UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040772
Receipt number R000046560
Scientific Title Development of Quantitative Software for Joint Space Narrowing Progression on Radiography for Rheumatoid Arthritis Patients on Tocilizumab
Date of disclosure of the study information 2020/06/22
Last modified on 2022/06/20 14:26:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Development of Software for Finger Joint Space Narrowing Progression for Rheumatoid Arthritis Patients on Drug Therapy

Acronym

Development of Software for Joint Images

Scientific Title

Development of Quantitative Software for Joint Space Narrowing Progression on Radiography for Rheumatoid Arthritis Patients on Tocilizumab

Scientific Title:Acronym

Development of Quantitative Software for Joint Space Narrowing Progression

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine if therapeutic effect can be predicted in a short period of time after administration of Tocilizumab for patients with rheumatoid arthritis

Basic objectives2

Others

Basic objectives -Others

Reproducibility of the software

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To prove correlation in joint space narrowing progression between our proposed system and standard system from baseline to week 52.

Key secondary outcomes

To prove that our proposed system can show joint space narrowing (JSN) progression at week 52 is grater in those with greater JSN progression at week 24.
To show correlation in JSN progression between at week 52 and at week 24 using our proposed system.
To show JSN progression at week 52 is greater than that at week 24 using our proposed system.
To prove the group with higher disease activity at week 0 has significantly greater JSN than that with lower disease activity at followup.


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

100 years-old >

Gender

Male and Female

Key inclusion criteria

1. Those who have a confirmed diagnosis of rheumatoid arthritis based on the 2010 standard
2.Those who have completed one year of Tocilizumab treatment
3. Radiography of the hands at the start of treatment and at 24 and 52 weeks after the start of treatment
4. Those who do not refuse to participate in this research

Key exclusion criteria

1.Those with severe joint destruction-Steinbrocker Stage III (high altitude progression) or higher
2. In addition, the person who the research director judges to be inappropriate as a research target person

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Tamotsu
Middle name
Last name Kamishima

Organization

Faculty of Health Sciences, Hokkaido University

Division name

Dept. of Biomedical Science and Engineering

Zip code

0600812

Address

North-12, West-5, Kita-ku, Sapporo 060-0812, Japan

TEL

011-706-2824

Email

ktamotamo2@hs.hokudai.ac.jp


Public contact

Name of contact person

1st name Tamotsu
Middle name
Last name Kamishima

Organization

Faculty of Health Sciences, Hokkaido University

Division name

Dept. of Biomedical Science and Engineering

Zip code

060-0812

Address

North-12, West-5, Kita-ku, Sapporo 060-0812, Japan

TEL

+81117062824

Homepage URL


Email

ktamotamo2@hs.hokudai.ac.jp


Sponsor or person

Institute

Faculty of Health Sciences, Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Hokkaido University Hospital

Address

Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido

Tel

011-706-7636

Email

crjimu@huhp.hokudai.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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 22 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

2019 Year 11 Month 01 Day

Date of IRB

2019 Year 11 Month 14 Day

Anticipated trial start date

2020 Year 07 Month 31 Day

Last follow-up date

2020 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Software analysis of radiographic images of hands performed at facilities participating in this study in the past, and comparison with clinical findings, blood test data, and treatment responsiveness.


Management information

Registered date

2020 Year 06 Month 15 Day

Last modified on

2022 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046560


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name