UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Masaaki Mori
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Pharmacovigilance
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	Masaaki Mori
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Pharmacovigilance
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 01 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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