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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020598
Receipt No. 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

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

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
URL(English) https://upload.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


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