UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033150 |
|---|---|
| Receipt number | 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 | 2021/04/09 17:49:53 |
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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
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
naoki-iwa@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037806
