UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility study of accelated infliximab infusion during maintenance phase
Title of the study (Brief title)	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

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

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	Yuichi Takiguchi
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Oncology
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	043-222-7171
Email

Public contact
Name of contact person	Emiko Sakaida
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Medical Oncology
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009195