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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000007806
Date of registration: 01/05/2012
Prospective Registration: Yes
Primary sponsor: Chiba University Hospital
Public title: The feasibility study of accelated infliximab infusion during maintenance phase
Scientific title:
Date of first enrolment: 2012/06/01
Target sample size: 54
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009195
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Phase II
Countries of recruitment
Japan
Contacts
Name: Yuichi Takiguchi   
Address:  1-8-1, Inohana, Chuo-ku, Chiba Japan
Telephone: 043-222-7171
Email:
Affiliation:  Graduate School of Medicine, Chiba University Department of Medical Oncology
Name: Emiko Sakaida   
Address:  1-8-1, Inohana, Chuo-ku, Chiba Japan
Telephone: 043-222-7171
Email: esakaida@faculty.chiba-u.jp
Affiliation:  Graduate School of Medicine, Chiba University Department of Medical Oncology
Key inclusion & exclusion criteria
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

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


Age minimum: Not applicable
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)
Intervention(s)
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.
Primary Outcome(s)
The incidence of infusion reaction with 60min infliximab accelated infusion
Secondary Outcome(s)
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
Secondary ID(s)
Source(s) of Monetary Support
None
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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