UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016117 |
|---|---|
| Receipt number | 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 17:15:53 |
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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
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
mkitano6@hyo-med.ac.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018721
