UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031850 |
|---|---|
| Receipt number | R000036370 |
| Scientific Title | Analysis of change in blood leukocyte count by anticoagulant in leukocytapheresis for rheumatoid arthritis |
| Date of disclosure of the study information | 2018/03/26 |
| Last modified on | 2018/03/23 04:37:44 |
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Basic information
Public title
Analysis of change in blood leukocyte count by anticoagulant in leukocytapheresis for rheumatoid arthritis
Acronym
Analysis of change in blood leukocyte count in leukocytapheresis for rheumatoid arthritis
Scientific Title
Analysis of change in blood leukocyte count by anticoagulant in leukocytapheresis for rheumatoid arthritis
Scientific Title:Acronym
Analysis of change in blood leukocyte count in leukocytapheresis for rheumatoid arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of change in blood leukocyte count by leukocytapheresis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood leukocyte count at baseline, finished and 4weeks after leukocytapheresis.
Key secondary outcomes
Swollen joint count, Tender joint count, C-reactive protein, DAS28(CRP) at baseline, finished and 4weeks after leukocytapheresis.
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
| Device,equipment |
Interventions/Control_1
leukocytapheresis
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the ACR criteria for rheumatoid arthritis.
Patients who are resistant to 2 or more DMARDs or can not be administered DMARDs or biopharmaceuticals because of concomitant disease or infection.
Patients who's disease activity remain high for at least two weeks preceeding LCAP initiation even in the presence of conventional treatment.
Key exclusion criteria
Patients who have active infections.
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Yamaji |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5802-1067
kyamaji@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Yamaji |
Organization
Juntendo University School of Medicine
Division name
Department of Internal Medicine and Rheumatology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5802-1067
Homepage URL
kyamaji@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Medical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 03 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2006 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2018 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036370
