UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of pathogenic role of soluble immune semaphorin in autoimmune diseases.
Title of the study (Brief title)	Semaphorin in autoimmune diseases
Region	Japan

Condition
Condition	autoimmune diseases (including rheumatoid arthritis and osteoarticular diseases (including osteoarthritis and osteoporosis)
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of semaphorin status during conventional and biologics treatment in autoimmune and osteoarticular diseases
Basic objectives2	Others
Basic objectives -Others	To establish the significance of semahorin as a new pharmacometrics method in the autoimmune and osteoarticular diseases
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	-disease activity scores (DAS28, -CDAI/SDAI, CRP, MMP3 in RA) -Semahorins (Sema3A, Sema4A, Sema4D) -bone turnover markers -cytokines and proteases
Key secondary outcomes	To evaluate efficacy of conventional and biologics treatment

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Males and females diagnosed autoimmune and osteoarticular diseases including rheumatoid arthritis, osteoarthritis, osteporosis) must -be more than 20 years old -be informed and will give written informed consent
Key exclusion criteria	-complicated with active infectious diseases -The patients who the doctors in charge consider should not enter this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Atsushi Ogata
Organization	Osaka University Graduate School of Medicine
Division name	Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Address	2-2, Yamadaoka, Suita, Osaka Japan 565-0871
TEL	06-6879-3833
Email	ogata@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person	Atsushi Ogata
Organization	Osaka University Graduate School of Medicine
Division name	Department of Respiratory Medicine, Allergy and Rheumatic DIseases
Address	2-2, Yamadaoka, Suita, Osaka Japan 565-0871
TEL	06-6879-3833
Homepage URL
Email	ogata@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
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	2014 Year 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2017 Year 08 Month 13 Day
Date of closure to data entry	2017 Year 08 Month 13 Day
Date trial data considered complete	2017 Year 08 Month 13 Day
Date analysis concluded	2017 Year 08 Month 13 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results	http://onlinelibrary.wiley.com/
Results	Levels of sSema4D were elevated in RA patients, and disease activities were correlated with serum levels of sSema4D. Treatment with an anti-Sema4D antibody suppressed arthritis in CIA. Levels of sSema4D were elevated in ANCA associated vasculitis patients. Neutrophil surface Sema4D functions as a negative regulator of neutrophil activation. Proteolytic cleavage of Sema4D as observed in patients with AAV may amplify neutrophil-mediated inflammatory responses.
Other related information	Yoshida Y, Ogata A, Kang S, Ebina K, Shi K, Nojima S, Kimura T, Ito D, Morimoto K, Nishide M, Hosokawa T, Hirano T, Shima Y, Narazaki M, Tsuboi H, Saeki Y, Tomita T, Tanaka T, Kumanogoh A.Semaphorin 4D Contributes to Rheumatoid Arthritis by Inducing Inflammatory Cytokine Production: Pathogenic and Therapeutic Implications. Arthritis Rheumatol. 2015 Jun;67(6):1481-90. Nishide M, Nojima S, Ito D, Takamatsu H, Koyama S, Kang S, Kimura T, Morimoto K, Hosokawa T, Hayama Y, Kinehara Y, Kato Y, Nakatani T, Nakanishi Y, Tsuda T, Park JH, Hirano T, Shima Y, Narazaki M, Morii E, Kumanogoh A. Semaphorin 4D inhibits neutrophil activation and is involved in the pathogenesis of neutrophil-mediated autoimmune vasculitis. Ann Rheum Dis. 2017 Aug;76(8):1440-1448.

Management information
Registered date	2014 Year 02 Month 05 Day
Last modified on	2018 Year 08 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015256