UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the mechanism for anti-RNP antibodies in autoimmune diseases
Acronym	Analysis of the mechanism for anti-RNP antibodies
Scientific Title	Analysis of the mechanism for anti-RNP antibodies in systemic autoimmune diseases
Scientific Title:Acronym	Analysis of the mechanism for anti-RNP antibodies
Region	Japan

Condition
Condition	systemic lupus erythematosus, mixed connective tissue disease, systemic sclerosis, rheumatoid arthritis, vasculitis syndrome, drug-induced lupus erytnematosus, healthy condition
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To find aberrant protein expression and post-translational modification of autoantigens in anti-RNP antibody- and the other autoantibody-positive patients and patients-with drug-induced lupus erythematosus
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Levels and post-translational modifications of U1-68k
Key secondary outcomes	Change of protein expression and post-translational modification by drugs

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who have been diagnosed or suspected having the target diseases in St. Marianna University hospital. Healthy individuals who visit St. Marianna University hospital (i.e., for medical check). Healthy individuals who work in St. Marianna University and St. Marianna University hospital.
Key exclusion criteria	Patients who are excluded from the entry by medical doctors (i.e., severe or moderate levels of anemia)
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Manae Middle name Suzuki Last name Kurokawa
Organization	St. Marianna University Graduate School of Medicice
Division name	Disease Biomarker Analysis and Molecular Regulation
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL	81-44-977-8111
Email	manae@marianna-u.ac.jp

Public contact
Name of contact person	1st name Manae Middle name Suzuki Last name Kurokawa
Organization	St. Marianna University Graduate School of Medicice
Division name	Disease Biomarker Analysis and Molecular Regulation
Zip code	216-8511
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
TEL	81-44-977-8111
Homepage URL
Email	manae@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
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	St. Marianna University School of Medicine
Address	2-16-1, Sugao, Miyamae-ku, Kawasaki
Tel	81-44-977-8111
Email	k-sienbu.mail@marianna-u.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	2019 Year 06 Month 01 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	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 01 Day
Date of IRB	2018 Year 02 Month 28 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We are analyzing levels and post-translational modifications of U1-68k in peripheral lymphocytes from the patients with target diseases and healthy individuals.

Management information
Registered date	2019 Year 05 Month 18 Day
Last modified on	2020 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041922