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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016117
Receipt No. R000018721
Scientific Title Effects of Tocilizumab on Bone Metabolism, RANKL, osteoprotegerin, DKK-1 and osteopontin in Rheumatoid Arthritis.
Date of disclosure of the study information 2018/03/31
Last modified on 2015/01/05

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Basic information
Public title Effects of Tocilizumab on Bone Metabolism, RANKL, osteoprotegerin, DKK-1 and osteopontin in Rheumatoid Arthritis.
Acronym Effects of Biologics DMARDs on Bone Metabolism in Rheumatoid Arthritis.
Scientific Title Effects of Tocilizumab on Bone Metabolism, RANKL, osteoprotegerin, DKK-1 and osteopontin in Rheumatoid Arthritis.
Scientific Title:Acronym Effects of Biologics DMARDs on Bone Metabolism in Rheumatoid Arthritis.
Region
Japan

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

Objectives
Narrative objectives1 To clarify the control mechanism of tocilizumab for bone destruction and systemic osteoporosis in rheumatoid arthritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Serum parameters of bone metabolism, RANKL, osteoprotegerin, DKK-1 and osteopontin after 12 weeks of tocilizumab treatment.
Key secondary outcomes Disease activity after 12 weeks of tocilizumab treatment.

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Adaptation case by the tocilizumab use guideline of Japan College of Rheumatology.
Key exclusion criteria Case outside the patient who can't get consent in a test and the adaptation by a guideline
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hajime Sano
Organization Hyogo College of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798-45-6591
Email hsano@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayasu Kitano
Organization Hyogo College of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798-45-6591
Homepage URL
Email mkitano6@hyo-med.ac.jp

Sponsor
Institute Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department

Funding Source
Organization CHUGAI PHARMACEUTICAL CO.,LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

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 31 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 No longer recruiting
Date of protocol fixation
2012 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observation study

Management information
Registered date
2015 Year 01 Month 05 Day
Last modified on
2015 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018721

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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