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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031850
Receipt No. 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

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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
Email 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
Email kyamaji@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036370

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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