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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027242
Receipt No. 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

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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
Email 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
Email kumekensuke@live.jp

Sponsor
Institute Division of rheumatology, hiroshima clinic
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031208

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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