UMIN-CTR Clinical Trial

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	Open public recruiting
Date of protocol fixation	2018 Year 06 Month 24 Day
Date of IRB	2018 Year 06 Month 19 Day
Anticipated trial start date	2018 Year 07 Month 16 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Analyzing the findings of HR-pQCT.

Management information
Registered date	2018 Year 06 Month 26 Day
Last modified on	2021 Year 04 Month 09 Day

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