UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007806 |
|---|---|
| Receipt number | 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 07:55:21 |
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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
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
| 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
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
esakaida@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009195
