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Recruitment status Completed
Unique ID issued by UMIN UMIN000007806
Receipt No. R000009195
Scientific Title The feasibility study of accelated infliximab infusion during maintenance phase
Date of disclosure of the study information 2012/05/01
Last modified on 2018/10/06

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Basic information
Public title The feasibility study of accelated infliximab infusion during maintenance phase
Acronym The feasibility study of accelated infliximab infusion during maintenance phase
Scientific Title The feasibility study of accelated infliximab infusion during maintenance phase
Scientific Title:Acronym The feasibility study of accelated infliximab infusion during maintenance phase
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 in the maintenance treatment
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 1) patients preference
2) discontinuous rate due to infusion reaction
3) success rate of rescue by usual 2hrs infusion after occurrence of infusion reaction
4) evaluation of premedication

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)infliximab-maintenance treatment adequate case, who are already successfully administrated with usual 2hr infuion without infusion reaction at three and more initial treatment.
2)Adequate organ fanction, no hematological disorder
3)Written informed consent
Key exclusion criteria 1)active serious infection
2)active tuberuculosis infection
3)past history of bronchial asthma
4)past history of hypersensitivity reaction and/or allergy for any drugs and food
5)allergy and/or hypersensitivity for mouse-derived protein
6)demyelinating disease(MS)
7)congestive heart failure
8)pregnant, nursing or likelihood of pregnancy woman
9)unable to birth control during and after 6 months from the latest infliximab administration
10)past treatment history with infliximab and readministration at an interval of over three months
11)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
Middle name
Last name Yuichi Takiguchi
Organization Graduate School of Medicine, Chiba University
Division name Department of Medical Oncology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Emiko Sakaida
Organization Graduate School of Medicine, Chiba University
Division name Department of Medical Oncology
Zip code
Address 1-8-1, Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email esakaida@faculty.chiba-u.jp

Sponsor
Institute Chiba University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
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
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 千葉大学医学部附属病院 Chiba University Hospital

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2012 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 12 Month 01 Day
Date analysis concluded
2015 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 21 Day
Last modified on
2018 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009195


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