UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040027
Receipt number 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 2023/10/10 09:49:47

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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 or person

Institute

First department of international medicine,Kansai 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

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

https://www.dovepress.com/a-single-center-retrospective-observational-study-evaluating-the-favor-pee

Publication of results

Published


Result

URL related to results and publications

https://www.dovepress.com/a-single-center-retrospective-observational-study-evaluating-the-favor-pee

Number of participants that the trial has enrolled

144

Results

We analyzed the contribution of the base line value of C-reactive protein (CRP) to DCT. We divided the patients with RA into two groups according to a cutoff value of 1.000 mg/dl. In univariate analysis, DCT was significantly increased in patients with a high CRP value (P = 0.0283). Multivariate analysis clearly revealed that a high baseline CRP value was an independent favorable predictive factor for longer DCT (hazard ratio, 0.608, 95% CI: 0.378-0.981, P = 0.0416).

Results date posted

2023 Year 10 Month 10 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The medical records of all patients with RA who received treatment with TCZ from April 2008 to August 2018 at Kansai Medical University Medical Center (Moriguchi-City, Japan) were retrospectively reviewed. The clinical diagnosis of RA was made according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria or the 1987 ACR criteria.

Participant flow

Informed consent was obtained in the form of opt-out on the website (http://www.kmu.ac.jp/takii/hospital/scq14r0000000yu1.html)

Adverse events

none

Outcome measures

In terms of disease control time (DCT) other than disease remission rate, no obvious predictive factors have been reported. Therefore, we conducted a retrospective observational study to determine how long TCZ controls RA using a statistical technique with a time-to-event analysis.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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 04 Month 30 Day

Date of closure to data entry

2021 Year 04 Month 30 Day

Date trial data considered complete

2021 Year 07 Month 25 Day

Date analysis concluded

2021 Year 07 Month 25 Day


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

2023 Year 10 Month 10 Day



Link to view the page

Value
https://center6.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