UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040094 |
|---|---|
| Receipt number | R000045713 |
| Scientific Title | Development of chronotherapeutics in rheumatoid arthritis |
| Date of disclosure of the study information | 2020/07/01 |
| Last modified on | 2024/10/29 16:09:22 |
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Basic information
Public title
Development of chronotherapeutics in rheumatoid arthritis
Acronym
Development of chronotherapeutics in rheumatoid arthritis
Scientific Title
Development of chronotherapeutics in rheumatoid arthritis
Scientific Title:Acronym
Development of chronotherapeutics in rheumatoid arthritis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of baricitinib, taken in the morning or in the evening, to verify optimal dosing time and dosage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achievement rate of ACR20 at week 12
Key secondary outcomes
1) change of DAS28ESR and CDAI (week 4, 8, 12, 24, 52)
2) the remission rate of DAS28ESR and CDAI (week 12)
3)Achievement rate ofACR20 (week 4, 8, 24, 52), 50, 70 (week 4, 8, 12, 24, 52)
4) Biomarker (CRP, ESR, MMp-3, RF)
5)change of ACR core set (week 4, 8, 12, 24, 52)
6) Radiograghic X ray
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
baricitinib 4mg morning
Interventions/Control_2
baricitinib 4mg evening
Interventions/Control_3
baricitinib 2mg evening
Interventions/Control_4
baricitinib 2mg morning
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
RA patients who fulfill the following criteria in Hoyogo Colledge of Medicine, Kobe Kaisei Hospital, Konan Kakogawa Hospital, or Kakogawa central city Hospital.
1)Written informed consent provided
2)RA satisfying either the 1987 ACR criteria or 2010 ACR/EULAR criteria
3)active disease with methotrexate treatment or oral conventional synthetic DMARDs for over 3 months (stable dose for at least 4 weeks)
4)Prior use of biological agent is permitted
Key exclusion criteria
1)chronic kidney (eGFR<50ml/min/1.73m2)
2)svere infection or tuberculosis
3)Neutrophils<500/ul, lymphocytes<500/ul
4)Pregnant woman
5)Complication of malignant tumor
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Matsui |
Organization
Hyogo medical University
Division name
Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa, Nishinomiya 663-8501, Japan
TEL
0798-48-6591
k-matsui@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Hashimoto |
Organization
Hyogo Medical University
Division name
Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine
Zip code
663-8501
Address
1-1, Mukogawa, Nishinomiya 663-8501, Japan
TEL
0798-48-6591
Homepage URL
te-hashimoto@hyo-med.ac.jp
Sponsor or person
Institute
Department of Diabetes, Endocrinology and Clinical Immunology, School of Medicine, Hyogo Medical University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University
Address
1-1, Mukogawa, Nishinomiya
Tel
0798-48-6066
rinri@hyo-med.ac.jp
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
兵庫医科大学病院(兵庫県)、神戸海星病院(兵庫県)、甲南加古川病院(兵庫県)、神戸市立医療センター西市民病院(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 07 | Day |
Last modified on
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045713
