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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040027
Receipt No. R000045448
Scientific Title A single-center retrospective observational study evaluating the contribution of platelet volume indices to the response to the treatment with tocilizumab in the patients of rheumatoid arthritis
Date of disclosure of the study information 2020/04/10
Last modified on 2020/04/01

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Basic information
Public title A single-center retrospective observational study evaluating the contribution of platelet volume indices to the response to the treatment with tocilizumab in the patients of rheumatoid arthritis
Acronym A single-center retrospective observational study evaluating the contribution of platelet volume indices to the response to the treatment with tocilizumab in the patients of rheumatoid arthritis
Scientific Title A single-center retrospective observational study evaluating the contribution of platelet volume indices to the response to the treatment with tocilizumab in the patients of rheumatoid arthritis
Scientific Title:Acronym A single-center retrospective observational study evaluating the contribution of platelet volume indices to the response to the treatment with tocilizumab in the patients of rheumatoid arthritis
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Medicine in general Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the predictive role of platelet volume indices in the treatment of the patients of RA with tocilizumab.
Basic objectives2 Others
Basic objectives -Others To evaluate the predictive role of platelet volume indices in the treatment of the patients of RA with tocilizumab.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between the duration of TCZ usage and platelet volume indices before TCZ administration in the patients with rheumatoid arthritis.
Key secondary outcomes DAS28-ESR, DAS28-CRP, CDAI, and SDAI in the patients of rheumatoid arthritis, observed at three, 12, 36 and 60 months after the initiation of administration of TCZ.

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 The patients of rheumatoid arthritis who were diagnosed with the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria or the 1987 ACR criteria at Kansai Medical University Medical center.
The patients of rheumatoid arthritis who were received TCZ at Kansai Medical University Medical center from April 2008 to August 2018.
Key exclusion criteria The patients who lacked adequate medical record.
Target sample size 170

Research contact person
Name of lead principal investigator
1st name Nobuyasu
Middle name
Last name Ishii
Organization Kansai medical university
Division name First department of international medicine
Zip code 5708507
Address Moriguchi-city fumizono-cho 10-15,osaka,japan
TEL +81669921001
Email ishiinob@takii.kmu.ac.jp

Public contact
Name of contact person
1st name Nobuyasu
Middle name
Last name Ishii
Organization Kansai medical university
Division name First department of international medicine
Zip code 5708507
Address Moriguchi-city fumizono-cho 10-15,osaka,japan
TEL +81669921001
Homepage URL
Email ishiinob@takii.kmu.ac.jp

Sponsor
Institute First department of international medicine,Kansai medical university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization The Institutional Review Board for Clinical Reserch of Kansai Medical University Medcal Center
Address Moriguchi-city fumizono-cho 10-15,osaka,japan
Tel +81669921001
Email rinriirb@hirakata.kmu.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 関西医科大学総合医療センター(大阪府)/Kansai medical university medical center

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 10 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 160
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 No longer recruiting
Date of protocol fixation
2020 Year 03 Month 01 Day
Date of IRB
2019 Year 12 Month 25 Day
Anticipated trial start date
2020 Year 03 Month 01 Day
Last follow-up date
2021 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relationship between the duration of TCZ usage and platelet volume indices before TCZ administration in the patients with rheumatoid arthritis.

Management information
Registered date
2020 Year 04 Month 01 Day
Last modified on
2020 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045448

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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