UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014311 |
|---|---|
| Receipt number | R000016664 |
| Scientific Title | Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis |
| Date of disclosure of the study information | 2014/06/24 |
| Last modified on | 2014/06/19 00:26:17 |
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Basic information
Public title
Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis
Acronym
Examination of the clinical remission and functional remission in Infliximab using an increase-in-quantity protocol
Scientific Title
Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis
Scientific Title:Acronym
Examination of the clinical remission and functional remission in Infliximab using an increase-in-quantity protocol
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the clinical remission and functional remission in Infliximab using the increase-in-quantity protocol to TNF-alpha inhibitory drug resistance rheumatoid arthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical remission and functional remission
Key secondary outcomes
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 |
Interventions/Control_1
The quantity of Infliximab is increased.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)The patient under medical treatment with TNF-alpha inhibitory drugs other than Infliximab
2)age 20 years and over, age 75 years old and below
3)Man and woman
Key exclusion criteria
1)The patient who cannot use MTX
2)The patient who cannot use Infliximab
3)THe patient who ever used Infliximab
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Nishioka |
Organization
Institute of Health Biosciences,
The University of Tokushima Graduate School
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-3111
yasuhiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kishi |
Organization
Institute of Health Biosciences,
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-3111
Homepage URL
kishijun@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Health Biosciences,
The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Institute of Health Biosciences,
The University of Tokushima Graduate School
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2014 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016664
