UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056193
Receipt number R000064032
Scientific Title Systematic review of the seroconversion of anti-citrullinated peptide (CCP) antibodies in rheumatoid arthritis
Date of disclosure of the study information 2024/11/20
Last modified on 2024/12/03 12:06:33

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Basic information

Public title

Systematic review of the seroconversion of anti-citrullinated peptide (CCP) antibodies in rheumatoid arthritis

Acronym

A Literature Review of the seroconversion of anti-citrullinated peptide (CCP) antibodies in rheumatoid arthritis

Scientific Title

Systematic review of the seroconversion of anti-citrullinated peptide (CCP) antibodies in rheumatoid arthritis

Scientific Title:Acronym

Systematic review of the seroconversion of anti-citrullinated peptide (CCP) antibodies in rheumatoid arthritis

Region

Japan


Condition

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this review is to determine of the clinical features and factors associated with the seroconversion of anti-citrullinated peptide (CCP) antibodies in patients with rheumatoid arthritis.

Basic objectives2

Others

Basic objectives -Others

The purpose of this review is to determine of the clinical features and factors associated with the seroconversion of anti-citrullinated peptide (CCP) antibodies in patients with rheumatoid arthritis.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Seroconversion of anti-citrullinated peptide (CCP) antibodies in patients with rheumatoid arthritis.

Key secondary outcomes

Factors associated with the development of anti-citrullinated peptide (CCP) antibodies in patients with rheumatoid arthritis


Base

Study type

Others,meta-analysis etc


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Original paper evaluating the development of anti-CCP antibody after diagnosis of rheumatoid arthritis

Key exclusion criteria

1)Unable to assess frequency of Anti-CCP antibody seroconversion
2)Reviews, meta-analysis papers and Research plan
3)Conference abstracts

Target sample size



Research contact person

Name of lead principal investigator

1st name Masaru
Middle name
Last name Kato

Organization

University of Toyama Faculty of Medicine

Division name

The First Department of Internal Medicine

Zip code

930-0194

Address

2630 Sugitani, Toyama, Japan.

TEL

076-434-7287

Email

ktmasaru@med.u-toyama.ac.jp


Public contact

Name of contact person

1st name Ryoko
Middle name
Last name Asano

Organization

University of Toyama Faculty of Medicine

Division name

The First Department of Internal Medicine

Zip code

930-0194

Address

2630 Sugitani, Toyama, Japan.

TEL

076-434-7287

Homepage URL


Email

aryoko@med.u-toyama.ac.jp


Sponsor or person

Institute

First Department of Internal Medicine, University of Toyama

Institute

Department

Personal name



Funding Source

Organization

First Department of Internal Medicine, University of Toyama

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

First Department of Internal Medicine, University of Toyama

Address

University of Toyama Faculty of Medicine

Tel

076-434-7287

Email

aryoko@med.u-toyama.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

2024 Year 11 Month 20 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

14

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

2024 Year 11 Month 03 Day

Date of IRB

2024 Year 11 Month 03 Day

Anticipated trial start date

2024 Year 11 Month 22 Day

Last follow-up date

2024 Year 11 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

In this is a systematic review, we searched PubMed, the Cochrane Library, and Scopus to screen for articles.The inclusion criteria is that evaluated the seroconversion of anti-CCP antibody after the diagnosis of rheumatoid arthritis. The exclusion criteria were 1) articles that could not evaluate the frequency of the development of anti-CCP antibody, 2) review articles, meta-analysis articles, and research protocols, and 3) conference abstracts. The primary outcome was the development of anti-CCP antibodies after the diagnosis of rheumatoid arthritis.


Management information

Registered date

2024 Year 11 Month 19 Day

Last modified on

2024 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064032