UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013076 |
|---|---|
| Receipt number | R000015256 |
| Scientific Title | Analysis of pathogenic role of soluble immune semaphorin in autoimmune diseases. |
| Date of disclosure of the study information | 2014/02/10 |
| Last modified on | 2018/08/11 18:49:52 |
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Basic information
Public title
Analysis of pathogenic role of soluble immune semaphorin in autoimmune diseases.
Acronym
Semaphorin in autoimmune diseases
Scientific Title
Analysis of pathogenic role of soluble immune semaphorin in autoimmune diseases.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Atsushi Ogata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic Diseases
Zip code
Address
2-2, Yamadaoka, Suita, Osaka Japan 565-0871
TEL
06-6879-3833
ogata@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Ogata |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Respiratory Medicine, Allergy and Rheumatic DIseases
Zip code
Address
2-2, Yamadaoka, Suita, Osaka Japan 565-0871
TEL
06-6879-3833
Homepage URL
ogata@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/
Number of participants that the trial has enrolled
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.
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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015256
