UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020598
Receipt number R000023773
Scientific Title Study about the standardization of diagnostic criteria and disease severity classification and the development of evidence-based treatment guidelines for pediatric rheumatic diseases such as mainly juvenile idiopathic arthritis
Date of disclosure of the study information 2016/01/18
Last modified on 2017/07/09 22:31:17

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Basic information

Public title

Study about the standardization of diagnostic criteria and disease severity classification and the development of evidence-based treatment guidelines for pediatric rheumatic diseases such as mainly juvenile idiopathic arthritis

Acronym

The standardization of diagnostic criteria and disease severity classification and the development of evidence-based treatment guidelines for pediatric rheumatic diseases

Scientific Title

Study about the standardization of diagnostic criteria and disease severity classification and the development of evidence-based treatment guidelines for pediatric rheumatic diseases such as mainly juvenile idiopathic arthritis

Scientific Title:Acronym

The standardization of diagnostic criteria and disease severity classification and the development of evidence-based treatment guidelines for pediatric rheumatic diseases

Region

Japan


Condition

Condition

Juvenile idiopathic arthritis, childhood-onset systemic lupus erythematosus, childhood-onset Sjogren syndrome

Classification by specialty

Clinical immunology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Among pediatric rheumatic diseases, we build the system watching the long-term side effect that we examine enough domestic and foreign cases and plan the diagnostic criteria in each disease and a disease severity classification and making, enlightenment, the spread of guidelines on diagnosis, treatment of the pediatric characteristics based on evidence mainly on the intractable condition of a patient having high case fatality rate or aftereffects onset rate and establish a disease registration system, and biological preparation brings.

Basic objectives2

Others

Basic objectives -Others

We examine the usefulness of guidelines that we devised

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The development of guidelines and establishment of the disease registration system

Key secondary outcomes



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

0 years-old <=

Age-upper limit

20 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with the target diseases

Key exclusion criteria

None

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaaki Mori

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Department of Pharmacovigilance

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

+81-3-5803-4876

Email

masaaki.mori.mm@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masaaki Mori

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Department of Pharmacovigilance

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan

TEL

+81-3-5803-4876

Homepage URL


Email

masaaki.mori.mm@gmail.com


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Scientific research funds

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


Address


Tel


Email



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

2016 Year 01 Month 18 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

No longer recruiting

Date of protocol fixation

2016 Year 01 Month 18 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

1) Subjective
1. Criteria for selection
-MAS of JIA
-Central nervous system(CNS) lupus of
SLE
-ARDS of JDM
-Chronic fatigue and extra-organ
disorder out of the gland

2)Study design and the number of the targeted subjective
1.Study design
-epidemiology research using the existing medical record information.
2. Number of the study subjects
-Undecided
3. Study enforcement period
A study period: 3/31, 2018
A registration period: 8/31, 2017
The period of the medical treatment record to collect as subjects of survey: December, 2015

3)Observation, inspection item
1. Study entry period of the target person
-We sail up the past information of the period set than a medical record and collect the information of the surveyed patient.
2. Observation, inspection items
-Birthday, sex
-Underlying disease name, age at the time of the underlying disease diagnosis, hospitalization time, the days by the intractable condition of a patient, hospitalization diagnosis, the use actual situation of an immunosuppressant, the steroid, presence of the hospitalized oxygen dosage, intensive care unit management, artificial ventilation, aggravation, outcome of the underlying disease
3. Observation, laboratory procedure
<Investigation into questionnaire form>
-information in facilities specialized in infant rheumatism to belong of an applicable study person in charge or the coworker. The information of the collected case is added up according to a disease and analyzes it by a method determined beforehand.

4)End-point
1. Main end-point
-Death rate main end-point.
2. Other end-point
-The use actual situation of an immunosuppressant, the steroid
-Ratio of hospitalized oxygen dosage
-Ratio of hospitalized artificial ventilation
-Ratio of intensive care unit management
3. Statistical analysis
After the collected data were added up, they are shown by the statistical analysis specialist in this study.


Management information

Registered date

2016 Year 01 Month 17 Day

Last modified on

2017 Year 07 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023773


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name