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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033150
Receipt No. R000037806
Scientific Title Analysis of the efficacy of baricitinib in bone erosion assessed by HR-pQCT in rheumatoid arthritis.
Date of disclosure of the study information 2018/06/26
Last modified on 2018/06/26

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Basic information
Public title Analysis of the efficacy of baricitinib in bone erosion assessed by HR-pQCT in rheumatoid arthritis.
Acronym Analysis of joint change using HR-pQCT in rheumatoid arthritis treated by baricitinib.
Scientific Title Analysis of the efficacy of baricitinib in bone erosion assessed by HR-pQCT in rheumatoid arthritis.
Scientific Title:Acronym Analysis of joint change using HR-pQCT in rheumatoid arthritis treated by baricitinib.
Region
Japan

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

Objectives
Narrative objectives1 To compare joint change assessed by HR-pQCT among baricitinib treatment and other conventional DMARDs treatment in rheumatoid arthritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change of volume of bone erosion in RA treated by baricitinib and csDMARDs which detected by HR-pQCT from baseline to 12 months.
Key secondary outcomes 1.To evaluate the change of bone microarchitecture using HR-pQCT from baseline to 12 months.
2. To investigate the relation between HR-pQCT and finding of other modality such as musculoskeletal ultrasonography.
3, To investigate the relation between HR-pQCT and biomarkes measured by multiplex bead assays.

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 Baricitinib group;
1.The patients who fulfill 2010 ACR/EULAR criteria of Rheumatoid arthritis.
2.The patients who are indicated of baricitinib treatment.
3.The disease activity score is more 3.2.
4.The patient aged >20 years when signing his/her informed consent.
Control group
1.The patients who fulfill 2010 ACR/EULAR criteria of Rheumatoid arthritis.
2.The patients who are treated by conventional synthetic DMARDs over the 3 months.
3.The disease activity score is more 3.2.
4.The patient aged >20 years when signing his/her informed consent.

Key exclusion criteria 1.Pregnant patients
2.The patients who cannot rest the extremities during taking HR-pQCT.
3.The patients who is treated with prednisone >10mg
4.The patients who are taking intraarticular corticosteroid injection into evaluation joints within 6 months before enrollment.
5.The patients who are complicated with other disease which can affect evaluation joint.
6.In the opinion of the investigator, the patients who is not suitable for this study for other reasons.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Iwamoto
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Reumatology, Unit of Advanced Preventive Medical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8051
TEL 095-819-7262
Email naoki-iwa@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Iwamoto
Organization Nagasaki University Graduate School of Biomedical Sciences
Division name Department of Immunology and Reumatology, Unit of Advanced Preventive Medical Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki, 852-8051
TEL 095-819-7262
Homepage URL
Email naoki-iwa@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Graduate School of Biomedical Sciences
Institute
Department

Funding Source
Organization Eli Lilly and Company
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 06 Month 26 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information no data available

Management information
Registered date
2018 Year 06 Month 26 Day
Last modified on
2018 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037806

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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