UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027242 |
|---|---|
| Receipt number | R000031208 |
| Scientific Title | the effect of tofacitinib on bone mineral density in patients with rheumatoid arthritis |
| Date of disclosure of the study information | 2017/05/03 |
| Last modified on | 2017/06/02 08:04:32 |
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Basic information
Public title
the effect of tofacitinib on bone mineral density in patients with rheumatoid arthritis
Acronym
the effect of tofa on BMD in RA
Scientific Title
the effect of tofacitinib on bone mineral density in patients with rheumatoid arthritis
Scientific Title:Acronym
the effect of tofa on BMD in RA
Region
| Japan |
Condition
Condition
to determine the effect of tofacitinib on bone
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the effects of tofacitinib treatments on the BMD of the lumbar spine and femoral neck in patients with RA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
the comparison of the BMD of the lumbar spine and femoral neck at baseline and 52 weeks after tofacitinib treatment.
Key secondary outcomes
the comparison of the bone marker at baseline and 52 weeks after tofacitinib treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tofacitinib
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
RA patients were eligible if they had active disease during the previous 12 weeks despite prior treatment with methotrexate
Key exclusion criteria
patients had received steroids, bisphosphonates, or parathyroid hormone.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kensuke kume |
Organization
hiroshima clinic
Division name
rheumatology
Zip code
Address
higashi kannon 20-16, hiroshima
TEL
0822320707
kumekensuke@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kensuke kume |
Organization
hiroshima clinic
Division name
rheumatology
Zip code
Address
higashi kannon 20-16, hiroshima
TEL
0822320707
Homepage URL
kumekensuke@live.jp
Sponsor or person
Institute
Division of rheumatology, hiroshima clinic
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
Hatta clinic
Sky clinic
Toyohira hospital
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
| 2017 | Year | 05 | Month | 03 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 03 | Day |
Last modified on
| 2017 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031208
| 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 |
