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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017230
Receipt No. R000019886
Scientific Title Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)
Date of disclosure of the study information 2015/04/22
Last modified on 2015/04/22

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Basic information
Public title Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)
Acronym Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)
Scientific Title Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)
Scientific Title:Acronym Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)
Region
Japan

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

Objectives
Narrative objectives1 To determine the correlation between efficacy of tocilizumab and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Levels of change in oxidative stress markers at 0, 6, and 12 months
Key secondary outcomes

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
Medicine
Interventions/Control_1 Biologic treatment (tocilizumab)
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 1)Patient diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis.
2)Patients who received a full explanation upon participation in this study.
3)Based on the Japan College of Rheumatology "tocilizumab use guidelines for rheumatoid arthritis (RA) (2012 Revised Edition)", patients who meet the following criteria
1:Rheumatoid arthritis patients uncontrolled the use of existing anti-rheumatic drugs to continue the normal dose treatment for 3 months or more.





Key exclusion criteria 1)The patients have an obvious infection in by just before treatment administration, and research investigator or research sharing doctor has determined that they are inappropriate for this study.
2)Based on the Japan College of Rheumatology "tocilizumab use guidelines for rheumatoid arthritis (2012 Revised Edition)", the patients correspond to the administration contraindication
3)The Patients who were considered as inappropriate by the other research doctors based on the medical backgrounds.
4)Under 20 years old
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Akashi
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Biosystemic Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 0926425225
Email hniiro@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Niiro
Organization Graduate School of Medical Sciences, Kyushu University
Division name Department of Medicine and Biosystemic Science
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 0926425233
Homepage URL
Email hniiro@med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
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
2015 Year 04 Month 22 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 Enrolling by invitation
Date of protocol fixation
2012 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2015 Year 04 Month 22 Day
Last modified on
2015 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019886

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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