UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012807
Receipt number R000014954
Scientific Title Japanese study of Anti-ccp antibody SCreENing methoD in general health check up
Date of disclosure of the study information 2014/01/10
Last modified on 2023/01/18 09:28:05

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Basic information

Public title

Japanese study of Anti-ccp antibody SCreENing methoD in general health check up

Acronym

J-ASCEND

Scientific Title

Japanese study of Anti-ccp antibody SCreENing methoD in general health check up

Scientific Title:Acronym

J-ASCEND

Region

Japan


Condition

Condition

Rheumaid Arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate diagnostic performance of anit-CCP antibody test as a
screening test at medical health checkup in general population.

Basic objectives2

Others

Basic objectives -Others

To evaluate the impact of anti-CCP antibody screening on patients'
outcome and its economic effect.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The positivity rate of anti-CCP antibody in general population and
number of the patients who are diagnosed as rheumatoid arthritis by
this screening method.

Key secondary outcomes

Patients' outcome and economic effect of anti-CCP antibody screening test.


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

We check anti-CCP antibody in people who visits our health check up institutions and agree to the test.

Key exclusion criteria

Patients who already has been diagnosed as rheumatoid arthritis or who disagrees to this study are excluded.

Target sample size

25000


Research contact person

Name of lead principal investigator

1st name Masato
Middle name
Last name Okada

Organization

St.Lukes International Hospital

Division name

Division of Allergy and Rheumatology

Zip code

1048560

Address

9-1 Akashi-cho, Chuo-Ku, Tokyo

TEL

03-3541-5151

Email

bestlupusdoctorever@gmail.com


Public contact

Name of contact person

1st name Masato
Middle name
Last name Masato

Organization

St.Lukes International Hospital

Division name

Division of Allergy and Rheumatology

Zip code

1049560

Address

9-1 Akashi-cho, Chuo-Ku, Tokyo

TEL

03-3541-5151

Homepage URL


Email

bestlupusdoctorever@gmail.com


Sponsor or person

Institute

St.Lukes International Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

SLIH

Address

9-1Akashi-cho

Tel

0335415151

Email

bestlupusdoctorever@gmail.com


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

2014 Year 01 Month 10 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

1500

Results

RA

Results date posted

2023 Year 01 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

DOCK

Participant flow

DOCK

Adverse events

None

Outcome measures

RA

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB

2013 Year 03 Month 01 Day

Anticipated trial start date

2013 Year 11 Month 01 Day

Last follow-up date

2015 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

After obtainig the consent, they were collected serum samples. Anti-CCP antibody and rheumatoid factor are examined. Antibody-positive persons are examined by Rheumatologists directly, and classified as follows; 1. Early RA group: the person with the diagnosis of rheumatoid arthritis, 2. Pre-RA groups: the person with joint symptoms, 3. Non-RA group: the person with no symptoms. Then they are followed up at regular intervals. For early RA group, its treatment is done by Rheumatologist in line with guidelines. When they develop rheumatoid arthritis, they will be treated as in the early RA group. After this study started, disease activity measure (CDAI, SDAI, DAS28, DAS28-CRP), ADL(HAQ-DI), X ray evaluation (modified Total Sharp Score), and medical cost will be checked annualy.


Management information

Registered date

2014 Year 01 Month 09 Day

Last modified on

2023 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014954


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name