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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040094
Receipt No. R000045713
Scientific Title Development of chronotherapeutics in rheumatoid arthritis
Date of disclosure of the study information 2020/07/01
Last modified on 2020/04/07

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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
2) Biomarker (CRP, ESR, MMp-3, RF)
3) 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 3
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
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<60ml/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 90

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Matsui
Organization Hyogo college of Medicine
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
Email k-matsui@hyo-med.ac.jp

Public contact
Name of contact person
1st name Teppei
Middle name
Last name Hashimoto
Organization Hyogo college of Medicine
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
Email te-hashimoto@hyo-med.ac.jp

Sponsor
Institute Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of Medicine
Institute
Department

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 colledge of medicine
Address 1-1, Mukogawa, Nishinomiya
Tel 0798-48-6066
Email 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)、加古川中央市民病院(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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 07 Day
Last modified on
2020 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045713

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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