UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of change in blood leukocyte count by anticoagulant in leukocytapheresis for rheumatoid arthritis
Title of the study (Brief title)	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	Ken Yamaji
Organization	Juntendo University School of Medicine
Division name	Department of Internal Medicine and Rheumatology
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	Ken Yamaji
Organization	Juntendo University School of Medicine
Division name	Department of Internal Medicine and Rheumatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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