable to birth control during and after 6 months from the latest infliximab administration
8)Not suitable for participating in the study for any other reason

Target sample size

54


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Takiguchi

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Medical Oncology

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba

TEL

043-222-7171

Email

takiguchi@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Takiguchi

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Medical Oncology

Zip code

260-8677

Address

1-8-1, Inohana, Chuo-ku, Chiba

TEL

043-222-7171

Homepage URL


Email

takiguchi@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Hospital

Address

1-8-1, Inohana, Chuo-ku, Chiba

Tel

043-222-7171

Email

chibacrc@mac.com


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

2014 Year 10 Month 01 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

Enrolling by invitation

Date of protocol fixation

2012 Year 08 Month 28 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 19 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 06 Month 30 Day

Date trial data considered complete

2016 Year 06 Month 30 Day

Date analysis concluded

2019 Year 04 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 09 Month 30 Day

Last modified on

2020 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017799


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name