UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001407 |
|---|---|
| Receipt number | 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 10:58:13 |
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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
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
kazu-s@med.uoeh-u.ac.jp
Sponsor or person
Institute
The First Department of Internal Medicine.University of Occupation & Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001711
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
