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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001407
Receipt No. R000001711
Scientific Title The Efficacy and Safety of the new biologic agents (humanized anti-human Interlukin-6 receptor monoclonal antibody) on abnormal lipid metabolism and atherosclerosis for rheumatoid arthritis patients in Japan
Date of disclosure of the study information 2008/10/01
Last modified on 2013/10/01

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Basic information
Public title The Efficacy and Safety of the new biologic agents (humanized anti-human Interlukin-6 receptor monoclonal antibody) on abnormal lipid metabolism and atherosclerosis for rheumatoid arthritis patients in Japan
Acronym The Efficacy and Safety of the new humanized anti-human interlukin-6 reCeptor mOnoclonal antibody on abnormal lipid metabolism and atherosclerosis for Rheumatoid arthritis in Japan (The ESCORT study)
Scientific Title The Efficacy and Safety of the new biologic agents (humanized anti-human Interlukin-6 receptor monoclonal antibody) on abnormal lipid metabolism and atherosclerosis for rheumatoid arthritis patients in Japan
Scientific Title:Acronym The Efficacy and Safety of the new humanized anti-human interlukin-6 reCeptor mOnoclonal antibody on abnormal lipid metabolism and atherosclerosis for Rheumatoid arthritis in Japan (The ESCORT study)
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Objective: To evaluate the efficacy and safety of Tocilizumab on lipid metabolism and vascular disorder and to compare with the relationship between disease activity and lipid-related measurements for rheumatoid arthritis patients with inadequate response to DMARDs treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Adiponectin
Remnant like particles-cholesterol
Each type of serum cholesterol
Carotid echo sonography
Key secondary outcomes DAS28 Remission rate
ACR core set
Total Sharp Score

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients who are diagnosed to have rheumatoid arthritis according to the criteria proposed by American College of Rheumatology in 1987

patients with rheumatoid arthritis of more than 6 months duration
Key exclusion criteria RA patients who have serious infection

patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies

patients with Primary or secondary immunodeficiency
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization University of Occupation & Environmental Health
Division name The First Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, JAPAN
TEL 093-603-1611
Email tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Saito
Organization University of Occupation & Environmental Health
Division name The First Department of Internal Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, JAPAN
TEL 093-603-1611
Homepage URL
Email kazu-s@med.uoeh-u.ac.jp

Sponsor
Institute The First Department of Internal Medicine.University of Occupation & Environmental Health
Institute
Department

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
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
2008 Year 10 Month 01 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
Date of protocol fixation
2008 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Objective: to effect of the humanized anti-human monoclonal antibody on lipid metabolism and vascular disorder
Design: prospective observational study
Sampling: consecutive patients who diagnosed as rheumatoid arthritis in University of Occupation & Environmental Health

Management information
Registered date
2008 Year 10 Month 01 Day
Last modified on
2013 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001711

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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