UMIN-CTR Clinical Trial

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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